UNIV - Research Program Coordinator - Psychiatry: BMed

musc; Charleston (SC); On-site; USD 45,000 - 61,000; Full time

Job summary

Medical University of South Carolina (MUSC - Univ) in Charleston, SC seeks a Research Staff member to support Bio-Behavioral Medicine research protocols. You will assist with recruitment, screening, data collection, and documentation in line with FDA and GCP guidelines.

The role includes coordinating visits, consent, and conducting study procedures in the sleep lab and MRI settings, with an emphasis on data integrity and timely reporting.

Responsibilities

• Assist with recruitment and screening of research participants, including development of advertising materials and coordination with researchers.
• Obtain informed consent, enroll participants, conduct visits per protocol, coordinate and schedule visits with clinical staff, and maintain data per protocol.
• Perform overnight shifts in the sleep laboratory and monitor participants.
• Attend study meetings and prepare progress updates for principal investigators and staff.
• Initiate and maintain FDA/IRB/compliance documentation for trials in line with Good Clinical Practice.
• Coordinate data management per protocol, manage databases, and ensure data integrity and timely submission.
• Manage study materials and maintain stock and reordering as needed.
• Conduct laboratory procedures including quantitative sensory testing, MRI, and other protocols, with training and education for staff.
• Occasionally schedule visits outside regular hours to accommodate subjects and imaging facilities.
• Coordinate sponsor monitoring visits and lab scheduling for subject and provider appointments.
• Assist in updating COVID procedures, participant screening, data collection, sanitation, PPE, and remote work measures as needed.

Job description

Job Description Summary

This position is assigned to the BioBehavioral Medicine Division for the purpose of assisting, coordinating, planning and implementing research protocols. This includes but is not limited to subject recruitment, testing, sample selections, data recording (etc.) in human research.

Additional duties include initiating and maintaining documentation as required by FDA, Institutional Review board, study sponsors, and Good Clinical Practice Guidelines in connection with research trials, training course participants and new staff in tDCS and pain testing techniques, troubleshooting, maintaining, and rewiring tDCS units, and conforming to current best practices in COVID prevention including screening, cleanliness, and social distance.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Research Grant

Cost Center

CC001042 COM PSYCH Bio-Behavioral Medicine CC

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

40

Job Description

FLSA: Hourly

Work Schedule: Monday - Friday, 8:30 am - 5:00 pm, Four overnight shifts required per month

Job Duties

• 10% - Assist with the recruitment and phone screening of research participants, including the development of new advertising materials, meeting with and calling potential participants, distribution of advertising materials and collaborating with relevant provides and researchers.
• 20% - Obtain informed consent, enroll study patients, conduct study visits as per protocol, coordinate patient visits, provide education to subjects. Implement study protocol with enrolled patients, schedule patient visits, coordinate and schedule visits with clinical staff, record pertinent data required per protocol. Administer experimental clinical treatment to enrolled patients as written in the protocol. Maintain communication with enrolled patients throughout duration of participation in clinical trial.
• 5% - Perform 4 overnight shifts per month, monitoring participants in our research sleep laboratory.
• 5% - Attend regular meetings with the study PI's to present updates and progress of the study. Record and prepare up to date information on the progress of the study for the PI's. Attend weekly staff meetings and other lab meetings as requested.
• 10% - Initiate and maintain accurate and comprehensive documentation as required by FDA, Institutional Review Board, study sponsors and Good Clinical Practice Guidelines in connection with research trials.
• 15% - Coordinate proper data management according to protocol requirements and compliance, i.e., collect and record all data pertaining to study patients on the specific study and submit on time to research bases. Provide database support (design, implement, update and review for integrity). Conduct data retrieval from large databases for data reporting and analyses. Enter data into a computerized database and manage ongoing organization of patient data files. Complete case report forms and maintain all study documents properly in compliance with both MUSC and VA standards.
• 5% - Manage the distribution, secure storage, maintenance and reacquisition of all study materials sent home with participants. Maintain adequate stock of non-reusable study materials and ensure the proper reordering of diminishing supplies.
• 10% - Conduct laboratory procedures, which can include (but not limited to) the following: quantitative sensory testing (QST) for pain, biomechanical assessments, transcranial magnetic stimulation, and MRI scanning, including following protocols, developing site specific standard operating procedures (SOPs), as needed. Once trained and competent in these procedures, provide education and training on these protocols and technologies as requested. Troubleshoot, maintain, and repair study equipment as appropriate. Coordinate repair or replacement of study equipment beyond expertise.
• 5% - Conduct study visits before and after regular work hours when necessary to accommodate the schedules of the subjects, MRI availability, surgery scheduling, or other scheduling necessities.
• 10% - Schedule and participate in all sponsor monitoring visits to review study protocols and collected data. Maintain Lab Schedule as needed. Coordinate subject and provider scheduling, including psychologist, physician, and physical therapist, as needed.
• 5% - Assist in the development and maintenance of proper and up to date COVID procedures including screening participants, developing and implementing socially distanced methods of data collection where appropriate, sanitation procedures, PPE standards, social distancing in the lab when necessary, working from home when possible, daily self-monitoring (including weekends), and all other measures required by MUSC, the VA, the CDC, and local and federal law.

Preferred Education & Training

A bachelor's degree in Biology, Psychology Biomedical Engineering, or Electrical Engineering, Math,