Clinical Research Coordinator B/C (Hybrid Eligible)(Abramson Cancer Center) - University of Pennsylvania

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Posted Job Title

Clinical Research Coordinator B/C (Hybrid Eligible)(Abramson Cancer Center)





Job Profile Title

Clinical Research Coordinator B





Job Description Summary

The Clinical Research Unit (CRU) Cellular Therapy and Transplant (CTT) Research Team at the Abramson Cancer Center of the University of Pennsylvania seeks a full-time Clinical Trials Coordinator to organize, coordinate and implement studies involving a wide variety of investigational products and various sponsors. He/she will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and follow-up and trial documentation.





Job Description


Clinical Trials Coordinator B:


This individual will work under general supervision.


Assist CTT program manager with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. 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 supervisor.


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 CTT Clinical Research Program. Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. 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 subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.).


Participate in clinic to explain the trial and provide informed consent to the patient and family. Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (“GCP”) (e.g. scheduling subject 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). Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed. Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.


Participate in the development/maintenance of study specific case report forms and source document tools. May include the development and management of REDCAP web sites for internet data capture. 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 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 unit managers 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. Prepare agendas and record minutes for circulation. Provide regular updates to the research team and unit managers. Assist unit managers in meeting project timelines. Participate in working groups within the Cellular Therapy and Transplant Clinical Research Program that will maximize the efficiency and quality of research performed, including developing SOP’s. May act as a mentor to coordinators who have joined the unit with less research experience




Clinical Trials Coordinator C:


The Clinical Trials Coordinator C will have the same duties as B but will include the following:





+ This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to supervisor.


+ Work directly with physicians to 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 physician is the national Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; assist with literature reviews; contribute to the preparation of study abstracts, posters, manuscripts and grant applications.


+ Work in conjunction with unit managers


+ Participate in budget preparation for trials as needed. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required


+ Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the Cellular Therapy and Transplant Clinical Research Program. This includes managing various aspects of multi-center trials such as working with partnering institutions on budgets and IRB documentation, and monitoring external research sites.


+ Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (“GCP”) (e.g. scheduling subject 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, coordinating treatment administration and/or procedures with physician or NP, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).


+ Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinators/assistants who provide 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. Act as back-up to the unit managers when required.





QUALIFICATIONS:




Clinical Trials Coordinator B: Bachelor’s degree and 2-4 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple research projects; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) knowledge or experience in cancer preferred but not required; (6) ability to work flexible hours; (7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.




Clinical Trials Coordinator C: Bachelor’s degree and 4-6 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) knowledge or experience in cancer preferred but not required; (6) ability to work flexible hours; (7) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.




POSITION IS CONTINGENT UPON CONTINUED FUNDING






Job Location - City, State

Philadelphia, Pennsylvania

Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.






Department / School

Perelman School of Medicine





Pay Range

$43,919.00 - $66,183.00

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.










Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.




Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.




University Benefits

+ Health, Life, and Flexible Spending Accounts : 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.

+ Tuition : Take advantage of Penn's exceptional tuition benefits . 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.

+ Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

+ Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.

+ Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. 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.

+ Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

+ Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.

+ University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.

+ Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

+ Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.

+ Penn Home Ownership Services: 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.

+ Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection 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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