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Jobs · Analyst · South Carolina

UNIV-Research Study Coordinator - Hollings Cancer Center

MUSC Health · Charleston, SC · 1 wk ago
On-siteAnalystFull-time

About the role

The Manager of Clinical Operations coordinates, establishes, and supervises complex research protocols at the Hollings Cancer Center (HCC) to efficiently and effectively integrate cooperative group and industry-sponsored trials at the Medical University of South Carolina (MUSC).

Responsibilities

  • Coordinates patient research related activities to accurately meet protocol requirements. Ensure protocol compliance for study participants.

  • Ensures database updates to reflect accurate patient status. Utilizes office tools including Sharepoint, Clinical Data Center (CDC), and clinical trial management system (CTMS).

  • Provides protocol specific information to physicians, primary nurses, and patients. Coordinates the clinical work-up to determine patient eligibility. Coordinates treatment plan and required follow-up with study participant, medical staff, nursing staff and ancillary hospital personnel.

  • Works closely with clinical nurse staff to coordinate patient care to meet protocol standards. Consults with the investigator to assess study participant for response to protocol therapy including toxicity assessment and disease status.

  • Captures and submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC. Ensures data quality and timely completion and submission of case report forms (CRFs) and queries.

  • Prepares, transports, and handles bloodborne pathogens and other human specimens following OSHA guidelines. Enters and maintains both current and new study participant information into the clinical trials database.

  • Timely and accurately submits Adverse Events, Serious Adverse Events, and other reportable events to the NCI, sponsors, IRB and DSMC per federal guidelines and institutional policies.

  • Maintain working knowledge of disease specific trial portfolio and participate in disease focus group meetings to support trial start up process for new studies and maintenance of protocol amendments.

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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