Clinical Research Coordinator B/C
Job Description Summary
The Clinical Research Coordinator B/C in the department of Radiation Oncology coordinates investigator-initiated and sponsored clinical trials involving radiation therapy; ensuring strict adherence to study protocols; regulatory requirements, and radiation safety standards. This role supports patient enrollment, scheduling and follow-up, data collection, and regulatory documentation while collaborating closely with the CRU team.
Position is contingent on continued funding.
This position is hybrid eligible after successful completion of intro period and 6 months of service.
Job Responsibilities
Clinical Research Coordinator B
- Coordinate trial related activities to ensure the execution of the trials adheres to the protocol and regulatory compliance; maintaining regulatory documents per sponsor requirements, University of Pennsylvania, FDA, and GCP standards and guidelines; preparing and participating study monitoring and audit visits
- Communicate with potential patients, pre-screening, scheduling, consenting, and enrolling patients; ensuring all the enrolled subjects have documented eligibility check list and signed appropriate version of consent
- Coordinate research visits; maintaining source documentation, data collection and completing CRFs; obtaining, handling, processing, transferring /shipping of biospecimens when applicable
- Track AE/SAE, maintaining documentation, and study logs; coordinating with regulatory specialist when regulatory entities report is needed, such as reportable AE/SAE deviations
- Conduct follow up phone calls to participants; includes tracking participants through the timepoints, uploading data to relevant databases; perform data QC and address queries
- Perform research billing review, subject reimbursement when applicable; documenting all trainings and essential correspondence that related to study
- Attending study related meetings and other meetings as required, maintaining/ordering study materials as needed
- Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Clinical Research Coordinator C
In addition to the above, the CRC C will work with minimal supervision from their project manager and independently manage their assigned clinical trials. The CRC-C may act in a lead capacity in coordination with CRU Research Team projects and assist Research Team Managers in overseeing the execution of project timelines as well as completion of study related activities delegated to the research coordinators(A/B) who provide study related support. May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues.
Qualifications
Clinical Research Coordinator B
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. Regulatory experience is preferred; Radiation Oncology experience is preferred but not required.
Clinical Research Coordinator C
Bachelor's degree and 4 to 6 years of experience or equivalent combination of education and experience is required. Regulatory experience is preferred; Radiation Oncology experience is preferred but not required.
The successful candidate must have strong problem-solving abilities, excellent written and verbal communication skills, and solid organizational and time management skills. They will be flexible and able to manage multiple tasks while maintaining strong attention to detail. The candidate should be capable of working both independently and as part of a team, and possess knowledge of IRB and human research protection regulations.
Position is contingent on continued funding.
This position is hybrid eligible after successful completion of intro period and 6 months of service.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$52,500.00 - $63,085.00 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.
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