Clinical Research Coordinator A​/B​/C

Clinical Research Coordinator A/B/C

As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states 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.

Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, Hem Onc, Endocrine, Renal and Geriatrics. To learn more about DOM CTU visit https://(Use the "Apply for this Job" box below)..

Job Description

Clinical Coordinator A:
Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit. The person will support a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Involvement in trials will range from consulting to serving as the primary coordinator for a study handling all coordinator activities such as:

• Assist in development of study documents.
• Work with Regulatory Specialist for regulatory submissions.
• Communicate with study team members.
• Recruit, consent, and screen patients according to protocol.
• Schedule patient visits and any necessary testing.
• Conduct patient visits.
• Monitor patients per protocol requirements and ensure adherence to protocol requirements.
• Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts.
• Collect, review, and report study data.
• Complete case report forms and resolve data queries.
• Process and ship study specimens including blood and urine.
• Participate in initiation, monitoring, audit, and close-out visits.
• Participate in study team meetings and ongoing protocol training.
• Assist in the development and maintenance of study specific case report forms and source document tools.
• Show vigilance in patient safety, protocol compliance, and data qualify. Adhere to all University of Pennsylvania, FDA, and GCP guidelines.

Clinical Coordinator B, in addition to the above, 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 in the management of clinical trials and will need to use more independent judgment.

Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the project manager. In addition, will develop complex documents such as protocols and consents, lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up and execute studies. Accountable for making sure study timelines and goals are met.

Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Management of clinical trials and will need to use more independent judgment.

Qualifications

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations

*** Position is contingent upon continued funding***

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$47,313.00 - $70,000.00 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.

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.

University Benefits

• Health, Life, and Flexible Spending Accounts :
  Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's…