Job Description Summary
This position will serve as the Regulatory Coordinator for the Clinical Trial Research Program specializing in Pulmonary, Critical Care, Gastroenterology, Endocrinology Nephrology and Hepatology. This position will work with the Program’s Clinical Research Coordinators and Clinical Research Program Manager to ensure all deadlines are met. Responsibilities include coordinating and performing study specific regulatory processes for the Program while ensuring that appropriate regulations and Standard Operating Procedures (SOPs) are followed.Entity
Medical University of South Carolina (MUSC - Univ)Worker Type
EmployeeWorker Sub-Type
Research GrantCost Center
CC000974 COM DOM PULM General CCPay Rate Type
HourlyPay Grade
University-GEN08
Pay Range
Scheduled Weekly Hours
40Work Shift
Day (United States of America)Job Description
Job Duties:
25% - Study Start-up and Maintenance: Receive start-up packet from sponsor; initiate and monitor study start-up activities, including all necessary documents. Upon activation, submit amendments and any changes to the study to the IRB and notify study team of all approvals. Submit continuing reviews. Answer questions and provide documents as requested by the Investigator, Program Manager, and study sponsor. Maintains accurate study registration as applicable (ClinicalTrials.gov, etc) for all investigator-initiated projects; provides guidance on issues such as when to re-consent subjects, when to report events per IRB policy.
20% - Regulatory Documentation: Maintain all necessary regulatory documents, such as CVs, medical licensure, note-to-files, conflict of interest, laboratory certifications, and any other documents required for the Program’s regulatory files. Will be responsible for building electronic regulatory binders and maintaining the electronic files. Oversee regulatory documentation for multi-site projects, with MUSC acting as the lead site; responsible for creating the templates that will be utilized.
20% - Source Documentation: Create and maintain eSource documentation database for use by research coordinators. Will be responsible for maintaining database for the life of the study from creation to closure. This includes coding and building of source structure, field editing based on protocol amendments or usage needs, creating reports and alerts as needed, and alerting study team of any changes made.
15% - Study monitoring and audit visits: Ensure all documents are complete and filed (either physically or electronically) in the regulatory binder. Works with the study monitor to ensure that all action items are resolved in a timely manner. Reviews corrective action plans with the Regulatory Manager to ensure any items are addressed. Responsible for being familiar and working with any CIRBs used by the Program. Will be expected to stay current on their processes and application changes that the CIRB may have; maintains CIRB polices at the site level for reference.
10% - Administrative: Will provide administrative support as needed to the Program Manager, Accountant Fiscal Manager, Education & Operations Specialist, Accountant/Fiscal Analyst, and Regulatory Manager. Examples include, scheduling meetings, providing assistance to any Program events, completing site tours, and other tasks as needed.
5% - Safety Reporting: Completes IRB and/or sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
5% - Other: Assist with other study tasks or projects as needed.
Additional Job Description
Minimum Requirements: A bachelor's degree and one year 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.
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
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