Job Description Summary
The Department of Surgery, Division of Transplant Surgery Research, is actively recruiting for a Research Program Coordinator I. The Research Program 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-05
Pay Range
38,985.00 - 55,559.50 - 72,134.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Pay Range:
$38,985.00 - $55,559.00 - $72,134.00
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%
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.
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)
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The Department of Surgery is dedicated to ensuring the voices of our trainees, staff, faculty, and patients are heard; their thoughts are respected and their feelings are valued. We pride ourselves on creating an inclusive culture dedicated to helping shape the field of surgery to be more diverse. We value our residents, fellows, faculty, and staff of every race, religion, national origin, sexual orientation, gender identity, and disability. Our goal is to continue to expand our diversity within our talented team, which leads to even more inclusive patient-centered care. Please click on the link below to learn more about our diversity efforts.
https://medicine.musc.edu/departments/surgery/diversity-and-inclusion
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.
Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
