"Clinical Research Coordinator A/B"

Job Description Summary

The Clinical Research Coordinator A/B 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 upon funding.
This position is hybrid eligible after successful completion of intro period and 6 months of service.

Job Responsibilities

Clinical Research Coordinator A

• Coordinating trial related activities to ensure the execution of the trials is adherence 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
• Communicating with potential patients, Pre-screening, scheduling, consenting, and enrolling patients; Making sure all the enrolled subjects have documented eligibility check list and signed appropriate version of consent
• Coordinating research visits; Maintaining source documentation, Data collection and Completing CRFs; Obtaining, handling, processing, transferring /shipping of biospecimens when applicable
• Tracking 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
• Performing 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
• Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
• Other duties and responsibilities as assigned

Clinical Research Coordinator B

In addition to above, the CRC-B will develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start-up activities. The CRC B will have less supervision from their project manager in the management of their assigned clinical trials and will need to use more independent judgment. They 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) 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.

Note that the CRC A works under direct supervision from their manager while the CRC B works under limited supervision.

Qualifications

Clinical Research Coordinator A

• Bachelor of Science and 1 to 2 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 B

• Bachelor's degree required and 2-3 years of related experience or equivalent combination of education and experience. Regulatory experience is preferred; Radiation Oncology experience is preferred but not required.

The successful candidate must have:

• effective problem-solving abilities
• effective communication and writing skills
• strong organizational and time management skills
• be flexible and able to multi-task
• strong attention to detail
• ability to work as part of a team, as well as independently
• knowledge of IRB and human research protection regulations
• demonstrates high reliability and a good work ethic

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

$46,500.00 - $52,661.00 Annual Rate