Clinical Protocol DeveloperCulmen International, LLC is hiring a Clinical Protocol Developer to assist the Naval Medical Center in Portsmouth, VA. This position will support the Department Head of CID and is accountable for research related matters to the PIs of each research protocol. Provide support to the Department Head of CID and the PI of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions.
This position is onsite in Portsmouth, VA.What You'll Do in Your New RoleAssist physicians/scientists in developing, writing, and producing human and animal research protocols in support of the military medicine research programsAssist with the preparation of investigator-initiated trials to include coordination of the protocol submission, submission of amendments and regulatory compliance reports, and the development of presentations and/or publicationsAssist with preparing informed consent statements and other study-related research documentsConduct literature reviews and draft scientific and technical documentsContribute to the preparation and modification of internal study budgetsAssist with ensuring PI-initiated protocols contain quality research design, and meet DOD standards for ethics and complianceAssist the PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), and other committee queriesAttend and assist with the planning of committee meetings for disease-specific working groups to facilitate research developmentAssist with administering the study development tracking system and updating protocol details and development events in eIRB systemWork with the data management team, clinical operations team, and other research collaborators 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 questionsAssist the clinical research coordinators in the development of specimen submission.Assist the research and statistical data coordinators, database developers, and database administrators in study database development and data monitoring planningAssist 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)Participate in the collection of data, supporting both human and animal protocols.Provide education and training to researchers and staff on protocol developmentRequired QualificationsBachelor's Degree5 Years of Clinical Research ExperienceAbility to obtain a Secret ClearanceAbout the CompanyCulmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.Exceptional Medical/Dental/Vision Insurance, premiums for employees are 100% paid by Culmen, and dependent coverage is available at a nominal rate (including same or opposite sex domestic partners)401k – Vested immediately and 4% matchLife insurance and disability paid by the companySupplemental Insurance AvailableOpportunities for Training and Continuing Education12 Paid HolidaysTo learn more about Culmen International, please visit Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants.
Our commitment to these principles is unwavering across all our operations worldwide.The determination of compensation at Culmen International, LLC is based on various factors such as location, the individual's unique combination of education, knowledge, skills, competencies, clearance level, experience, internal equity, contract-specific affordability, and organizational requirements.