Regulatory Affairs Specialist jobs in Charleston, SC

Job Description Summary

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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

MUSC Minimum Training and Experience Requirements:

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

MUSC 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)

Additional Job Description

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