Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary

The Clinical Protocol Developer shall 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.

Responsibilities

Essential Job Functions:

• 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.