Clinical Project Associate

Clinical Project Associate

OrganOx · Abilene, TX

ABOUT ORGANOX: OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. Position Summary The Clinical Project Associate (CPA) is responsible for working with research sites and the clinical research team to facilitate the successful and timely conduct of clinical investigation(s), building relationships, and effectively communicating ideas and results. The CPA participates in most phases of ongoing clinical investigation(s) including Study Initiation, Enrollment, and Study Closure. The CPA contributes to ongoing studies by performing on-site monitoring visits and remote monitoring visits (with oversight); centralized monitoring, following up on monitoring visit action items; maintaining in-house study files; providing day-to-day study management and site support; interfacing with site coordinators, investigators, field clinical staff, and other company representatives. The CPA ensures study and site compliance with applicable federal regulations and OrganOx policies and procedures. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. This is a remote position in the United States. Major Responsibilities Under direction from the Director, Clinical Affairs, the Clinical Project Associate will be responsible for the following: · Assist in the review of protocols, data collection methods and training materials. · Assist in the development and review of study documents, including nomination and screening forms, monitoring plan, informed consent and study agreements. · Ensure that documentation from investigators and study sites meets FDA and OrganOx requirements. · Prepare and maintain complete and accurate in-house study files, including original study documents, training documents, inventory, site regulatory documentation, and correspondence during the course of the study. Audit in-house study files for compliance to departmental standards. · Assist sites with IRB submission process. Assist sites with IRB renewal process and tracks continuing IRB renewals. Ensure site compliance with IRB requirements. · Support OrganOx in maintaining current and developing new professional relationships with investigators and study sites for assigned study. · Demonstrate critical thinking to recognize data discrepancies, compliance, and/or regulatory issues and interface with site staff and project team for resolution. · Identify and report serious compliance issues to clinical management and participate in implementing action plans. · Provide training to site and field personnel in protocol requirements. · Provide training to site coordinators, investigators, and field clinical staff in collecting data in a timely manner that meets the protocol requirements. Assist site coordinators, investigators, field clinical staff, and sales representatives in collecting data appropriately. · Review data submitted to OrganOx for completeness and accuracy. · Review aggregate clinical data for scientific validity and interface with project team to resolve discrepancies. · Assist in the development and implementation of a study-specific clinical database. · Identify logistical and operational issues and work with clinical management to develop solutions. Effectively communicates solutions to field and site personnel. · With oversight, conduct on-site and remote monitoring visits as well as centralized monitoring within timelines and according to the monitoring plan and OrganOx procedures. Apply FDA regulations, ICH/GCP guidelines and OrganOx procedures to monitoring activities. · Create professional, accurate and succinct queries and action items per OrganOx procedures and follow queries and action items to resolution. · Complete Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per OrganOx procedures and work with sites to resolve action items between monitoring visits. · Provide input on departmental decisions related to process and procedures. · Interface with other departments as necessary · Provide support and assistance to team members in completing other trials when necessary. · Adhere to and demonstrate proficiency in implementing departmental SOPs and policies. Escalate procedural discrepancies to Manager. · Assist the Manager with team, department and study related projects as requested including audits, investigator meetings, training, continuous quality improvement, etc. · Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies Requirements Skills & Experience • Preferred demonstrated aptitude and knowledge in relevant therapeutic area (Transplant Surgery and/or medical device research) and ability to learn and integrate new or different therapeutic areas. • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. • High attention to detail and accuracy. • Proficient knowledge of medical terminology. • Excellent time management and organizational skills. • Excellent professional writing and oral communication skills. • Excellent interpersonal skills. • Ability to work independently as well as part of a team. • Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel). Qualifications • Bachelor's or Graduate degree in a life science, nursing or other health related disciplines. • Must have a valid US driver's license. • 2 years clinical research experience in medical device or pharmaceutical industry or CRO as a CRA, clinical trial assistant, research site role or similar role. • Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials. • Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred. • Ability to travel 10% of the time for training, investigator meetings, monitoring responsibilities, corporate meetings, and educational seminars. • Physical Demands: While performing the duties of this job, the employee is regularly required to talk and hear. The position may require sitting for significant periods of the day while working on the computer. The employee must occasionally lift or move items weight up to 50 pounds. • Work Environment: This is a work-from-anywhere, remote job wherein meetings and collaborations can occur across multiple time zones. A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. . Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development

