Clinical Protocol Coordinator

<p><b><u>Job Family</u>:</b></p>Clinical Trial Operations<p><br/><b><u>Travel Required</u>:</b></p>None<p><br/><b><u>Clearance Required</u>:</b></p>Ability to Obtain Public Trust<p></p><p><b><u>What You Will Do:</u></b></p><p></p><p></p><p>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.</p><p></p><ul><li><p>Work with auditing units, nursing staff, and medical records personnel to support audits, manage audit activities, and collate audit responses.</p></li><li><p>Conduct quality assurance activities and prepare for regulatory audits conducted by FDA, NIH, pharmaceutical sponsors, and other stakeholders.</p></li><li><p>Provide technical support to researchers and clinic staff, including protocol coordination, patient scheduling, registration activities, and resolution of study-related inquiries.</p></li><li><p>Coordinate with IRB administrators to collect, review, maintain, and submit regulatory documentation through the NIH Protocol Tracking and Management System.</p></li><li><p>Independently provide support services to satisfy the overall operational objectives of NCI/DCTD.</p></li><li><p>Prepare standard operating procedures (SOPs) related to audits and clinical research activities.</p></li><li><p>Attend multicenter site calls and prepare detailed meeting notes and communication summaries.</p></li><li><p>Respond to data and regulatory queries from Theradex and prepare written responses in collaboration with nursing staff and data managers.</p></li><li><p>Assist with the preparation and maintenance of regulatory documents required for protocol approvals by FDA, CTEP, IRB, OPRR, and drug sponsors.</p></li><li><p>Update and maintain regulatory binders and ensure the accuracy of study and regulatory records.</p></li><li><p>Assist researchers with protocol development, review, and assembly of clinical trial documentation.</p></li><li><p>Assist in the development of internal research proposals, abstracts, poster presentations, and manuscript drafts.</p></li><li><p>Support the creation of protocol schemas, patient calendars, teaching aids, informed consent documents, and other ethics- and regulatory-related materials.</p></li><li><p>Develop and maintain study-related SOPs and operational procedures.</p></li><li><p>Collect, organize, and maintain study documentation, including investigator qualifications, trial logs, safety reports, annual reports, and correspondence.</p></li><li><p>Write, edit, and maintain study protocols, amendments, reports, and associated regulatory submissions.</p></li><li><p>Prepare and submit study safety reports, annual reports, amendments, and regulatory correspondence.</p></li><li><p>Maintain data files across multiple software systems and communication platforms.</p></li><li><p>Perform data entry, data cleanup, database queries, descriptive statistics, and basic univariate analyses.</p></li><li><p>Coordinate recruitment, scheduling, travel, and admission of research participants with clinical staff.</p></li><li><p>Communicate with IRB personnel and NIH Clinical Center staff regarding protocol approvals and regulatory actions.</p></li><li><p>Incumbent capture, no other candidates were considered due to incumbent candidate identified. They meet the labor category requirements provided by the customer.</p></li></ul><p></p><p><b><u>What You Will Need:</u></b></p><p></p><ul><li><p>Master’s degree </p></li><li><p>Minimum of TEN (10) years of related experience supporting clinical research, clinical trials, protocol coordination, or regulatory compliance activities.</p></li><li><p>Experience supporting clinical trials, clinical research studies, or protocol-driven research environments.</p></li><li><p>Experience preparing, maintaining, and submitting regulatory documentation.</p></li><li><p>Knowledge of quality assurance processes and regulatory audit preparation.</p></li><li><p>Experience working with IRBs, FDA regulatory requirements, and clinical research compliance processes.</p></li><li><p>Ability to anticipate research staff needs and develop alternative processes to support operational objectives.</p></li><li><p>Ability to adapt, create, and utilize tools to analyze and evaluate projects and programs.</p></li><li><p>Proficiency with Microsoft Office Suite.</p></li><li><p>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.</p></li></ul><p></p><p><b><u>What Would Be Nice To Have:</u></b></p><p></p><ul><li><p>Familiarity with Clinical Trial Management Systems (CTMS).</p></li><li><p>Proficiency using Electronic Medical Record (EMR) systems.</p></li><li><p>Strong analytical, organizational, and time manage