Clinical Research Coordinator - Department of Internal Medicine

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Essential functions (job duties):

Position Purpose:

Coordinate and participate in clinical research studies by
performing activities involved in the collection, compilation,
documentation of research data. The position will work with
principal investigators and other research team members to
accurately and efficiently carry out a range of tasks associated
with a variety of clinical research studies.

Essential Functions:

Recruit, screen, obtain informed consent, and enroll eligible
participants according to protocol for clinical studies. Schedule
and coordinate participant’s study visits and/or work with
outpatient scheduler. Directly interact with subjects in a clinic
setting, including subject interviews, administering survey
instruments, etc., per protocol requirement.

Collect and record participants’ study-related data into electronic
and paper case report forms. Ensure all study related documentation
is completed accurately, in a timely manner, per sponsor
requirements. Ensure compliance with protocol guidelines and
regulatory agency requriements.

Collect, process, label, store, and ship bio-specimens for clinical
studies. May obtain blood samples (including blood draws),
cultures, tissues, urine, stool, nasal swabs, plasma
microbiological isolates and other specimens for laboratory
analysis and processing, depending upon on the study. Track and
monitor participants’ condition and test results during the course
of the clinical studies. Relay relevant results to the clinical
team. Perform study drug accountability, if needed, as per
protocol.

Manage all the regulatory activities and requirements relevant to
the research. Manage the collection of essential regulatory
documents and the execution of study protocol. Prepare IRB
(Intitutional Research Board) initial applications, amendments,
continuations, closures and submit electronically (ePortal for
example) as well as manually, as needed. Prepare for sponsor
monitoring visits, site initiation and closeout visits.

Assist the PrincipaI Investigator with the sponsor budget. Work
with administrative staff to ensure appropriate billing for
study-related care. Coordinate with billing department to make sure
that all the research related activities are billed to the sponsor
and paid by the sponsor. Review billing calendars and study budgets
to ensure appropriate care designations and costs for clinical
studies.

Design source documents/ generic forms for data collection,
recruitment materials, consent forms and other relevant documents
for clinical studies as required. Perform general office and
administrative duties related to clinical studies.

Participate in recruitment strategy meetings to enhance subject
awareness of studies and boost subject participation. Attend
investigator meetings and training as a study team member.

Other duties as assigned.

Unique duties:

Qualifications:

Education:

Bachelor's degree in a medical or health science discipline or
equivalent combination of education and experience.

Years of Experience Required:

Minimum one year experience working in a research or clinic
environment and interaction with study populations.

Knowledge, Skills and Abilities:

Excellent interpersonal and communication skills. Experience with
Microsoft Office products (i.e., Microsoft Word, Excel, Power
Point) and Electronic Data Entry/Capture (EDC). Excellent
multi-tasking, problem solving and record-keeping skills. Strong
ability to work independently, exercising good judgement, with
minimal supervision. Organizational and analytical and problem
solving skills. Ability to function with diverse teams of people in
a diplomatic, collaborative, and effective manner. Ability to work
independently and adhere to established timelines to accomplish
tasks. Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA
regulations. Ability to maintain data confidentiality and
participant/subject/patient privacy. Working knowledge of medical
terminology and assessment of laboratory values.

Preferred qualifications:

School/College/Division:

H06 - School of Medicine

Primary department:

H0609 - Internal Medicine

Employment type:
• Regular Employee
• Job type: Full Time
• Job category: Staff/Administrative

Funding/salary information:
• Compensation type: Annual Salary
• Hourly rate:
• Salary minimum: $56,131
• Salary hire maximum: $67,354

Working conditions:

Hospital, outpatient clinic, and office environments.

Job openings:
• Number of openings: 1
• Reposted position: No
• Reposted reason: None (New Requisition)
• Prior posting/requisition number:

Background check requirements:

University policy requires certain persons who are offered
employment to undergo a background check, including a criminal
history check, before starting work. If you are offered employment,
the university will inform you if a background check is
required.