Clinical Protocol Coordinator

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.

About the role

• 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.

Requirements

• 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. Candidates with an active public trust or suitability are preferred.

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.

Pay

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.

Benefits

• 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