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
