"Clinical Research Coordinator B/C"

Clinical Research Coordinator B/C

Job Description Summary

The responsibilities of this position will be to provide assistance and oversight with single-center and multi-center clinical research trials conducted within the Cardiovascular Medicine Division of the University of Pennsylvania. This position will support specific specialty sections in Cardiology and will require coordinating efforts within the Division with collaborating sites and external institutions, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different interventions and varying complexities. Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.

This position is contingent upon favorable funding.

Clinical Research Coordinator B

Job Responsibilities

• Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
• Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
• Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
• Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
• With supervision, assist in preparation of research protocols and documents.
• With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
• Other duties and responsibilities as assigned

Qualifications

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Clinical Research Coordinator C

Job Responsibilities

• Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
• Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
• Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
• Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
• Work with primary investigators to develop investigator-initiated protocols, case report forms and databases. Independently design research documents including consent forms, source documents, CRFs and training SOPs.
• A CRC C will be expected to do this independently.
• Other duties and responsibilities as assigned

Qualifications

• Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

The position is contingent upon grant funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$52,500.00 - $67,046.00 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.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

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