Clerical Assistant 3

GovernmentJobs.com · Wichita, KS

The Position Are you looking for a great opportunity to utilize your experience and knowledge to perform complex clerical work at an agency that stresses the importance of ethics, integrity, and accountability? If so, this is the position for you! This Clerical Assistant 3 position at the Office of State Inspector General (OSIG) performs complex clerical work which supports our investigative programs. Success in this role relies on knowledge and application of Department of Human Services (DHS) and OSIG procedures and systems, call center experience, knowledge of various software packages, and the ability to exercise independent judgment throughout the course of its duties. Step into a role that values your attention to detail and dedication. This position answers customer calls on a multi-line wireless telephone system and completes variety of complex clerical duties. Work is performed with considerable independence using analytical, organization, and customer service skills and applying sound judgment. As a Clerical Assistant 3, you will perform the following duties: • Tip Call Processing: Enter tips received via welfare fraud tipline, make data and narrative entries in accordance with office procedure and confidentiality policy • Claim Call Response: Review data and provide information to callers about overpayments, intercepts, and related situations; discuss and explain claim computations and resolution processes • Investigation Support: Analyze tips and research claim data to determine if the case should be forwarded to investigative staff • Record Management: Label, organize, retrieve, and keep files current for multiple programs • Process Assistance: Review documents, prepare correspondence, enter and track data, monitor reports, and perform related work as assigned Interested in learning more? Additional details regarding this position can be found in the position description. Work Schedule and Additional Information: • Full-time employment • Work hours are 8:00 AM to 4:30 PM, Monday - Friday, with 60-minute lunch. • Telework: You may have the opportunity to work from home (telework) part-time up to eight days per month based on operational needs. In order to telework, you must have a securely configured high-speed internet connection and work from an approved location inside Pennsylvania. If you are unable to telework, you will have the option to report to the headquarters office in Harrisburg. The ability to telework is subject to change at any time. Additional details may be provided during the interview. • Salary: In some cases, the starting salary may be non-negotiable. • You will receive further communication regarding this position via email. Check your email, including spam/junk folders, for these notices. Required Experience, Training & Eligibility Qualifications Minimum Experience and Training Requirements: • One year as a Clerical Assistant 2 (Commonwealth job title or equivalent Federal Government job title, as determined by the Office of Administration); or • One year of moderately complex clerical experience; or • An equivalent combination of experience and training. Additional Requirement: • You must have one year experience in a call center environment. • You must adhere to the values and ethics of the OSIG. • You must have solid written and verbal communication skills. • You must have the ability to multi-task. • You must be able to perform essential job functions. Preferred Qualifications (not required): • Experience analyzing electronic data and creating or manipulating Excel data spreadsheets • Experience working with Department of Human Services databases or systems such as