Scientific Program Analyst
Job opening ID
Scientific Program Analyst
Roles and responsibilities
Must be a US Citizen
Some travel may be required
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking Scientific Program Analyst to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term contract position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
•Work with staff to develop and write policies within the Office of Human Subjects Re-search Protections (OHSRP), NIH Human Research Protection Program (HRPP).
•Work with staff on analyses of new and complex national and international guidelines, regulations, guidance documents; identify emerging issues that impact the protection of human subjects and communicate information to NIH officials, researchers and commit-tees, particularly to the Human Subjects Research Advisory Committee (HSRAC) and IRB-Professional Administrators Committee (I-PAC); ensure that NIH policies, procedures and practices are consistent with guidance issued by DHHS so that NIH can provide comments for proposed national policies; establish and evaluate the processes for implementation of such analysis to ensure compliance throughout the HRPP.
•Provide support for the reporting of Unanticipated Problems to the DHHS Office of Human Research Protections.
•Support OHSRP staff on evaluating and developing agreements with other institutions for the conduct of collaborative human subjects research.
•Participate in the development of educational materials for the NIH HRPP; develop materials to implement SOPs for the NIH HRPP; lead training sessions for the NIH research community.
•Participate in NIH-wide committees, taskforces and focus groups to seek input from subject matter experts; ensure that proposed policy changes encompass best practices while meeting the varied needs of the research community.
•Work with staff to promote greater compliance across institutes by engaging key stake-holders and leveraging their ability to champion regulatory/policy requirements, e.g. clinicaltrial.gov registration and reporting; prepare recommendations to the NIH DDIR and the Director, OHSRP, resulting from the work of these groups.
•Identify and collect necessary program data and conduct interviews with senior officials to obtain information for reports; assemble and assess information gathered; formulate findings, conclusions and recommendations; present results in written and/or oral form, which express the particular human subject’s issue; prepare reports.
•Evaluate the strengths and weaknesses of the NIH HRPP to enhance regulatory compliance; develop policies and procedures for the evaluation of the NIH HRPP program for the purpose of improving human subjects training and educational programs for NIH staff and IRB members.
•Work with staff to create electronic systems for NIH wide document management required for human subject’s protection regulatory compliance; perform gap analysis and define system specifications; ensure that new systems reduce barriers to communications, meet reporting requirements to regulatory bodies such as OHRP and the FDA, engage the broadest possible audience and are platform neutral.
•Provide support for the development of systems specifications that assist in eliminating barriers to compliance and resistance to change; consider use of various communication tools such as Frequently Asked Questions (FAQ) database, common terminology glossary, web-based training, and other tools to assist NIH investigators and IRB members to comply with HRPP policies and procedures; coordinate all aspects of such development projects with CIT and OIT.
•Bachelor’s degree in a related discipline.
•Minimum of one (1) year of related experience.
•Experience with Excel and spreadsheets or database development.
•Familiarity with IT (website) capabilities.
•Ability to independently manage multiple time-sensitive projects.
•Ability to multi-task and pay close attention to detail.
•Excellent judgment with the ability to determine which decision and actions require guidance from senior staff and which actions can be taken independently.
•Demonstrated interest, through work experience or undergraduate projects, in human subjects research work
•Strong communications skills, both oral and written.
•Excellent analytical, organizational and time management skills.
Number of positions