Clinical Protocol Coordinator

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
• 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.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.