Odyssey Systems is recruiting for a Clinical Research Coordinator (CRC) to provide support, facilitate and coordinate daily clinical research activities and guidance on the administration of the compliance, financial, personnel and related tasks of the clinical studies. Knowledge of human and animal subject research regulations and federal guidance documents is required. Work is completed in accordance with the processes and procedures that ensure compliance with federal regulations, DoD Instructions, and institutional policies relative to research at Keesler Medical Center (KMC).

***Contingent upon contract award***

Duties include, but not limited to:

• The CRC shall assist Principal Investigators (PIs) with the following in accordance with Federal, DoD and Air Force research guidelines:
• Identify appropriate forms and processes necessary to initiate, conduct and complete research protocols.
• Refine specific aims, research hypotheses and/or objectives of the proposed study.
• Coordinate statistical and scientific consultation from the CRL staff.
• Develop individualized timelines for protocols.
• Complete necessary documents for approval, including the informed consent, recruitment materials, and data collection forms.
• Coordinate administrative, IRB (Institutional Review Board), and/or IACUC (Institutional Animal Care and Use Committee) approval of proposed research protocols.
• Review new research applications in support of human and/or animal clinical investigations/research and other related research requirements to help ensure consistency, completeness, and compliance with federal and state regulations as well as institutional guidelines prior to Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) review.
• Work with Principal Investigators (PIs) to ensure that research applications are complete.
• Communicate to PIs items requiring clarification, or documents required for submission, prior to IRB review.
• Review Informed Consent Documents (ICDs) for protocol and amendment‐specific content and help ensure presence of federally mandated elements of informed consent.
• Provide guidance to administration and researchers for all DoD human and animal research regulatory issues.
• Assist with ethics and legal reviews of research applications for exempt and non‐exempt review.
• Assist with initial administrative review of Collaborative Research and Development Agreements (CRADA).
• Support preparation of IRB and/or IACUC agendas, meeting minutes and other human and/or protection‐related duties as required.
• The CRC shall assist KMC staff with coordinating assigned research studies in accordance with Federal, DoD and Air Force research guidelines while promoting the safety and confidentiality of research subjects and their data at all times:
• Ensure study materials, equipment and/or research animals are ordered for the research protocol and in accordance with CRL policies.
• Maintain complete and accurate drug and equipment accountability at all times.
• Advertise the study and recruit participants.
• Meet with potential research subjects to explain the research project in detail and enroll eligible subjects into the study by obtaining written informed consent.
• Schedule subjects for research appointment(s) or schedule operating room time.
• Maintain a master calendar for the study, and serve as point of contact for research subjects.
• Identify delays and other shortcomings in meeting objectives and develop a contingency plan as required.
• Administer surveys or questionnaires.
• Deliver specimens to internal laboratory and/or ship specimens to a referral laboratory.
• Collect required research data elements from paper or electronic patient records or other existing documents or files, in accordance with an approved research protocol and enter these data in the spreadsheets, databases, and/or statistics software.
• Work with the primary investigator and/or statistician to refine and prepare data sets for analysis.
• Coordinate the submission of research protocol amendments, progress reports, and final report to the study sponsor, the IRB and/or IACUC.
• Immediately report any adverse events to the Medical Monitor or Data Safety Monitoring Board, sponsor and the IRB and/or IACUC.
• The CRC shall provide administrative support for the management of clinical operations as necessary:
• Assist with IRB and/or IACUC agenda and minutes preparation.
• Maintain electronic and paper files of research protocols in accordance with regulatory requirements.
• Maintain a status directory of research projects led by Graduate Medical Education (GME) residents and faculty.
• Coordinate administrative tasks (scheduling, room reservations, etc.) to support research and training programs.
• Support and coordinate internal and external audits of all human and/or animal research projects.
• Provide guidance and direction for any internal audits of human and/or animal research studies to ensure all appropriate regulations are followed.
• Coordinate and support any external audits of human and/or animal research projects.
• Facilitate periodic audits of all IRB and/or IACUC‐approved research studies, and ensure findings are appropriately documented and any deficiencies adequately addressed.
• The CRC shall perform the following additional functions, as needed:
• Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.
• Attend meetings, seminars, workshops and conferences (as budget will allow) in order to gain insight into new trends in human and/or animal subject research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of increasingly sophisticated technology.
• Participate in, or present at, research‐related education sessions.
• Attend meetings, prepare meeting minutes, and be part of Cancer Committee and other Committees as needed.
• Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
• Assist with training and orientation tasks of new CRL members.
• Other duties as assigned by management.

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Education: Bachelor’s Degree from an accredited college or university 

Years’ experience: 

• Minimum of 2 years of experience as a Clinical Research Coordinator within the past five years
• Minimum of 2 years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience.
• Knowledge of human and animal subject research regulations and federal guidance documents is required.

Preferred Qualifications:

• Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
• Prior experience with a military medical agency

Additional Information:

Location: Work is on-site at the Keesler Medical Center in Biloxi, MS

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Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities