Clinical Protocol Developer Odyssey Systems Consulting Group, Ltd. - 3.9 Portsmouth, VA Job Details Full-time $90,000 - $127,000 a year 7 hours ago Benefits Health savings account Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Project team coordination Master's degree in health science Medical writing Committee work Content creation for technical audiences Informed consent Institutional Animal Care and Use Committees (IACUCs) guidelines compliance Professional ethics Job-specific skills training (staff training program) Technical support 3 years Research project design Clinical staff training Quality assurance Data management Scientific protocols Health Science Informed consent procedures implementation QA/QC Implementing research protocols Project execution Regulatory submission editing and review Communication with regulatory authorities for clinical trials Training & development Research participation Research veterinary medicine Senior level Technical writing experience within technology Clinical research reports Research and development project management

Full Job Description Position Summary:

Odyssey is seeking a Clinical Protocol Developer to support the Clinical Investigation Department (CID) and CTRG (Combat Trauma Related Group) at the Navy Medical Center, Portsmouth (NMCP) Virginia. The mission of the command is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates. NMCP conducts biomedical research in general surgery, psychology, otolaryngology, pediatrics, nursing research, orthopedics, women's health, and emergency medicine, which are relevant to the Graduate Medical Education Program.

•Contingent upon contract award

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Responsibilities:

Duties include, but are not limited to: Provide technical and scientific support for the development and execution of investigator-initiated protocols and clinical trials at NMCP. This position will partner with the PI to fully develop an idea from the letter of intent (LOI) stage to an ethical and IRB/IACUC-compliant protocol that can be successfully executed at NMCP. Assist physicians/scientists in developing, writing and producing human and animal research protocols and nonhuman subjects' protocols NMCP CID and GME. Assist the government PIs with the preparation of new investigator-initiated trials, coordination of the submission, submission of amendments and regulatory compliance reports, and the development of the final product (presentation and/or publication), subject to final Government approval. Assist with preparing informed consent statements and other study related research documents, subject to final Government approval. Conduct literature reviews and draft scientific and technical documents, subject to final Government approval. Assist with ensuring government PI-initiated protocols contain quality research design, and meet DOD standards for ethics and compliance, subject to final Government approval. Assist with the amendment of existing investigator-initiated protocols, subject to final Government approval. Assist the government PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), and other committee queries. Assist the PI with Academic Research Competition (ARC) queries and submissions. Attend and assist with the planning of committee meetings for research specific working groups to facilitate development. Contractor shall not function as a voting member. Assist with administering the study development tracking system and updating protocol details and development events in eIRB system, subject to final Government approval. Work with the data management team, clinical operations team and other research collaborators (as required) in transitioning projects from the development team to the operations team that incorporates the clinical details needed to treat patients and the research elements to answer study questions. Assist the clinical research coordinator in the development of specimen submission. Specimen submission shall be in accordance with the Government's protocols and are in accordance with requirements and regulations for research studies and as determined by the project leaders. Specimen submission is subject to final Government approval. Assist the research and statistical data coordinators, database developers and database administrators in study database development and data monitoring planning, subject to final Government approval. Assist with collecting information on reported problems regarding consistency and/or clarity in open protocols. Assist with initial and follow-on updates of study registration on clinicaltrials.gov, including facilitation of Quality Assurance (QA) Review comments with coordination of the PIs, subject to final Government approval. Participate in the collection of data, supporting both human and animal protocols. Provide education and training to researchers and staff on protocol development within and outside department. Contractor shall not provide education and training to Government or military personnel without prior endorsement by the COR and the cognizant local Government Staff Training Manager. All education and training materials are subject to final Government approval.

•Contingent upon contract award

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Qualifications:

Minimum Required Qualifications:

Citizenship:

Must be a US citizen.

Clearance :

Ability to

Obtain Secret Education:

Masters degree in a biological, health science, physiology ,veterinary medicine, or related field.

Years of Experience:

Three years of relevant research experience.

Certifications:

N/A Additional Information Location:

620 John Paul Jones Circle, Portsmouth, VA 23708

Travel:

10%

Remote, Onsite, or Hybrid:

Onsite #LI-JC1

•Contingent upon contract award

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Company Overview:

Odyssey is a world-class technical, engineering, and integration company serving the warfighting ecosystem with airborne integration, ISR, C2, and warfighter readiness capabilities. Odyssey meets the military's operational needs by integrating layered defense systems from equipment, technology, and services to data, information, and business operations. We streamline defense acquisition and sustainment, engineering the technical battlefield with domain-specific proficiency to ensure lethality. Odyssey is dedicated to excellent contract execution, peak organizational performance, and fostering a workplace built on employee care. Odyssey is proud to live out our core values of commitment, ambition, and respect in our work and communities through OdysseyCares, a philanthropic group focused on giving back through direct donations, an employer match program, and volunteering events. Equal Opportunity Employer/Protected Veterans/Individuals with

Disabilities 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. This position is filled through continuous recruitment and will remain open until a sufficient pool of applications has been received. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, Tricare supplement, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health savings accounts, employee assistance program, learning and development benefit, paid time off, and holidays. Odyssey Benefits