Job Family:Clinical Trial Operations
Travel Required:None
Clearance Required:Ability to Obtain Public Trust
What You Will Do:We are looking for a Clinical Protocol Coordinator to support the oversight and management of clinical trials and large-scale epidemiological studies for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a full-time position located in Bethesda, Maryland.
- Work with senior scientists in the Division of Diabetes, Endocrinology and Metabolic Diseases (DEM) on the oversight and management of clinical trials and large-scale epidemiological studies.
- Prepare documentation and procedures for clinical trial management and Data and Safety Monitoring Board (DSMB) activities.
- Review, analyze, and critique clinical trial and DSMB documentation and recommend revisions to ensure regulatory compliance.
- Draft, review, and update clinical trial management policies, procedures, and guidance documents.
- Prepare concise directives, templates, and tools to support consistent documentation and information collection.
- Prepare and maintain Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) submissions.
- Prepare IND annual reports and coordinate submissions to the Food and Drug Administration (FDA) and other regulatory agencies as required.
- Ensure all reportable Serious Adverse Events (SAEs) are reported to regulatory authorities in accordance with applicable requirements.
- Coordinate updates related to study protocols, informed consent forms, investigators, and regulatory documentation.
- Coordinate with data coordinating centers and support Program Officials in the management of DSMBs and Scientific Advisory Committees (SACs).
- Establish and maintain electronic databases to archive study protocols, DSMB/SAC documentation, meeting minutes, policies, and related records.
- Coordinate meetings, develop agendas, generate meeting minutes, and track action items.
- Develop presentations, reports, correspondence, and website content related to clinical trial oversight activities.
- Support interactions with the Office of Technology Development and Transfer and external collaborators regarding Clinical Trial Agreements, Material Transfer Agreements, and Cooperative Research and Development Agreements.
- Assist in the development and modification of study protocols, informed consent documents, and regulatory documentation.
- Support international site clearance activities and ongoing project budget monitoring.
- Coordinate communications with NIH Institutes and Centers, clinical sites, coordinating centers, and oversight organizations.
- Ensure timely archiving of biologic specimens and clinical trial data and support registration and maintenance of studies on ClinicalTrials.gov.
- Review Data and Safety Monitoring Plans (DSMPs) and Safety Officer documentation prior to funding clearance.
- Develop, review, and maintain study protocols, SOPs, informed consents, research proposals, abstracts, posters, manuscripts, amendments, audits, annual reports, and regulatory submissions.
- Maintain study records, protocol applications, safety reports, correspondence, investigator qualifications, study logs, and regulatory files.
- Track protocol approvals, study requests, adverse events, and regulatory milestones throughout the protocol lifecycle from study initiation through closure.
- Maintain master subject lists, enrollment records, and study databases.
- Provide training and guidance to investigators and staff regarding protocol submission requirements, research procedures, and regulatory standards.
- Coordinate quality assurance activities with regulatory agencies and research stakeholders.
- Support protocol coordination activities and clinic operations as needed.
- Incumbent capture, no other candidates were considered due to incumbent candidate identified. They meet the labor category requirements provided by the customer.
What You Will Need:- Master's degree in Biology, Life Sciences, Health and Medical Administrative Services, or a related field.
- Minimum of TEN (10) years of experience in clinical trials oversight, clinical research administration, regulatory affairs, or a related field.
- Background coordinating multi-center Phase I, Phase II, and Phase III clinical trials.
- Ability to prepare and maintain FDA regulatory submissions, including IND and IDE applications.
- Skill in preparing IND annual reports and regulatory correspondence.
- Familiarity with reviewing informed consent documents and supporting Institutional Review Board (IRB) submissions.
- Experience working with Data and Safety Monitoring Boards (DSMBs) and clinical trial oversight processes.
- Demonstrated technical writing experience related to clinical trials and regulatory documentation.
- Proficiency with Microsoft Office Suite.
- Ability to manage, track, and report regulatory activities through the full protocol lifecycle.
- Ability to work effectively with investigators, regulatory agencies, coordinating centers, and government stakeholders.
- Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.
What Would Be Nice To Have:- Background in human islet transplantation clinical trials.
- Knowledge of study design considerations, informed consent requirements, and regulatory requirements for transplantation research.
- Ability to close clinical trial sites upon study completion.
- Familiarity with supporting international clinical research sites.
- Skill in managing biologic specimen archiving and repository coordination.
- Exposure to Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), and Clinical Trial Agreements (CTAs).
- Ability to develop clinical research training programs or mentor research staff.
- Prior support for NIH-funded clinical research programs.
The annual salary range for this position is $149,000.00-$248,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
What We Offer:Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:
- Medical, Rx, Dental & Vision Insurance
- Personal and Family Sick Time & Company Paid Holidays
- Parental Leave
- 401(k) Retirement Plan
- Group Term Life and Travel Assistance
- Voluntary Life and AD&D Insurance
- Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
- Transit and Parking Commuter Benefits
- Short-Term & Long-Term Disability
- Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
- Employee Referral Program
- Corporate Sponsored Events & Community Outreach
- Care.com annual membership
- Employee Assistance Program
- Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
- Position may be eligible for a discretionary variable incentive bonus
