Clinical Protocol Coordinator

Job Family:

Travel Required:

Clearance Required:

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.

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

About Guidehouse

Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

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