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UNIV - Clinical Research Coordinator - Department of Medicine: Division of Pulmonary

MUSC Health · Charleston, SC · 3 mo ago
On-siteAnalystFull-time

About the role

The Senior Clinical Research Coordinator is responsible for the day-to-day coordination, management, and execution of complex clinical research studies in accordance with Good Clinical Practice (GCP), institutional policies, and federal regulations.

Responsibilities

  • Advanced Visit Coordination & Study Execution: Independently coordinate assigned research protocols and oversee the clinical and operational activities required for successful study execution. Responsibilities include screening and enrolling participants; obtaining informed consent; coordinating and conducting study visits per protocol; educating participants and families/caregivers; monitoring and reporting adverse events, including preparation of serious adverse event reports; collecting and processing laboratory specimens; dispensing or coordinating investigational product as applicable; reviewing patient diaries; entering data; completing case report forms; and maintaining accurate, organized, and compliant study documentation.

  • Recruitment, Disease-Specific Workflow & Enrollment Strategy: Support disease-specific research meetings and workflows to help identify target populations, raise awareness of active trials, and meet study enrollment goals. Partner with investigators and program leadership to review inclusion/exclusion criteria, support participant identification, and develop practical workflows within disease populations to improve recruitment, screening, enrollment, and retention.

  • Data Management & Database Support: Independently maintain accurate and complete subject-level documentation for assigned studies. Coordinate data management activities according to protocol requirements, regulatory standards, and institutional policies. Responsibilities include collecting, recording, abstracting, and submitting study data within required timelines; supporting database design, implementation, updates, and integrity review; extracting data from Epic or other approved systems; retrieving outside medical records when appropriate; maintaining complete case files; and responding to data queries promptly.

  • Specialized Clinical Procedures, Investigational Product & Specimen Management: Perform or coordinate protocol-required clinical procedures and specimen-related activities that require training or certification, which may include phlebotomy, sweat testing, spirometry, EKG, laboratory collection and processing, specimen preparation, shipping, and inventory tracking. Support investigational product handling, dispensing coordination, accountability, and documentation at the protocol and subject level in accordance with the pharmacy manual, protocol requirements, and institutional policy.

  • Sponsor, Monitor & Audit Readiness: Prepare for and support sponsor monitoring visits, internal audits, FDA or regulatory inspections, site initiation visits, closeout visits, and other study review activities as required. Ensure monitors and auditors have appropriate access to study documents, source data, regulatory materials, databases, workspace, and other resources. Communicate findings, requests, and responses to the PI and program leadership, and support timely resolution of queries, deficiencies, or follow-up items.

  • Communication, Team Leadership, Training & Mentoring: Prepare for and participate in study, program, disease-specific, sponsor, and team meetings. Serve as a knowledgeable point of contact between sponsors, PIs, vendors, subcontractors, ancillary services, Investigational Drug Services Pharmacy, labs, imaging, NEXUS, MUSC Hospital services, and other partners. Mentor and assist with training junior staff as needed, including shadowing opportunities, equipment/process training, and reinforcement of protocol-specific expectations.

Qualifications

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

Physical Requirements

  • 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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