Client Information System (CIS) or Automated Restitution Referral and Computation (ARRC) • Customer service experience • Experience handling or maintaining confidential information • Experience proofreading documents Legal Requirements: • A conditional offer of employment will require submission of criminal history reports. See hiring agency contact information. • You must pass a background investigation. • This position will have access to Federal Tax Information (FTI) and is subject to the provisions of IRS Publication 1075 (Pub 1075) which requires you to pass an enhanced background check prior to beginning employment. Under Pub 1075, acceptance of a conditional offer of employment will require submission to and approval of satisfactory criminal history reports, including but not limited to: a fingerprint-based federal records check; a PA State Police clearance; a check of local law enforcement agencies where you have lived, worked, and/or attended school within the last five (5) years; and a citizenship/residency verification. • Please note: Due to Act 29, the agency the selected candidate will be serving has limited law enforcement powers and requires all employees with access to agency systems to undergo fingerprinting and an in-depth background check to include criminal, tax, and credit history. How to Apply: • Resumes, cover letters, and similar documents will not be reviewed, and the information contained therein will not be considered for the purposes of determining your eligibility for the position. Information to support your eligibility for the position must be provided on the application (i.e., relevant, detailed experience/education). • If you are claiming education in your answers to the supplemental application questions, you must attach a copy of your college transcripts for your claim to be accepted toward meeting the minimum requirements. Unofficial transcripts are acceptable. • Your application must be submitted by the posting closing date. Late applications and other required materials will not be accepted. • Failure to comply with the above application requirements may eliminate you from consideration for this position. • All application materials and interview responses must reflect the applicant's own experience, qualifications, and work. Applicants may use generative AI tools for preparation purposes only. Use of AI to misrepresent or falsify information, or to assist during interviews, is not permitted. Review the Guidance for Generative AI Tools & Job Seekers for additional information. Veterans: • Pennsylvania law (51 Pa. C.S. §7103) provides employment preference for qualified veterans for appointment to many state and local government jobs. To learn more about employment preferences for veterans, go to www.pa.gov/agencies/employment/how-to-apply.html and click on Veterans. Telecommunications Relay Service (TRS): 711 (hearing and speech disabilities or other individuals). If you are contacted for an interview and need accommodations due to a disability, please discuss your request for accommodations with the interviewer in advance of your interview date. The Commonwealth is an equal employment opportunity employer and is committed to a diverse workforce. The Commonwealth values inclusion as we seek to recruit, develop, and retain the most qualified people to serve the citizens of Pennsylvania. The Commonwealth does not discriminate on the basis of race, color, religious creed, ancestry, union membership, age, gender, sexual orientation, gender identity or expression, national origin, AIDS or HIV status, disability, or any other categories protected by applicable federal or state law. All diverse candidates are encouraged to apply.

