Note: The job is a remote job and is open to candidates in USA. The University of Pennsylvania is a leading education, research, and innovation institution with the Abramson Cancer Center conducting innovative oncology clinical trials. The Clinical Research Coordinator will organize, coordinate, and implement complex cancer studies, managing recruitment, participant visits, data collection, specimen handling, regulatory documentation, and protocol compliance. The role may also support investigator-initiated studies, clinical data analysis, budgets, publications, and mentoring depending on the coordinator level.
Responsibilities
- The CRC will be responsible for the coordination of complex oncology clinical research protocols, including accurate data collection and overseeing the quality of the clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training. The CRC is also responsible for research lab specimen processing/handling. The CRC will demonstrate vigilance in patient safety, protocol compliance, and data quality, and will participate in data organization for research publications, with potential for co-authorship
- Coordinate the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the ACC CRU Leukemia Research Team
- Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes
- Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the ACC CRU Research Team Program Manager
- Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential participants in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family
- Develop, schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities)
- Monitor participants per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality
- Communicate clinical trial patient activity to the investigational drug pharmacy (IDS) to ensure adequate drug supply. Coordinate investigational agent supply ordering with sponsor and IDS as needed. Ensure drug accountability and appropriate investigational agent diary completion
- Participate in the development/maintenance of electronic study specific case report forms (i.e., REDCap, CTMS etc.) and source document tools. Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and research charts
- Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms typically within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting
- On behalf of the site, participate in weekly or bi-weekly Sponsor teleconferences to review the status of ongoing patients and slot assignments/allocations for next dose levels; share study-wide updates/issues with the Research Team’s Program Manager and study team members who were not able to participate. Coordinate and participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Provide regular study and enrollment updates to the research team. Work as a part of the research team to maximize the efficiency and quality of research performed, including developing work instructions
- May act as a mentor to coordinators who have joined the unit with less research experience
- This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to the supervisor
- Work directly with physicians to assist with design, set-up and execute studies. Be responsible for writing investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; contribute to the preparation of study abstracts, posters, manuscripts, and grant applications
- May participate in and support budget preparation for trials as needed. May support a clinical trial budget through each phase of development, resolving issues and queries with input from the Research Team’s PM/PI as required
- Independently coordinate complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) clinical trials and registries within the ACC CRU Research Team. May schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice, detailed documentation of study activities
- Act in lead capacity in coordination of ACC CRU Research Team projects and assist Research Team Managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support (e.g., regulatory submissions and data entry)
- May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues
- Position involves potential cross coverage and/or re-assignment amongst ACC CRU Research Teams depending on business needs. Position is contingent on continued funding
Skills
- Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required
- Practical experience coordinating the day-to-day activities of multiple research projects
- Effective verbal and written communication skills
- Ability to learn new methods quickly and multi-task
- Demonstrated ability to work as part of a team as well as independently
- Ability to work flexible hours
- Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines
- Bachelor's degree and 4-5 years of experience, or equivalent combination of education and experience, are required
- Practical experience coordinating the day-to-day activities of multiple therapeutic research protocols
- Effective verbal and written communication skills
- Ability to learn new methods quickly and multi-task
- Demonstrated ability to work as part of a team as well as independently
- Ability to work flexible hours
- Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines
- Knowledge or experience in cancer preferred but not required
Benefits
- Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare.
- You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
- You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
- Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis, with a wide variety of investment options through TIAA and Vanguard.
- Penn provides you with a substantial amount of time away from work during the course of the year.
- Penn offers faculty and staff and their eligible family members long-term care insurance. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
- A wide variety of wellness and work-life programs and resources to help care for your health, family, and work-life balance.
- An array of resources to help you advance yourself personally and professionally.
- Access to a wide range of University resources as well as cultural and recreational activities, including University libraries, athletic facilities, the arboretum, and art galleries. Eligible activities and offerings may be free for employees and their families.
- Discounts and special services, including free and discounted admission and memberships at Penn arts and cultural centers and museums, and savings on goods and services such as cars, cellular phone service plans, movie tickets, and theme park admission.
- Flexible work options involving non-traditional work hours, locations, and/or job structures.
- Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
- Penn will reimburse eligible employees for qualified expenses connected with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
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