UNIV-Clinical Research Coordinator I-Department of Dermatology

Job Description Summary

The Clinical Research Coordinator is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Dermatology as directed by the Principal Investigator. This position will be responsible for adhering to study guidelines, coordinating study visits, ensuring participants meet stringent clinical inclusion guidelines, provide education to patients and their families. Additionally, incumbent will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices”, and adhere to the MUSC IRB regulations for the protection of human subjects. Some travel is required.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000961 COM Dermatology CC

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

39,764.00 - 56,670.00 - 73,576.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Description:

The Clinical Research Coordinator is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Dermatology as directed by the Principal Investigator. This position will be responsible for adhering to study guidelines, coordinating study visits, ensuring participants meet stringent clinical inclusion guidelines, provide education to patients and their families. Additionally, incumbent will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices”, and adhere to the MUSC IRB regulations for the protection of human subjects. Some travel is required.

MUSC Training and Experience Requirements:

A bachelor's degree and one-year relevant program experience.

Job Duties:

30% Oversee the day-to-day operations of research protocols and supervise and manage day to day clinical operations. Ensure study-required clinical elements and tests are conducted and collected according to the protocol. Coordinates with research physicians, raters, and other study staff for timely completion of all study activities and ensures all resource areas are available for completion of study visits. Schedules study participants, caregivers, and research personnel for study visits in compliance with study protocol. Transcribes data into case report forms completely and accurately. Monitors completeness and accuracy of case report forms, and coordinates collection and filing of all source documents. Performs data entry as per study protocol.

15% Maintains subject level documentation for all studies independently. Conducts and assist with study visits and may perform research assessments. Extracts data from EPIC. Completes all required case report forms in accurately, completely, and in a timely manner. Manage data collection and data entry, reviewing documentation for accuracy and data validity as needed.

10% Act as the primary administrative point of contact for internal research staff and as the principal operational liaison for other research organizations, funding agencies and regulating bodies.

10% Independently creates regulatory submissions and annual reports to the IRB and completes required supplemental regulatory documents for all studies. Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.

10% Independently obtain and document informed consent. Maintain accurate informed consent documents for later review. Recruits study participants per study inclusion and exclusion criteria.

5% Implement corrective action plans as indicated.

5% Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA, etc. Coordinates monitoring visits and completes corrections and queries in a timely manner. Assists other study teams as needed to meet study requirements and organizational goals.

5% Review workload and operating procedures of research studies to determine priorities and workflow.

5% Serve as a liaison with ancillary services providing protocol related training as needed.

5% Travel to Sponsor initiated investigator meetings with investigators. Attend information and training sessions at investigator meetings to ensu