Today
Public Trust
Mid Level Career (5+ yrs experience)
No Traveling
Healthcare and Science
Portsmouth, VA (On-Site/Office)
About the Role:
Culmen International is seeking a Clinical Protocol Developer to work on site in Portsmouth, VA at the Naval Medical Center Portsmouth.
What You'll Do in Your New Role:
Assist physicians/scientists in developing, writing, and producing human and animal research protocols in support of the military medicine research programs
Assist 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 publications
Assist with preparing informed consent statements and other study-related research documents
Conduct literature reviews and draft scientific and technical documents
Contribute to the preparation and modification of internal study budgets
Assist with ensuring PI-initiated protocols contain quality research design, and meet DOD standards for ethics and compliance
Assist the PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), and other committee queries
Attend and assist with the planning of committee meetings for disease-specific working groups to facilitate research development
Assist with administering the study development tracking system and updating protocol details and development events in eIRB system
Work 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 questions
Assist 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 planning
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)
Participate in the collection of data, supporting both human and animal protocols.
Provide education and training to researchers and staff on protocol development
Required Qualifications:
Bachelor’s Degree
Minimum five (5) years of Clinical Research experience
Ability to obtain Public Trust/NACI clearance
About the Company:
Culmen International is committed to enhancing international safety and security, strengthening homeland defense, improving global health and humanitarian programs, and optimizing government operations. With experience in over 140 countries, we help our customers to accomplish critical missions in challenging environments worldwide.
Exceptional Medical/Dental/Vision coverage with 100% of the premiums paid by the company for all employees and their eligible dependents for full-time positions (including same or opposite-sex domestic partners)
401k – Vested immediately and 4% match
Life insurance and disability paid by the company
AFLAC Available
Tuition Assistance
12 Paid Holidays
At Culmen International we are committed to creating, promoting, and sustaining a culture of diversity, equity, and inclusion. Our commitment to these values is unwavering across all our work around the world. We include and celebrate employees of diverse races, genders, religions, sexual orientations, ethnicities, nationalities, socioeconomic statuses, languages, (dis)abilities, ages, and religious commitments. These differences drive innovative solutions to meet the needs of our employees and clients. Culmen is an equal opportunity employer.
Culmen International is seeking a Clinical Protocol Developer to work on site in Portsmouth, VA at the Naval Medical Center Portsmouth.
What You'll Do in Your New Role:
Assist physicians/scientists in developing, writing, and producing human and animal research protocols in support of the military medicine research programs
Assist 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 publications
Assist with preparing informed consent statements and other study-related research documents
Conduct literature reviews and draft scientific and technical documents
Contribute to the preparation and modification of internal study budgets
Assist with ensuring PI-initiated protocols contain quality research design, and meet DOD standards for ethics and compliance
Assist the PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), and other committee queries
Attend and assist with the planning of committee meetings for disease-specific working groups to facilitate research development
Assist with administering the study development tracking system and updating protocol details and development events in eIRB system
Work 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 questions
Assist 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 planning
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)
Participate in the collection of data, supporting both human and animal protocols.
Provide education and training to researchers and staff on protocol development
Required Qualifications:
Bachelor’s Degree
Minimum five (5) years of Clinical Research experience
Ability to obtain Public Trust/NACI clearance
About the Company:
Culmen International is committed to enhancing international safety and security, strengthening homeland defense, improving global health and humanitarian programs, and optimizing government operations. With experience in over 140 countries, we help our customers to accomplish critical missions in challenging environments worldwide.
Exceptional Medical/Dental/Vision coverage with 100% of the premiums paid by the company for all employees and their eligible dependents for full-time positions (including same or opposite-sex domestic partners)
401k – Vested immediately and 4% match
Life insurance and disability paid by the company
AFLAC Available
Tuition Assistance
12 Paid Holidays
At Culmen International we are committed to creating, promoting, and sustaining a culture of diversity, equity, and inclusion. Our commitment to these values is unwavering across all our work around the world. We include and celebrate employees of diverse races, genders, religions, sexual orientations, ethnicities, nationalities, socioeconomic statuses, languages, (dis)abilities, ages, and religious commitments. These differences drive innovative solutions to meet the needs of our employees and clients. Culmen is an equal opportunity employer.
group id: 10228389
