Job Description Summary
Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core GrantEntity
Medical University of South Carolina (MUSC - Univ)Worker Type
EmployeeWorker Sub-Type
ClassifiedCost Center
CC001332 HCC CTO AdministrationPay Rate Type
HourlyPay Grade
University-05
Pay Range
Scheduled Weekly Hours
40Work Shift
Job Description
30% Regulatory submissions for reportable events, continuing renewals and local changes. Prepares submissions through IRB approval of continuing renewals, reportable events (Protocol Deviations, Internal Serious Adverse Events, External Serious Adverse Events) and locally generated amendments such as study staff or investigator changes from the point of study activation until study termination. Tracks IRB applications within OnCore by releasing and updating task lists. For continuing renewals, utilizes OnCore forms and reports to accurately track expirations dates and make continuing renewal submissions. Utilizes the CTO internal forms for reportable events, personnel and investigator changes to initiate new task lists in OnCore and initiate IRB applications. - Prepares study-specific personnel credentialing documents such as delegation logs and protocol training documents and updates Maintain OnCore per policy, updates study and personnel listings, SPARC personnel lists, and eReg. - Is proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and any other IRB of record for studies assigned. - Effectively communicates regulatory requirements within project teams and consistently enters status changes and personnel updates within 24 hours within application systems such as OnCore, eReg, SPARC and other systems.
30% Regulatory Document Management and Quality Assurance -Conducts internal quality assurance checks in preparation of external monitor visits or sponsor/FDA audits. Assures that all study documents are filed and labeled appropriately per Good Clinical Practice Guidelines. -Receives and reviews internal monitor visit letters. Files the correspondence and works with the study team to address all issues prior to the monitor/audit visit. This may include reaching out to the study and data coordinators to verify that their clinical operation findings are addressed prior to the next visit. -May provide assistance or coverage to the Pre-activation and amendment processing regulatory specialist as needed, particularly in the maintenance of the trial master file and accurate posting of study documents for the release to the team and preparation of the monitor or audit visit. -Will support the transition of trial documents from hard copy to electronic within eReg software. Will ensure that the transition of documents is completed per policy.
30% Monitor Visit Scheduling and Attendance/Support - For studies assigned within the CTO team, this role is responsible for the scheduling of monitor visits on behalf of the study team. This includes scheduling time for the regulatory, study coordination/clinical operations review and time with PI and ancillary services such as investigational drug services. -Utilizes the Study Monitor Visit request form for tracking monitor visit requests and status. -Communicates in a professional, timely and accurate manner to the sponsor, PI, ancillary services and study team. This will include the creation of study visit confirmations and agendas along with support documents to sponsor visitors
about system access instructions and directions. -Will support the request to EPIC and initiate monitor reviews within eReg. -Files all monitor visit documentation within the trial master file. This includes correspondence, agendas, sponsor letters, and site visit logs. -Review the prior monitor visit letters prior to the next visit to ensure that findings are addressed and appropriately in process.
10% Regulatory Unit Support and Continuing Education -May support data entry and reporting of quality assurance findings and participate in process improvement projects -Participates in training curriculum and continuing education training of employees -May help with training, mentorship, and process improvement projects. -Participates in Regulatory unit coverage plans as needed - Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees. Applies MUSC Standards of Behavior to all aspects the job assigned Participates in monthly regulatory meetings and other HCC CTO staff meetings and application university or HCC trainings. - Maintains effective relationships with sponsors/CROs
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.
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
Not employed or contracted at MUSC?
External Applicants, Apply Now
Are you a current employee or contractor at MUSC? Please log in to OurDay with your NetID.
Apply on Internal Careers Site
UNIV - Physical Medicine & Rehabilitation Physician-Sports Medicine - Department of Orthopaedics | CHS - College of Medicine - Orthopaedic Surgery & Physical Medicine | Instructor-Faculty | University (UNIV) | R-0000047521 | Charleston | South Carolina | United States | Charleston | University Faculty | Faculty | Job Description Summary The Department of Orthopaedics and Physical Medicine & Rehabilitation at the Medical University of South Carolina is recruiting a board certified/ board eligible Physical Medicine Sports Medicine physician. The incumbent wi... | Part Time | ||||
Certified Child Life Specialist Outpatient Radiology | CHS - CHW Foundation Funds CHS - CHW Foundation Funds | Child Life Specialist | Hospital Authority (MUHA) | R-0000047428 | North Charleston | South Carolina | United States | North Charleston | Human Services | Clinical & Research Support Services | Job Description Summary Offering an exciting opportunity as our first Outpatient Radiology Child Life Specialist. This new position, located at our pediatric ambulatory center, will provide psychosocial support to children and families receiving ... | Full Time | ||||
UNIV-Temporary Clinical Instructor, Population Focused Nursing | CHS - College of Nursing - Office of Academic Affairs | Temporary-Unclassified-Faculty | University (UNIV) | R-0000047498 | Charleston | South Carolina | United States | Charleston | University Faculty | Faculty | Job Description Summary This is a part-time temporary position as a clinical instructor needed for Fall 2025 in support of our prelicensure Population Focused Nursing course. The candidate must have demonstrated nursing clinical expertise in manag... | Part Time | ||||
UNIV– Temporary Instructor, Undergraduate Program, Health Assessment | CHS - College of Nursing - Office of Academic Affairs | Temporary-Unclassified-Faculty | University (UNIV) | R-0000047492 | Charleston | South Carolina | United States | Charleston | University Faculty | Faculty | Job Description Summary This is a part-time temporary position as a clinical instructor needed for Fall 2025 in support of our prelicensure Health Assessment course. The candidate must have demonstrated Fundamentals and Medical-Surgical nursing cl... | Part Time |
Speak directly with our employees to learn about life at MUSC
Thank you
Thank you for your interest in working at MUSC!
This website uses cookies.
We use cookies to personalize content such as job recommendations, and to analyze our traffic. You consent to our cookies if you click "I Accept". If you click on "I Do Not Accept", then we will not use cookies but you may have a deteriorated user experience. You can change your settings by clicking on the Settings link on the top right of the device