Washington, District of Columbia, United States · On-site
$26/hr–$29/hr
Mid level$4M raised
Job DetailsLevel: ExperiencedJob Location: US Government Accountability Office (GAO) - Washington, DC 20548Position Type: Full TimeEducation Level: High School Diploma/GED or EquivalentSalary Range: $26.00 - $29.00 Hourl…
Skills: Records Management, Electronic Document Management Systems, SharePoint, Microsoft Office Suite, Records Inventory
Job DetailsLevel: ExperiencedJob Location: National Institutes of Health - Research Triangle Park NIEHS - Research Triangle Park, NC 27709Position Type: Part TimeEducation Level: Ph.D.Salary Range: $60.00 - $85.00 Hourly…
Skills: Regulatory Compliance, Human Subjects Research, Policy Writing, Auditing, Medical Writing
Job DetailsLevel: ExperiencedPosition Type: Full TimeEducation Level: Ph.D.Salary Range: $120,000.00 - $160,000.00 Salary/yearJob Shift: DayJob Category: Public HealthPosition Objective: Provide support services as a Dat…
Skills: Database Administration, Data Management, Statistical Analysis, Image Processing, SQL
Job DetailsLevel: ExperiencedPosition Type: Full TimeEducation Level: High School Diploma/GED or EquivalentTravel Percentage: NoneJob Category: Human ResourcesPosition Objective: As a Junior Human Resource Specialist, ap…
Skills: Personnel Processing, Payroll Administration, Federal HR Compliance, Classification, Recruitment
Job DetailsLevel: ExperiencedPosition Type: Full TimeEducation Level: High School Diploma/GED or EquivalentTravel Percentage: NoneJob Category: Human ResourcesPosition Objective: As a Junior Human Resource Specialist, ap…
Job DetailsLevel: ExperiencedPosition Type: Full TimeEducation Level: High School Diploma/GED or EquivalentTravel Percentage: NoneJob Category: Human ResourcesPosition Objective: As a Junior Human Resource Specialist, ap…
Job DetailsLevel: ExperiencedJob Location: National Institutes of Health - Research Triangle Park NIEHS - Research Triangle Park, NC 27709Position Type: Full TimeEducation Level: Ph.D.Salary Range: $10,000.00 - $155,000.…
Skills: Institutional Review Board (IRB), Human Subjects Research Protection, 45 CFR 46, Regulatory Compliance, Policy Writing
Montgomery County, Maryland, United States · On-site
$50k–$65k/yr
Senior+$4M raised
Job DetailsLevel: ExperiencedJob Location: National Institutes of Health (NIH) - Main Campus/Bethesda - Bethesda, MD 20892Position Type: Full TimeEducation Level: High School Diploma/GED or EquivalentSalary Range: $50,00…
Skills: Inventory Management, Mail Services, Asset Tracking, Regulatory Compliance, MS Office Suite
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$125k–$185k/yr
Full-time
postgraduate degree, professional certificate
Posted 21d ago
~40 hrs/week
Responsibilities
The Clinical Program Manager provides comprehensive oversight of clinical research portfolios, ensuring coordination between investigators, regulatory agencies, and stakeholders. Key duties include managing project timelines, monitoring regulatory compliance, and overseeing financial performance and resource allocation.
Requirements
Candidates must hold a Master's degree in Health and Medical Administrative Services, Nursing, or a similar field. Required certifications include SOCRA, PMP, FAC-P/M, or FAC-COR, along with experience supporting NIH or federally funded research programs.
Full job description
Job DetailsLevel: ExperiencedJob Location: National Institutes of Health (NIH) - Main Campus/Bethesda - Bethesda, MD 20892Position Type: Full TimeEducation Level: Masters DegreeSalary Range: $125,000.00 - $185,000.00 Salary/yearTravel Percentage: NoneJob Shift: DayJob Category: Public HealthPosition Objective: Provide services as a Clinical Program Manager in support of the overall functions of National Cancer Institute within the National Institutes of Health (NIH).
