Program Research Coordinator - MUSC

Job Description SummaryCome join our innovated research team at MUSC Catawba Division.EntityMedical University Hospital Authority (MUHA)Worker TypeEmployeeWorker Sub-Type​RegularCost CenterCC004382 LAN - Clinical Trials (LMC)Pay Rate Typ...

Job Description Summary

Come join our innovated research team at MUSC Catawba Division.

Entity

Medical University Hospital Authority (MUHA)

Worker Type

Employee

Worker Sub-Type​

Regular

Cost Center

CC004382 LAN - Clinical Trials (LMC)

Pay Rate Type

Salary

Pay Grade

Health-23

Scheduled Weekly Hours

40

Work Shift

Day (United States of America)

Job Description

Under general supervision of the Clinical Trials Manager coordinates and supervises complex data management activities involving protocol management, patient follow-up, and data management core support for research studies. Coordination and management of industry-sponsored which this position will be involved. Include basic and investigator initiated clinical trials information about research population, the complexity involving devices and drugs for human subjects and of the study. The coordinator will manage multiple studies involving subject screening, and enrollment, scheduling visits, and conducting follow-up visits. Monitoring all study participants to ensure institutional and Internal Review Board (IRB) compliance. The coordinator works directly with patients, staff, and Principal investigators to ensure that the integrity of the study is maintained. Responsible for research data collection, regulatory documents, maintaining screening and subject logs, and reporting adverse events and protocol deviations to appropriate agencies.

Responsibilities:

• 35%- Coordinate all phases of clinical trials and regulatory management with limited supervision (i.e., study start-up/initial submission, enrollment, study visit completion, data entry, query resolution, annual renewals, amendment processing, and closeout activities).

• 35%-Coordinate proper data management according to protocol requirements and protocol compliance, i.e. collect and record all data about study patients on specific (funded or unfunded) studies and submit on time to research bases. Maintain up-to-date knowledge of the status of current studies. Review, evaluate, and report to PI monthly, as to the status of each study.

• 10%- Liaison between the patient and the PI regarding consent forms for patient enrollment and for scheduling of treatments in conjunction with protocol timelines. Collaborate with all members of the research team in developing and implementing strategies for the effective management of the research studies. Coordinate with nurses, tech, and other hospital ancillary services requirements for the successful study milestones. Implement recruitment and enrollment strategy for the division. Collaborate with other sub-sites in enrollment productivity and assist the Program Manager in handling multicenter trials.

• 10%- Act as liaison between sponsors/clinical research organizations, local IRB faculty/staff, and study site personnel; Serve as a departmental resource for site personnel and Principal Investigators; Interact effectively and professionally at all levels mentioned above.

• 5%- Perform quality assurance/audit of study documentation/files before IRB audit/external sponsor monitor review. Maintain critical regulatory binders required for site documentation.

• 5%-Perform other duties and special projects as needed

Experience/Skills/Knowledge:

• Detail-oriented with a high level of accuracy

• Ability to exercise judgment and discretion

• Ability to effectively communicate, both written and verbally

• Excellent interpersonal skills

• Professional demeanor

• Incumbent must have a proven track record of detail-orientation and a high level of accuracy. Must be fluent in using computer data management software, such as Microsoft Office.

Additional Job Description

Minimum Education: A bachelor's degree and one year of relevant program experience

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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