Clinical Protocol Coordinator

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🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $149k - $248k / year

⏰ Full Time

🟠 Senior

🔴 Lead

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Guidehouse

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2018

🏥 Healthcare

🎖️ Defense

📦 Logistics

💰 Grant on 2023-02

Healthcare • Defense • Logistics

Guidehouse is a global consultancy offering advisory, digital, and managed services across commercial and public sectors. It is purpose-built to support industries such as national security, financial services, healthcare, energy, and infrastructure. Guidehouse collaborates with leaders to navigate complexity and drives transformational changes that impact the future. Their expertise spans data analytics, digital technologies, risk management, and more, with a strong emphasis on sustainability and innovation.

📋 Description

• Support oversight and management of clinical trials and large-scale epidemiological studies for NIDDK • Prepare documentation and procedures for clinical trial management and DSMB activities • Review and critique clinical trial and DSMB documentation and recommend revisions for regulatory compliance • Draft and maintain clinical trial management policies, procedures, guidance documents, directives, templates, and tools • Prepare and maintain IND applications, IDE submissions, IND annual reports, and regulatory correspondence • Coordinate FDA and other regulatory submissions and ensure reportable SAEs are reported • Coordinate updates to study protocols, informed consent forms, investigators, and regulatory documentation • Coordinate with data coordinating centers and support DSMBs and Scientific Advisory Committees • Establish and maintain electronic databases and study archives • Coordinate meetings, develop agendas, generate minutes, and track action items • Develop presentations, reports, correspondence, and website content • Support agreements and interactions with technology transfer offices and external collaborators • Support protocol development, international site clearance, budget monitoring, and communications with NIH stakeholders and research sites • Ensure timely archiving of biologic specimens and clinical trial data and maintain ClinicalTrials.gov registrations • Review DSMPs and Safety Officer documentation before funding clearance • Maintain study records, regulatory files, enrollment records, subject lists, and study databases • Track approvals, study requests, adverse events, and regulatory milestones throughout the protocol lifecycle • Provide training and guidance on protocol submissions, research procedures, and regulatory standards • Coordinate quality assurance activities and support protocol coordination and clinic operations

🎯 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 informed consent documents and IRB submissions • Experience working with Data and Safety Monitoring Boards 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; approved adjudication is required before onboarding • Active public trust or suitability preferred • Knowledge of study design, informed consent, and regulatory requirements for transplantation research • Familiarity with international clinical research sites • Skill in biologic specimen archiving and repository coordination • Exposure to CRADAs, MTAs, and CTAs • Ability to develop clinical research training programs or mentor research staff • Prior support for NIH-funded clinical research programs

🏖️ 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.) • Flexible benefits package • Position may be eligible for a discretionary variable incentive bonus