UNIV - Research Program Coordinator I - Surgery: Transplant Surgery Research

MUSC Health; Charleston (SC); On-site; USD 45,000 - 77,000; Full time

Job summary

Medical University of South Carolina (MUSC) seeks a Research Program Coordinator I to oversee all aspects of clinical drug and device trials, data management, and disease registries for the Department of Surgery under the Principal Investigator.

This role ensures compliance with FDA CFRs, Good Clinical Practices, and MUSC IRB regulations, coordinates with study staff, and supports monitoring, regulatory submissions, and informed consent processes.

Qualifications

• Bachelor's degree and two years of relevant program experience.
• Knowledge of FDA CFRs and GCPs preferred.
• Experience coordinating clinical trials and IRB submissions.

Responsibilities

• Maintain subject documentation and assist with study visits.
• Extract data and complete case report forms accurately.
• Coordinate regulatory submissions and annual IRB reports.
• Obtain and document informed consent for participants.
• Prepare for monitor/audit visits and address queries.
• Support logistics for participant visits and sponsor meetings.

Skills

Regulatory submissions

Data coordination

IRB coordination

Study scheduling

Communication

Education

Bachelor's degree

Tools

EPIC

Job description

Job Description Summary

The Department of Surgery, division of Clinical Trials, is actively recruiting for a Research Program Coordinator I. The Clinical Research Coordinator is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Surgery as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices", and adhere to the MUSC IRB regulations for the protection of human subjects.

Job Description Summary

The Department of Surgery, division of Clinical Trials, is actively recruiting for a Research Program Coordinator I. The Clinical Research Coordinator is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Surgery as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices", and adhere to the MUSC IRB regulations for the protection of human subjects.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Research Grant

Cost Center

CC001066 COM SURG Administration CC

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Pay Range:

$45,300 - $61,100 - $77,000

Job Duties

• 25% - Maintains subject level documentation for all studies independently. Conducts and assist with study visits and may perform research assessments. Extracts data from EPIC. Completes all required case report forms in accurately, completely, and in a timely manner. Ensure study-required clinical elements and tests are conducted and collected according to the protocol. Coordinates with research physicians, raters, and other study staff for timely completion of all study activities and ensures all resource areas are available for completion of study visits.
• 20% - Supervise and manage day to day clinical trial operations. Schedules study participants, caregivers, and research personnel for study visits in compliance with study protocol. Transcribes data into case report forms completely and accurately. Monitors completeness and accuracy of case report forms, and coordinates collection and filing of all source documents. Performs data entry as per study protocol.
• 15% - Independently creates regulatory submissions and annual reports to the IRB and completes required supplemental regulatory documents for all studies. Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
• 15% - Independently obtain and document informed consent. Maintain accurate informed consent documents for later review. Recruits study participants per study inclusion and exclusion criteria.
• 15% - Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA, etc. Coordinates monitoring visits and completes corrections and queries in a timely manner. Assists other study teams as needed to meet study requirements and organizational goals.
• 10% - On-call responsibilities on a rotational basis with others in the department. Will be a resource for all clinical needs and available to answer study related questions or talk with patients about study participation. Travel to Sponsor initiated investigator meetings with investigators. Attend information and training sessions at investigator meetings to ensure compliance with study protocol requirements.

Preferred Skills

Works independently with minimal supervision. Must exercise judgment and discretion. Establish and maintain effective working relationships. Must be able to communicate effectively.

Additional Job Description

Minimum Requirements

A bachelor's degree and two years of relevant program experience.

Physical Requirements

(Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)

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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