Clinical Research Coordinator - Department of Obstetrics & Gynecology

Wayne State University•Detroit, MI

1d•Onsite

About The Position

Wayne State University is searching for an experienced Clinical Research Coordinator in the Department of Obstetrics & Gynecology at its Detroit campus location. This role is crucial for coordinating and participating in clinical research studies, involving the collection, compilation, and documentation of research data. The coordinator will work closely with principal investigators and research team members to execute various tasks for clinical research studies efficiently and accurately.

Requirements

Bachelor's degree in a medical or health science discipline or equivalent combination of education and experience.
Minimum one year experience working in a research or clinic environment and interaction with study populations.
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.

Nice To Haves

Familiarity with clinical research study budgets and budgeting processes.
Experience assisting with or supporting clinical study budget negotiations.
Experience assisting with or supporting the negotiation and administration of clinical research contracts.
Familiarity with clinical research studies and protocols.

Responsibilities

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 requirements.
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 (Institutional 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 Principal 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.
Assist with the development, review, and management of budgets for clinical research studies.
Assist with clinical study budget negotiations and the contract negotiation process in coordination with appropriate University personnel.
Review clinical research protocols and related study documents to identify study requirements and associated budgetary and operational needs.
Assist with communication and coordination among investigators, study sponsors, and University offices regarding clinical study budgets and contracts.