Clinical Protocol Coordinator

Guidehouse•Bethesda, MD

4d•Hybrid

About The Position

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. The role involves supporting audits, managing audit activities, and collating audit responses by working with auditing units, nursing staff, and medical records personnel. It also includes conducting quality assurance activities and preparing for regulatory audits conducted by FDA, NIH, pharmaceutical sponsors, and other stakeholders. The position provides technical support to researchers and clinic staff, including protocol coordination, patient scheduling, registration activities, and resolution of study-related inquiries. Coordination with IRB administrators is required for collecting, reviewing, maintaining, and submitting regulatory documentation through the NIH Protocol Tracking and Management System. The role independently provides support services to satisfy the overall operational objectives of NCI/DCTD. Responsibilities include preparing standard operating procedures (SOPs) related to audits and clinical research activities, attending multicenter site calls and preparing detailed meeting notes and communication summaries, and responding to data and regulatory queries from Theradex by preparing written responses in collaboration with nursing staff and data managers. Assistance is provided with the preparation and maintenance of regulatory documents required for protocol approvals by FDA, CTEP, IRB, OPRR, and drug sponsors, and updating and maintaining regulatory binders to ensure the accuracy of study and regulatory records. Researchers are assisted with protocol development, review, and assembly of clinical trial documentation, as well as in the development of internal research proposals, abstracts, poster presentations, and manuscript drafts. Support is given to the creation of protocol schemas, patient calendars, teaching aids, informed consent documents, and other ethics- and regulatory-related materials. The role involves developing and maintaining study-related SOPs and operational procedures, collecting, organizing, and maintaining study documentation, including investigator qualifications, trial logs, safety reports, annual reports, and correspondence. Writing, editing, and maintaining study protocols, amendments, reports, and associated regulatory submissions are key duties, as is preparing and submitting study safety reports, annual reports, amendments, and regulatory correspondence. Data files are maintained across multiple software systems and communication platforms. Data entry, data cleanup, database queries, descriptive statistics, and basic univariate analyses are performed. Recruitment, scheduling, travel, and admission of research participants are coordinated with clinical staff. Communication with IRB personnel and NIH Clinical Center staff regarding protocol approvals and regulatory actions is essential.

Requirements

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.

Nice To Haves

Candidates with an active public trust or suitability are preferred.
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.

Responsibilities

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.

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.)
Position may be eligible for a discretionary variable incentive bonus