CLINICAL RESEARCH COORDINATOR B/C

CLINICAL RESEARCH COORDINATOR B/C

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Posted Job Title

CLINICAL RESEARCH COORDINATOR B/C

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 The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC.

The Clinical and Translational Research Program for Lymphomas and Other Related Diseases ("Lymphoma Research Team") within the ACC CRU seeks a full-time Clinical Research Coordinator B/C (CRC). The successful candidate will (1) ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and other federal/institutional requirements, and (2) meet required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research nurses (CRNs).

The CRC is an integral and essential member of the ACC CRU Lymphoma Research Team. We are looking for an enthusiastic, professional, and committed team member to work closely with our investigators, team leaders, CRNs, and other research team members. The ACC received an exceptional rating from the National Cancer Institute (NCI) and is considered one of the top 10 cancer centers in the country. We are looking for a CRC that will help accelerate this momentum through the conduct of cutting-edge clinical trials.

Career Development Opportunities: The ACC is focused on career development of CRCs and offers an advanced infrastructure of leadership and training to guide and support new CRCs from initial training, to continued professional growth.

Job Description

Job Responsibilities

Clinical Research Coordinator B Responsibilities:

This individual will work under general supervision. Specific responsibilities include (but are not limited to):

• Plan, organize, and contribute to study-related meetings, including but not limited to Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits, and ongoing training sessions; maintain complete and accurate records of meetings/sessions, and ensure that resulting action items are completed in a timely manner.
• Assist with start-up processes for Industry-sponsored, Cooperative Group, and Investigator-initiated studies; proactively review protocols and associated manuals, ask questions, and pursue corrections or clarifications, if needed. Coordinate non-therapeutic studies and complex Phase I, II, or III oncology clinical trials.
• Assist the Regulatory Coordinator by preparing components of submissions (e.g., institutional forms, initial submissions, amendments, continuations, etc.) and drafting responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols.
• Lead or contribute to Informed Consent in accordance with federal and Pennsylvania state law. Review inclusion/exclusion criteria with other members of the study team and facilitate eligibility review with the Sponsor/CRO, if required.
• Provide support to faculty and staff during study-related visits. Ensure timely and appropriate documentation of visits and testing. Coordinate exception requests (or prospective deviations); document and report adverse events, serious adverse events, events of interest, and non-medical events.
• Collect, review and report timely, valid, and accurate data within the timelines specified by the study-specific Agreement; this includes resolving data discrepancies and timely response to sponsor queries; timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission. Maintain an up-to-date list of incidental (i.e., minor) deviations; coordinate reportable (i.e., major) deviations and other unexpected events.
• Coordinate independent central review of clinical trial end-points (e.g., imaging data). Transport, process and ship biological materials (e.g., blood, urine, tissue, etc.) using universal precautions. Receive and maintain central lab supplies, kits, and equipment (e.g., EKG machines, ePRO tablets, etc.). Assist with billing reconciliation, tracking site reimbursements and allocating patient stipends. May be asked to assist with research scheduling.
• Maintain complete, well-organized, and audit-ready study and participant files (e.g., subject charts, case report forms, enrollment logs, hospital records, etc.) from participant screening through final follow-up. Secure signatures and forward documents/forms (e.g., FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log.
• Participate in research meetings (e.g., team, disease-site, etc.) and Sponsor/CRO teleconferences. Provide coverage and support to meet departmental and organizational staffing needs (i.e. lunches, sick calls, vacations, or when a specific team member's workload exceeds capacity). Maintain all relevant trainings and certifications (e.g., CITI, GCP, IATA, PENN CRC Certificate, Penn Profiler trainings, etc.). Make use of available resources and established procedures to identify problems ideally before they happen.
• Perform other duties as reasonably assigned.

Clinical Research Coordinator C Responsibilities:

The CRC C will work independently under minimal supervision and may act in a lead capacity or as back-up to the Supervisor, which includes oversight of the study team and serving as the point-of-contact for some day-to-day situations. The CRC C responsibilities will be the same as B but will include the following:

• Plan, organize, and run study-related meetings, including but not limited to Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits and ongoing training sessions.
• Take a lead role in Site Feasibility and Qualification Visits; work in conjunction with the Unit Managers to initiate start-up processes for industry-sponsored and Investigator-initiated trials; independently manage the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials inclusive of managing multi-site projects where Penn is the lead site.
• Prepare components of submissions to the IRB (and other entities) and remain aware of the regulatory statuses for assigned protocols; may be asked to draft or edit study protocols and associated documents (e.g., informed consent, manuals of procedures, etc.).
• Participate in the development of study-specific Case Report Forms and other data collection tools; may be asked to contribute to study reports, abstracts, posters, manuscripts, and grant applications.
• Participate in Sponsor teleconferences, Program meetings, and working groups that will maximize the efficiency and quality of research performed; may be responsible for orientation/mentorship of new staff and act as a resource to current staff members with study-related issues; provide coverage and support to other Coordinators to meet departmental/organizational staffing needs.
• Assist the Unit Managers with QA processes related to research studies; take a lead role in preparing for any inspection (e.g. internal and external audits) that takes place with the trials, as required.

Position may involve some work-related responsibilities that may occur outside of usual hours and some conference-related travel. Position is contingent on continued funding.

QUALIFICATIONS

Clinical Research Coordinator B: Bachelor's degree and 2-3 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 lymphomas or other related diseases 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 Research 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 lymphomas or other related diseases 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

$52,500.00 - $64,000.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.