Director of Sales

LBA Hospitality · Altamonte Springs, FL

Job Type Full-time Description Fully develops assigned segments with an emphasis against the development of new business for assigned hotel. Works with the General Manager, Regional Revenue Manager and the Regional Director of Sales, to optimally merchandise revenue potential for assigned property and ensure customers have a memorable hotel experience. Develop and execute Sales action plans, maintain positive interdepartmental relations and complete special projects as assigned by the General Manager, Regional Director of Sales and/or Vice President of Sales and Marketing. Success is determined through achievement of the hotels revenue goals and improvement, where possible, in market shared performance as compared to that of the hotel(s) defined competitors. PREREQUISITES Company associates have access to guestrooms and property. As such, character traits of honesty and trustworthiness are essential to this position and must be displayed at all times. Per company policy, potential associates must pass appropriate security clearances. • High school diploma or equivalent; College Degree (BS/BA) preferred or equivalent work experience • Previous direct selling experience in a hotel required including performing outside sales calls • Demonstrated success in developing a market. • Experience selling Marriott, Hilton, Best Western and IHG hotels -Hilton Focus Service, and/or Full Service (where applicable) and/or Extended Stay lodging to all market segments is preferred to include weekday/weekend business. • Hotel operations experience preferred. SUMMARY OF ESSENTIAL JOB FUNCTIONS • Must be able to perform major life activities: Standing, lifting, bending, learning, reading, concentrating, thinking, and communicating. • Must be able to push or pull 60 pounds unassisted and lift and/or carry 30 pounds unassisted. • Must be able to see and hear. • Must be able to speak and read English, the ability to communicate in another language may be helpful. Requirements REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Knowledge: • Knowledge of the market area for the hotel is preferred. • Knowledge of effective outside sales tactics required • Thorough understanding of client base Skills: • Effective communication skills both written and verbal. • Proficient written and verbal English • Financial analysis skills to assess potential business opportunities and whether or not they contribute to the success of the business. • Strong organizational and multitasking skills • Relates well with others and is flexible to work with a team • Analyze work for accuracy of self and others. • Proficiency in Microsoft Outlook, Microsoft Word, Excel, PowerPoint. Experience working with customer relationship software like Delphi.fdc and/or STS preferred. Abilities: • Ability to effectively influence others and engage clients and coworkers on difficult issues. • Ability to inspire confidence in and gain respect from superiors, peers, subordinates, industry partners and competitors. • Combines a confident, self-starting, high performance orientation with track record that reflects a "can do" attitude. • Enjoys interacting with customers and networking within the industry. • Must be able to have a high level of decision making and discretion. • Must be able to work independently to successfully achieve sales goals established for the property. SPECIFIC RESPONSIBILITIES • Handle inquiry calls, proposals, negotiations, and contracts according to departmental procedures. • Books appropriate business that allows hotel to achieve/exceed monthly room revenue budget, and, if applicable, other revenue budgets specific to assigned hotel. • Approaches the position with a relationship building/proactive selling mindset. Ensures that weekly telephone prospecting/qualification/solicitation calls goals as well as outside call goals are met or exceeded based on guidelines agreed to in the Commitments to Success. • Include General Manager on appropriate sales appointments as well as calls on Corporate-based Sales personnel for assistance as needed to "win" business. • Uses property's computerized sales management system to manage the hotel's business, including but not limited to adding all sales activities, generating weekly sales report, entering business, blocking meeting space if hotel has it and building accounts. • Remain in active status in a minimum of two outside organizations including but not limited to: Local Convention and Visitors Bureau, Chamber of Commerce, Sports Commission, university affiliations etc. • Generates sales contracts and BEO's (if applicable) within LBA guidelines. Also develops, presents business case as needed on LNR and Group business if the business falls outside of established group rates and allotments. Deploys seasonal and segmented promotions and packages where needed to drive bookings. • Understands and utilizes available business tools to prospect for new business (i.e., Brand database reports, Construct Connect, ZoomInfo, Agency 360 where applicable, local newspaper and business journals, etc.) and utilizes internal lead source generators such as in house guest lists and brand reporting to maximize revenue production for assigned hotel. • Target, saturate, penetrate specific companies to reach true decision makers in position to refer to our hotel(s) while seeking new business and/or working an existing account. • Strives to continually improve his/her general business and industry/job specific skills by attending Brand and LBA Corporate-sponsored sales training, and, if appropriate, outside continuing education. • Motivates, coaches, counsels and disciplines all sales department personnel (as applicable) according to LBA Hospitality standards. • Monitors economic/business news in general and news specific to assigned market segments. Understands the business rationale behind and contributes, as appropriate, to the hotel's rooms forecast. • Understands the need to follow up and regular communicate with clients to stay engaged in relationship to either book or maintain business. • Understands the business rationale to complete the annual budgeting process, revenue generation, advertising and promotion costs. WORKING CONDITIONS/SPECIAL REQUIREMENTS • This position requires a physical presence at the hotel and is not conducive of telecommuting or remote work. • The ability to drive on behalf of the company and maintaining a valid driver's license is required. • Typical week consists of a minimum of three days out of the office on sales calls and two days in the office working on sales plan. • May be required to come in on the weekends to ensure meeting or group satisfaction. • Periodic overnight travel will be required to attend company/brand conferences, to assist with sales blitzes/training, or attend client events. POSITIONS FOR POSSIBLE ADVANCEMENT • Area Director of Sales • Dual Director of Sales • General Manager Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

