- 29-Mar-2021 to Until Filled (EST)
- Pensacola, FL, USA
- Full Time
The McConnell Group, Inc. (TMG) is seeking a Research Assistant to support human clinical trials on-site at the Family Medicine Residency Clinic at Eglin Air Force Base, Fl. The full-time Research Assistant will provide clinical research support to include, but not limited to, recruitment, randomization, data collection, tracking, interviews, and follow-up necessary to conduct research studies in accordance with approved protocols and applicable Air Force, DoD, Department of Veterans Affairs and Federal Regulations while promoting the safety, welfare, and confidentiality of research subjects and ensuring the integrity of data at all times. This position requires a favorable background check and occupational health requirements. This position is contingent upon a contract award to TMG.
1. Provide administrative support to the Clinical Investigation Program to include the collection, compilation, transcription and documentation of research data, in accordance with the details outlined in the research protocol for a given study.
2. Coordinate administrative and Institutional Review Board approval of proposed research protocols, protocol amendments, progress reports, and final reports.
3. Ensure appropriate maintenance and renewal of human subject research protection training and other research required trainings for each individual listed on research protocol and maintain current curriculum vitae or resumes in accordance with individual Institutional Review Board policies.
4. Advertise the assigned studies utilizing the approved recruitment materials. Draft new recruitment materials and identify new avenues for recruitment as needed.
5. Create and maintain a database of research projects. Prepare reports to be presented at scheduled Clinical Investigation Program department meetings.
6. Meet with potential research subjects, explain the research project in detail, and recruit eligible subjects into the study by obtaining written informed consent and HIPAA authorization.
7. Serve as point of contact for research subjects; schedule research visits, operating room/clinic room time and other services where needed.
8. Ensure study materials and equipment are ordered and maintain accountability logs at all times.
9. Coordinate with study auditors, regulatory agencies, collaborators, and sponsors in the management of research studies.
10. Monitor research subjects' progress to include documentation and reporting of adverse events to the Medical Monitor or Data Safety and Monitoring Board, sponsor, and the Institutional Review Board. Recommend corrective action as appropriate.
11. Develop study timeline and milestones, identify delays and other shortcomings in meeting objectives and study recruitment goals, develop a contingency plan as needed.
12. Obtain research data through interviews with research subjects, administer surveys and questionnaires, and extract information from paper or electronic records, in accordance with approved research protocols. Maintain the integrity of data within data collection tools, spreadsheets and databases.
13. Assure compliance of general and study-specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with the details outlined in: research protocols, applicable Standard Operating Procedures, Food and Drug Administration regulations, Air Force Instructions, DoD Directives, MDG Instructions, Department of Veterans Affairs regulations, Institutional Review Board (IRB) specific regulations, Office for Human Subject Research Protections, The Declaration of Helsinki, The Belmont Report, National Institutes of Health (NIH) guidance and Good Clinical Practices.
14. Develop and maintain all required Agreements to include, but not limited to, Cooperative Research and Development Agreements (CRADAs) and Memorandums of Understanding (MOUs) related to assigned research protocols.
15. Perform light duties and other related duties as required and requested.
16. Maintain a safe workplace; observes appropriate safety and occupational health rules and regulations. The employee is required to attend safety and other training relative to his/her position and report infractions of safety procedures to the facility Safety Officer.
17. Draft written monthly status reports and submit to the TMG Program Manager by the first of each month.
1. Able to read, write, and speak English fluently in order to effectively communicate with all personnel eligible for medical care and the staff. Contract employees shall have the ability to enunciate with sufficient clarity to be readily understood by patients and sufficient initiative, interpersonal relationship skills and social sensitivity such that they can relate constructively to a variety of patients and staff from diverse backgrounds.
2. Excellent time management and communication skills; able to work in a team environment and concurrently support several active clinical research projects.
3. Proficient with office equipment (e.g., computers, multiline telephone system, voicemail, facsimile, copier, printers), as well as business software for word processing, presentations, spreadsheets, database management, and email communications. This includes, but is not limited to, Microsoft Office (i.e., Word, Excel, PowerPoint, and Outlook).
1. Bachelor's Degree preferred or 4 years healthcare-related field experience.
2. Must obtain Human Subject Research Protection training.
3. Must have current Basic Life Support (BLS) certification or obtain upon hire
4. Certification in Clinical Research preferred or 2 years clinical research experience in human research, development, test, and evaluation (within the last five years).
5. Experience working within the Military Medical system (e.g., as military, civilian employee or government contractor) preferred.
6. Must be detail-oriented and able to work independently following a brief period of specific technical training.
7. Available to travel in order to provide services, receive specialized training, and/or coordinate between research sites when it's in the best interest of the Government.
TMG offers competitive pay and benefits packages including health insurance; paid holiday, vacation, and PTO; EAP; 401(k) and College Savings Plan.
The McConnell Group is an equal opportunity employer EOE M/F/Disabled/Vet