Fda Program Administrator Jobs in Mount Pleasant, SC

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

Work Shift

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, Chemistry or Physics.  One Year experience in the research field is helpful but not mandatory.  The ability to use computer word and data processing programs including but not limited to Microsoft Office and statistical analysis programs are very helpful. 

The ability to collect, organize and analyze information in a clear and concise manner is required. 

Upon completion of both Institutional Review Board (IRB ) and Brain Stimulation Laboratory ( BSL) training, this individual will need to function in an independent manner.

Supervision is available as needed. 

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