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UNIV- Regulatory Assistant- Hollings Cancer Center

Apply now Job no: 519372
Entity: MUSC University
Department: ACADEMIC AFFAIRS - Hollings Cancer Center
Sub Department: UNIV-2101020-HCC Clinical Trials Office
Work type: Full-Time
Employee Type: UNIV - Classified
Location: Charleston, SC
Categories: ADMINISTRATIVE & NON-CLINICAL PROFESSIONALS
Pay scale: UNIV-Band 4: $27,527.00 - $39,228.00 - $50,930.00 (min - mid - max)

Job Duties:
15Provides general office support as needed: Regular signature/mail runs to Hollings CTO and other departments on main campus; Answers the telephone; Sorts and maintains office supplies; Assist in organizing patient/protocol materials for off-site storage and retrieval of those records as needed; Troubleshoot computer requests and questions to appropriate area; Provides administrative support for quality assurance initiatives and tracking systems; Runs reports for meetings and data collection, as neededEssential
25Assists in facilitating pre-activation study activities: Enter new CTO#s in the CTMS as directed by the Regulatory Manager; Initiate sponsor contact and communicate site information and requirements; Create new electronic and hard copy study binders; Facilitate sponsor document processing with appropriate MUSC departments; Maintain current status entries in the CTO tracking system; Attend Pending Projects meetingsEssential
25Facilitate the scheduling and assist in the preparation for quality assurance and control programs such as audits and sponsor monitor visits: Manage the monitor site visit calendar; Schedule the monitor visit with MUSC ancillaries; Prepare site visit agendas; Serve as primary contact for monitor site visits; Help prepare the regulatory filing and regulatory documents are up to date and accurate in the CTO and Sponsor binders; Track site visit follow-up letters and ensures all action items are addressed prior to the next site visit; Assist the Program Regulatory Specialist as needed while monitors are on-siteEssential
30IRB Approval Processing, Communication, and Study Document Management: Enters IRB approval notices and manages study documents housed in the e-Research Database and Hollings Cancer Center website; Submits protocol approvals to study sponsors, MUSC study team and ancillaries; Updates study document postings; Organizes and files hard copy/electronic study regulatory documents in protocol binders or electronic drive; This includes manages the filing records of external SAE reports that don’t meet IRB reportability criteria;-Ensures data entered to the e-Research database is accurate and timely; Organizes and files hard copy/electronic study regulatory documents in protocol binders or electronic drive; Ensures documents are properly filed and maintained following data entry policiesEssential
5Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees.Essential


Job summary:Serves as program assistant for the administrative offices of the Hollings Cancer Center Clinical Trials Office


Payscale Salary Range: UNIV-Band 4: $27,527.00 - $39,228.00 - $50,930.00 (min - mid - max)


FLSA: Hourly


Minimum Experience and Training Requirements: A high school diploma and two years relevant program experience. A bachelor's degree may be substituted for the required program experience.


Physical Requirements: 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. (Continuous) 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 20/20 vision, corrected. (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 hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

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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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.