Job Description Summary

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Research Grant

Cost Center

CC001064 COM SCTR Operations CC

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

Work Shift

Job Description

Job Description:

Serve as a Research Coordinator providing technical and professional services within the SCTR’s Research Nexus Research Coordination and Management (RCM) fee for service component. The position will assist Principal Investigators (PI) involved in the coordination of human subject activities as delegated by the PI. Responsibilities may include the recruitment of study participants, scheduling study visits, data collection, conducting research assessments and managing and maintaining up to date regulatory files.

Job Duties:

1). Research Operations-Study Visits 35%

Independently develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment.
Screens participants for all studies independently, maintains subject level documentation for all studies independently, may train others on Good Clinical Practice Guidelines related to study documentation.
Conducts study visits and may perform complex research assessments, extracts complex data from electronic medical records and may train others on protocol specific testing/interviews,
Conducts and/or documents consent for participants in a variety of studies independently applying knowledge of human subject’s protection regulations in the informed consent process.

2). Research Operations- Regulatory 20%

Acts as a regulatory authority or advisor, or trains and/or educates others and/or advises research teams on regulatory matters, may manage multi-site regulatory documents independently.
Creates regulatory submissions and annual reports to regulatory authorities and funding agencies (NIH, FDA, etc.) and completes required supplemental regulatory documents (IND/IDE, Certificate of Confidentiality, etc.) for all studies and trains other staff in these tasks. Acts as a liaison for multi-site studies, managing regulatory submissions and reporting across all participating sites and with the IRB of record.

3). Research Operations Administrative- 10%

Assists with management and tracking of Investigational Products (IP) at the protocol and subject level employing required systems for handling, dispensing, and documenting IP for investigator-initiated protocols.
Collects, prepares, ships, and/or maintains inventory of research specimens and provides guidance on system improvements related to specimen handling.
Corrects audit/monitor findings independently.
Collects, prepares, or processes adverse event information independently
Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
Reviews study participant charges, identifies discrepancies and escalates to appropriate offices to ensure billing compliance.

4). Data and Informatics- 10%

Completes case report forms and enters data into EDC systems(s). Resolves data queries.
Creates complex data collection forms (CRFs and/or source documents) accordingly to protocol. Exports data to include simple data analysis, and/or reporting of data.

5). Site and Study Management 10%

Makes recommendations to investigators and oversight organizations regarding site resources, recruitment, and budget feasibility for a clinical trial.
Develops study protocol specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Ensures study teams are compliant with institutional requirements/policies. Provides training to staff around these policies and ensures appropriate study specific training plans per the Delegation of Authority Logs.

6). Ethics and Participant Safety 5%

Coordinates efforts and data for external monitoring boards and independently facilitates and submits the completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest.
Employs safeguards for human subject protection and/or ensures vulnerable population regulations are adhered to and mitigated.
Proactively identifies potential problems and risks to the participant, study investigator, research team, and institution and implements conflict management plans per regulations and institutional policies.

7). Leadership and Professionalism 5%

Identifies research barriers and takes part in a committee, taskforce, or ad hoc group to address. Develops tools to disseminate to other research teams.

8). Communication and Team Science and Other Duties as Required 5%

Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, labs, imaging, NEXUS, and MUSC Hospital services.
Other duties as required.

Additional Job Description

Minimum Requirements: A bachelor's degree and two 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. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

UNIV - Research Program Coordinator I - Journeyman - Department of SCTR

About the role