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Jobs · Analyst · South Carolina

UNIV - Research Regulatory Specialist - Hollings Cancer Center

MUSC Health · Charleston, SC · 5 mo ago
On-siteAnalystFull-time

About the role

This position provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. It oversees regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center.

Responsibilities

  • Helps to oversee the study start-up process and manages the start-up timeline of all oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s).

  • 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.

  • 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.

  • 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.

  • 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.

  • Prepares 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.

  • Complete sponsor required regulatory documentation as required.

  • Create and maintain essential regulatory documents.

  • Maintain accurate and complete hard copy study files.

  • Aid with sponsor and internal monitoring visits and reviews and provides regulatory support to effectively meet the needs of monitors and auditors during site visits.

  • Promptly reviews and addresses quality assurance deficiencies noted for regulatory documentation.

Requirements

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

Qualifications

  • Ability to perform job functions in an upright position.

  • Ability to perform job functions in a seated position.

  • Ability to perform job functions while walking/mobile.

  • Ability to work indoors.

  • Ability to work outdoors in all weather and temperature extremes.

  • Ability to work in confined/cramped spaces.

  • Ability to perform job functions from kneeling positions.

  • Ability to squat and perform job functions.

  • Ability to perform 'pinching' operations.

  • Ability to fully use both hands/arms.

  • Ability to perform repetitive motions with hands/wrists/elbows and shoulders.

  • Ability to reach in all directions.

  • Possess good finger dexterity.

  • Ability to maintain tactile sensory functions.

  • Ability to lift and carry 15 lbs., unassisted.

  • Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted.

  • Ability to push/pull objects, up to 15 lbs., unassisted.

  • Ability to maintain 20/40 vision, corrected, in one eye or with both eyes.

  • Ability to see and recognize objects close at hand.

  • Ability to see and recognize objects at a distance.

  • Ability to determine distance/relationship between objects; depth perception.

  • Good peripheral vision capabilities.

  • Ability to maintain hearing acuity, with correction.

  • Ability to perform gross motor functions with frequent fine motor movements.

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