"Clinical Research Coordinator A"

Job Description Summary

Assist in the coordination of Phase I - IV clinical trials. Complete, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., case report forms and study binders) as directed by the supervisor. Conduct data entry in CRFs as provided by the study sponsor Organize study start up and generate materials to support trial workflows. Navigate eligibility criteria. Develop recruitment strategies to poise trial for success. Minimize participant burden whenever possible through; reduction of barriers to recruitment, timely responses, answering questions, ongoing feedback, and support of concerns. Serve as an overall resource or point of contact for individuals interested in clinical trials. Resolve data queries with sponsor and CROs. Ensure data monitoring accuracy. Recruit, screen and enroll potential study subjects as specified per protocol. Utilize the EMR to support and operationalize clinical research. Provide study related metrics and tracking. Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required. Process and ship blood, urine, and serum specimens for each trial. Schedule patient visits and any necessary testing. Attend Investigator Initiation meetings. Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines. Obtain records required to complete case report forms. Assist in the preparation of documents needed for initiation, monitoring and closeout visits with sponsors and/or CROs. Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, informed consent form (ICF), and FDA guidelines. Assist PI with presentations and publications

Job Responsibilities

• Assist in the coordination of Phase I - IV clinical trials
• Complete, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., case report forms and study binders) as directed by the supervisor
• Conduct data entry in CRFs as provided by the study sponsor
• Organize study start up and generate materials to support trial workflows
• Navigate eligibility criteria
• Develop recruitment strategies to poise trial for success
• Minimize participant burden whenever possible through; reduction of barriers to recruitment, timely responses, answering questions, ongoing feedback, and support of concerns
• Serve as an overall resource or point of contact for individuals interested in clinical trials
• Resolve data queries with sponsor and CROs
• Ensure data monitoring accuracy
• Recruit, screen and enroll potential study subjects as specified per protocol
• Utilize the EMR to support and operationalize clinical research
• Provide study related metrics and tracking
• Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required
• Process and ship blood, urine, and serum specimens for each trial
• Schedule patient visits and any necessary testing
• Attend Investigator Initiation meetings
• Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines
• Obtain records required to complete case report forms
• Assist in the preparation of documents needed for initiation, monitoring and closeout visits with sponsors and/or CROs
• Show vigilance in patient safety, protocol compliance, and data quality
• Adhere to all University of Pennsylvania, informed consent form (ICF), and FDA guidelines
• Assist PI with presentations and publications

Regulatory responsibilities:

• Assist in the preparation and submission of regulatory documents (including continuing reviews, amendments, and adverse event reporting) to the University of Pennsylvania Institutional Review Board (IRB)
• Assist in the preparation and processing of regulatory documentation with pharmaceutical companies and CROs
• Assist in obtaining the appropriate signatures for regulatory forms
• Organize and maintain all documentation required by sponsor or CRO
• Resolve regulatory related queries with sponsors and CROs.

Contingent Upon Funding

Qualifications

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

Preferred:

• 1- 2 years of clinical trial/clinical research experience

The successful candidate must have: Effective problem-solving skills; effective verbal and written communication skills; ability to learn new methods quickly and multi-task; demonstrated ability to work as part of a team as well as independently; ability to work flexible hours; knowledge of IRB and Human Research Protection Regulations; Experience in Microsoft word and excel.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $50,000.00 Annual Rate