The Clinical Program Manager shall provide personnel capable of supporting complex clinical research portfolios and ensuring efficient coordination among investigators, research teams, oversight offices, regulatory agencies, collaborating institutions, and other stakeholders involved in the conduct of clinical research.
Duties and Responsibilities
Provide comprehensive management and oversight of assigned clinical research portfolios Develop and maintain project management plans for clinical research projects Monitor project schedules, timelines, deliverables, dependencies, and milestones. Track portfolio performance metrics and report progress to leadership Assist Branch Chiefs and Program Leadership in prioritization of research activities. Support portfolio planning and resource allocation efforts Monitor project execution to ensure alignment with organizational objectives. Lead development and maintenance of project-specific work plans Coordinate project initiation, planning, execution, monitoring, and closeout activities Facilitate project meetings and maintain meeting documentation Track action items and follow-up activities Monitor project performance and identify potential barriers to success Assist investigators and research teams in achieving project objectives Develop risk mitigation and response plans Monitor identified risks throughout the project lifecycle Escalate significant issues to leadership as appropriate Coordinate corrective actions and resolution activities Identify operational, regulatory, financial, and programmatic risks Monitor and coordinate activities associated with: Protocol development; Protocol amendments; Institutional Review Board (IRB) submissions; Regulatory submissions; Continuing reviews; Study activation activities; Clinical trial monitoring activities Support preparation for audits, inspections, and monitoring visits Coordinate activities among investigators, regulatory staff, data managers, and clinical teams Monitor compliance-related milestones and deliverables Facilitate timely submission of required regulatory documents Coordinate operational activities for clinical studies 1 Assist with feasibility assessments for proposed clinical trials 2 Support startup activities for new studies 3 Coordinate participating sites for multi-center trials 4 Monitor study progress and enrollment-related metrics 5 Facilitate communication among study stakeholders Assist with development of project-specific budgets Monitor expenditures and financial performance. Track project funding and resource utilization Develop financial forecasts Identify potential budgetary concerns and recommend corrective actions. Prepare financial status reports for leadership review Serve as liaison between assigned research programs and: Office of the Clinical Director (OCD); NCI Technology Transfer Center; Regulatory offices; Collaborating institutions; Industry partners; Other NIH and NCI organizations Facilitate communication among project stakeholders Coordinate leadership briefings and status updates Prepare communication materials and project summaries Assist Government personnel with development of Statements of Work Assist with technical evaluations and acquisition planning activities Track contractor performance, deliverables, and invoice status Monitor contract milestones and option periods Support COR activities as requested Support strategic planning initiatives Analyze program performance and operational effectiveness Develop recommendations for process improvements Assist leadership with prioritization of future research initiatives Support implementation of organizational best practices. Monthly Activity Report – Monthly Portfolio Status Report – Monthly
Risk Management Report Monthly
Financial Status Report Monthly
Regulatory Tracking Report Monthly
Strategic Planning Support Reports
Annual Program Summary Report
Yearly Final Contract Summary Report
QualificationsBasic Qualifications
Master’s Degree in Health and Medical Administrative Servies, Nursing, or similar field of study. Required certifications/licenses: SOCRA Certification, FAC-P/M Certification, FAC-COR Certification, PMP Certification, Association of Clinical Research Professionals (ACRP) Experience with clinical trial management systems and research databases Experience with technology transfer agreements, clinical trial agreements, cooperative research and development agreements, or related research partnerships Experience supporting NIH, NCI, academic medical centers, or federally funded research programs
Preferred Qualifications
Ability to communicate effectively, orally and in writing, with non-technical and technical staff Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at [email protected]. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.
This position is contingent upon contract award.
