Clinical Trials Coordinator B (Cancer Center Dept.)

Job description

Job location: Perelman Center for Adv Medicine


Employment Type: Full-time
Posted data: 2020-10-06
Req: JR00025290
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Clinical Trials Coordinator B (Cancer Center Dept.)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors Coordinators and Research Assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials. Adheres to all University and other regulatory guidelines.

This position is contingent upon funding.

Job Description

Clinical Trials Coordinator B:

This individual will work under general supervision.

Assist unit managers 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 Pancreas 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; 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 Pancreas 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

Qualifications


Pancreas 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 solid cancers 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

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$42,953.00 - $77,315.00

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.

 

 

 

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Job No:
Posted: 10/8/2020
Application Due: 1/6/2021
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