UNIV - Research Phase I Regulatory Specialist - Hollings Cancer Center

Job Description

35% Study Start-up Reporting and Activation Project Management

Helps to oversee the study start-up process and manages the start-up timeline of all Phase 1 solid tumor and fast track oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s) (DFG).

As outlined within the NCI Cancer Center Support Grant, the aim for the average time to activation is 60 calendar days from the time of Protocol Review Committee (PRC) submission.

Responsible for timely, accurate, input of required study start-up milestones into the Clinical Trials Data System to facilitate efficient project management and metric tracking.

Maintain OnCore per policy, updating study and personnel listings and task lists. Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups.

Any trials that exceed NCI CCSG metrics will be properly escalated to the DFG leader and HCC CTO Unit managers. - Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads to ensure appropriate prioritization of essential document creation to facilitate synchronized start-up and ensure task list deadlines are met.

• Completes the protocol submission form in the Protocol Review Committee (PRC) portal to initiate the scientific review process.
• Attends the CTO Pending Projects meetings and specific DFG meetings to provide input into prioritized tasks and follows-up to ensure start-up of studies in a compliant and timely manner.
• Effectively communicates regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly.
• Provides DFG leaders relevant data on time to activation metrics and assists the leader in identifying new trends and barriers.

35% IRB Application and Document Management

Responsible for preparation, submission, outcome follow-up, documentation and communication of all IRB submissions from initial application through termination.

This includes amendments, reportable events, and annual renewals. Communicate the study status updates and ensures that the study team has valid study documents to complete tasks.

This responsibility commences at the original point of project entry and continues through IRB termination of projects. -Efficiently tracks IRB submissions by utilizing the appropriate process task lists and entering accurate submission details and status updates in the clinical trials management system.

• Collaborates with sponsors / CROs to develop informed consent documents that are compliant with MUSC policies and verifies informed consent language is accurate with appropriate MUSC departments and ancillaries.
• Determine appropriate IRB of record and type of regulatory submissions or internal documentation that are required and communicate study updates / IRB submission activity to the study team in a timely manner.

Is proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and any other IRB of record for studies assigned.

Prepare responses to IRB requests for information or study document revisions. -Organizes all study documents per policies within hard copy and electronic systems.

Communicates updates and releases IRB approved documents to investigators, sponsors, ancillary teams, and CTO accurately and timely

25% Approval Processing and Quality Assurance

• Complete sponsor required regulatory documentation as required. Initiate and maintain accurate and comprehensive documentation as required by the sponsor in compliance with all applicable federal, state and local regulations, policies and procedures and Good Clinical Practice guidelines.
• Effectively applies regulatory knowledge of federal regulation and standards, problem solving and continuous quality improvement methods in daily operations.
• Create and maintain essential regulatory documents. -May go on campus to meet with investigators and staff to obtain signatures for regulatory documents.
• Maintain accurate and complete hard copy study files -Assist with sponsor and internal monitoring visits and reviews and provides regulatory support to effectively meet the needs of monitors and auditors during site visits.
• Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor / auditor. Promptly reviews and addresses an quality assurance deficiencies noted for regulatory documentation.

5% Regulatory Unit Support and Continuing Education

• Participates in training curriculum and continuing education
• Participates in Regulatory 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 three 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

Minimum Requirements : A bachelor's degree and three 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.

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