Clinical Protocol Coordinator

About this role

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 operational objectives of the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD). This position is a full-time position located in Bethesda, MD, with telework eligibility.

• Work with auditing units, nursing staff, and medical records personnel to support audits, manage audit activities, and collate audit responses.

• Conduct quality assurance activities and prepare for regulatory audits conducted by FDA, NIH, pharmaceutical sponsors, and other stakeholders.

• Provide technical support to researchers and clinic staff, including protocol coordination, patient scheduling, registration activities, and resolution of study-related inquiries.

• Coordinate with IRB administrators to collect, review, maintain, and submit regulatory documentation through the NIH Protocol Tracking and Management System.

• Independently provide support services to satisfy the overall operational objectives of NCI/DCTD.

• Prepare standard operating procedures (SOPs) related to audits and clinical research activities.

• Attend multicenter site calls and prepare detailed meeting notes and communication summaries.

• Respond to data and regulatory queries from Theradex and prepare written responses in collaboration with nursing staff and data managers.

• Assist with the preparation and maintenance of regulatory documents required for protocol approvals by FDA, CTEP, IRB, OPRR, and drug sponsors.

• Update and maintain regulatory binders and ensure the accuracy of study and regulatory records.

• Assist researchers with protocol development, review, and assembly of clinical trial documentation.

• Assist in the development of internal research proposals, abstracts, poster presentations, and manuscript drafts.

• Support the creation of protocol schemas, patient calendars, teaching aids, informed consent documents, and other ethics- and regulatory-related materials.

• Develop and maintain study-related SOPs and operational procedures.

• Collect, organize, and maintain study documentation, including investigator qualifications, trial logs, safety reports, annual reports, and correspondence.

• Write, edit, and maintain study protocols, amendments, reports, and associated regulatory submissions.

• Prepare and submit study safety reports, annual reports, amendments, and regulatory correspondence.

• Maintain data files across multiple software systems and communication platforms.

• Perform data entry, data cleanup, database queries, descriptive statistics, and basic univariate analyses.

• Coordinate recruitment, scheduling, travel, and admission of research participants with clinical staff.

• Communicate with IRB personnel and NIH Clinical Center staff regarding protocol approvals and regulatory actions.

• 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 

• Minimum of TEN (10) years of related experience supporting clinical research, clinical trials, protocol coordination, or regulatory compliance activities.

• Experience supporting clinical trials, clinical research studies, or protocol-driven research environments.

• Experience preparing, maintaining, and submitting regulatory documentation.

• Knowledge of quality assurance processes and regulatory audit preparation.

• Experience working with IRBs, FDA regulatory requirements, and clinical research compliance processes.

• Ability to anticipate research staff needs and develop alternative processes to support operational objectives.

• Ability to adapt, create, and utilize tools to analyze and evaluate projects and programs.

• Proficiency with Microsoft Office Suite.

• 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:

• Familiarity with Clinical Trial Management Systems (CTMS).

• Proficiency using Electronic Medical Record (EMR) systems.

• Strong analytical, organizational, and time management skills.

• Strong written and verbal communication skills.

• Ability to work independently and collaboratively in a multidisciplinary research environment.

• Working knowledge of Electronic Data Capture (EDC) systems.

• Background in clinical trials quality assurance and monitoring.

• Prior support for NIH, NCI, DCTD, or other federal clinical research programs.

• Ability to perform descriptive statistical analyses and manage study databases.

• Demonstrated ability to coordinate multicenter clinical research activities.

The annual salary range for this position is $130,000.00-$216,000.00. 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

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