Track Laborer System Driver- Fort Worth, TX

Union Pacific Corporation · Fort Worth, TX

Track Laborer System Driver- Fort Worth, TX Join our team of track laborers with a record of building and repairing track for Union Pacific for more than 150 years! As a Track Laborer - System Driver, you'll perform the maintenance, repairs and installations vital to the safe and efficient movement of trains to serve customers throughout North America! We are powered by our people, will you join our team? Required Certifications: This position requires a CDL upon hire. You must meet the following Motor Vehicle and Medical Requirements: • Must be a minimum of 21 years of age • Have valid driver's license • Have an acceptable driving record per your Motor Vehicle Record (MVR) • Medical Requirements: Must meet the medical requirements (also called physical qualifications) for commercial motor vehicle drivers as specified by the US Federal Motor Carrier Safety Administration (FMCSA). Accountabilities: • Conduct regular inspections of tracks, including beds and right-of-way, to identify any issues or defects. • Replace or repair rails, rail anchors, spikes, ballast, ties, and other track components as necessary. • Assist in the unloading and movement of track materials and equipment from rail cars, carts, or trucks. • Operate equipment such as excavators or trenchers to perform tasks such as digging holes and trenches. • Maintain track beds by clearing vegetation and brush, as well as removing dust or snow from movable track parts through sweeping, picking, and digging. • Adhere to company and industry safety rules, practices, and procedures to ensure a safe working environment. • Drive company vehicles as required for job duties. • Foster positive working relationships with colleagues, supervisors, contractors, and customers, and effectively resolve any issues that may arise. • Ensure compliance with all safety, operational, and Federal Railroad Administration (FRA) regulations and rules. • Perform additional assigned tasks or responsibilities as needed. Qualifications - Required: • Applicants must have reached the age of 21 or above. • Able to understand and apply safety rules, practice safe work habits, identify safety risks and avoid potentially risky behaviors and situations • Commercial Drivers License (CDL) Class A or Class B • Proficient verbal and written communication skills to deliver information to coworker(s) and supervisor(s) • Able to read and comprehend regulations and instructions • In order to be considered for this position, candidates are required to successfully complete an assessment in English before proceeding to the interview stage. Qualifications - Preferred: • Experience operating heavy equipment such as construction, farm, etc. (consider professional, personal, and volunteer experience) • Willing to work on-call, overtime, various shifts, 7 days a week, as well as weekends and holidays • Experience of 1 year or more in Railroad Maintenance of Way work • Experience working in a construction-type setting (consider professional, personal, and volunteer experience) • Experience welding or a welding certificate (consider professional, personal, and volunteer experience) Physical and Mental Job Requirements: • Candidates are required to successfully pass a Physical Ability Test (PAT) before being considered for employment. This is separate from the medical exam. • Physically Demanding Tasks: Must have the capacity to engage in physically demanding tasks, including occasional bending, stooping, and kneeling. • Lifting and Carrying: Must be able to occasionally lift and carry items weighing up to 65 lbs, as well as push and pull objects up to 119 lbs. • Standing: Must be capable of standing for extended periods during the workday, with the flexibility to change positions periodically for comfort. • Walking: Safely walk and maintain balance on uneven surfaces. • Climbing: Must be able to climb ladders to access truck storage as necessary. Work Conditions: • Must be legally authorized to work in the United States without requiring company sponsorship. • Must have reliable transportation for commuting to work. • Willingness and ability to work around large equipment such as railcars, locomotives, and cranes. • Must agree to wear personal protective equipment (PPE) including safety glasses, safety boots, hard hats, and hearing protection as required by the company. • Travel Requirements: Extensive travel may be necessary across Union Pacific's 23 state system, often with short notice. Assigned to traveling system work gangs (work groups) engaged in track projects throughout the Union Pacific System. Work takes place in various rural and remote geographic areas. Work may be seasonal, influenced by weather, business conditions, or seniority. Apply only to locations where you are willing and prepared to live and work. Schedules may consist of five 8-hour days with 2 days off, four 10-hour days with 3 days off, or ten 8-hour days followed by accumulated rest days. Union Pacific strives to attract all available talent. We are committed to creating an environment where all people can be their best, personally and professionally, as we remain a merit and performance-based company. What we offer: • A strengths-based, engagement-focused, and performance-oriented culture • Ongoing learning, development, and Educational Assistance (including little to no out-of-pocket cost for online and in-person courses at the University of Nebraska at Omaha and Metropolitan Community College) • 401(k) retirement plan • Employee Stock Purchase Plan with 20% match up to 5% • Medical, dental and vision insurance, which are collectively bargained for through union membership • Wellness and Employee Assistance Programs