Related keywords
Clinical Program ManagerNational Cancer InstituteNIHSOCRAFAC-P/MFAC-CORPMPACRPClinical Trial Management SystemsIRBProtocol AmendmentsTechnology Transfer AgreementsCooperative Research and Development AgreementsClinical ResearchPublic HealthPortfolio Management
Serve our customers to promote and protect the health and security of our nation
Industry
Business Consulting and Services
Company size
501-1,000 employees
Founded
1999
Headquarters
Herndon, VA
LinkedIn followers
27,843
Total funding
$4M
GAP Solutions, Inc. is a mission support solutions provider that partners with federal civilian and defense agencies to deliver comprehensive, professional, and specialized consulting services.
Established in 1999, GAP Solutions has experienced years of continuous growth and success by focusing on the quality of service to our clients and emphasizing employee satisfaction programs. Our corporate headquarters is located in Herndon, VA. We have successfully grown to over 800 employees across the United States.
GAP Solutions is a trusted partner to our customers. The strength of our reputation is founded on our ability to define, tailor, and deliver resources to our customers. Our primary focus on human capital resources and ability to identify and deliver the right personnel for every task is the foundation of our success.
We celebrate being awarded consecutive Top Workplaces since 2021. GAP Solutions believes that close involvement from management leadership is necessary for building long-lasting partnerships with our customers and motivating employees to actively participate in collaboration efforts. GAP Solutions is committed to fulfilling our service commitments and has earned a reputation for delivering service excellence.
GAP Solutions’ experience spans a variety of federal agencies’ missions, including the Department of Health and Human Services, the Department of Defense, the Department of State, and the Department of Homeland Security, among others. GAP Solutions provides services under five major service areas: 1) Emergency Management; 2) Security and Information Management; 3) Process Management; 4) Human Capital, and 5) Scientific Research, Analysis, and Policy Development.
GAP Solutions has been certified ISO 9001:2015 for our Quality Management System (QMS) since March 2022.
Visit our website at www.gapsi.com to contact us or for more information about our company.
Offices: 205 Van Buren Street, Suite 205, Herndon, VA 20170, US
Public HealthSecurity and Information ManagementProcess ManagementInformation Technology ServicesScientific ResearchAnalysisand Policy Developmentand Emergency ManagementElectronicsHardware
Serve our customers to promote and protect the health and security of our nation
Industry
Business Consulting and Services
Company size
501-1,000 employees
Founded
1999
Headquarters
Herndon, VA
LinkedIn followers
27,843
Total funding
$4M
GAP Solutions, Inc. is a mission support solutions provider that partners with federal civilian and defense agencies to deliver comprehensive, professional, and specialized consulting services.
Established in 1999, GAP Solutions has experienced years of continuous growth and success by focusing on the quality of service to our clients and emphasizing employee satisfaction programs. Our corporate headquarters is located in Herndon, VA. We have successfully grown to over 800 employees across the United States.
GAP Solutions is a trusted partner to our customers. The strength of our reputation is founded on our ability to define, tailor, and deliver resources to our customers. Our primary focus on human capital resources and ability to identify and deliver the right personnel for every task is the foundation of our success.
We celebrate being awarded consecutive Top Workplaces since 2021. GAP Solutions believes that close involvement from management leadership is necessary for building long-lasting partnerships with our customers and motivating employees to actively participate in collaboration efforts. GAP Solutions is committed to fulfilling our service commitments and has earned a reputation for delivering service excellence.
GAP Solutions’ experience spans a variety of federal agencies’ missions, including the Department of Health and Human Services, the Department of Defense, the Department of State, and the Department of Homeland Security, among others. GAP Solutions provides services under five major service areas: 1) Emergency Management; 2) Security and Information Management; 3) Process Management; 4) Human Capital, and 5) Scientific Research, Analysis, and Policy Development.
GAP Solutions has been certified ISO 9001:2015 for our Quality Management System (QMS) since March 2022.
Visit our website at www.gapsi.com to contact us or for more information about our company.
Offices: 205 Van Buren Street, Suite 205, Herndon, VA 20170, US
Public HealthSecurity and Information ManagementProcess ManagementInformation Technology ServicesScientific ResearchAnalysisand Policy Developmentand Emergency ManagementElectronicsHardware