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Clinical Research Coordinator III
2 months ago
Candidates must be able to travel locally to other research sites several times per week. Other locations include Fairfax, VA, Reston, VA and Frederick, MD.
Under the guidance of the Clinical Trial Manager, the Clinical Research Coordinator (CRC) III functions independently and proficiently with minimal oversight and is responsible for the complete coordination of assigned clinical research activities of all phases and all levels of complexity, including investigator-initiated or other high profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and supports less experienced staff. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.
EducationBachelor's degree required, or allied health or related professional degree and equivalent work experience required Experience Experience as a clinical research coordinator in the clinical research field required 3-4 years Clinical research or related experience required Research and/or work experiences that demonstrate aptitude for research facilitation required Knowledge, Skills, and AbilitiesExcellent verbal and written communication skills.Strong communication and organizational skills.Proficient computer skills.Oversees, prepares, submits and maintains all regulatory submissions (e.g., new studies, annual review, amendments) accurately and within a timely manner; periodically self-audits records to ensure audit-readiness; ensures the appropriate delegation of study related tasks (i.e., Delegation of Authority).Possesses basic understanding of clinical trial endpoints and analytical ability sufficient to evaluate data.Oversees the informed consent process and reviews consent form with research participants and provides time for research participant to consider study participation; executes the informed consent process according to Good Clinical Practices (GCPs), procedures and other applicable rules, regulations and policies; educates new staff and research participates about protocol expectations and the conduct of clinical trials.Ensures all research participant encounters are updated as appropriate and within one (1) business day in a recognized electronic system/database (e.g., Clinical Trial Management System CTMS; enter data into various auditable databases or electronic data-capture systems (e.g., REDCap); oversees data entry and validation to ensure accuracy and completeness of the data collection process; supports data management process for clinical research projects, including addressing data queries and outstanding data queries from data managers, project statistician and sponsors; completes and submits case report forms on as close to a Attends investigator meetings as required or as requested by the investigator and assists the investigator in communication of study requirements to all individuals involved in the study and provides appropriate training for study teams members; documents date of training and signatures of study personnel trained on study specific training log as appropriate; alerts the investigator when the research participant's safety is in jeopardy, there is a protocol deviation, or when the research participant request premature study termination.Randomizes research participants using an interactive voice response system or other system as applicable and maintains all test article records as required by regulatory agencies and sponsor's requirements; prepares emergency use or expanded access reports as applicable.Optimizes the safety of research participants by monitoring and reporting any non-serious or serious adverse events to the investigators and other members of the study team; presents investigator with relevant information for determination of seriousness, causality and intervention; assists investigator (as appropriate) in classifying adverse events (e.g., serious, moderate, unexpected); acts on investigator's recommendation for adverse event intervention (e.g., stop test article, call research participant, re-test, treat); maintains follow-up to determine resolution of adverse event.Collaborates with the investigator and administrative leadership to prepare a categorized budget and justification; confirms the accuracy and completeness of budgeted costs; reviews and develops familiarity with the executed contract to ensure that the study is in compliance with all terms and conditions, health and safety precautions for research participants and any financial terms and conditions.Understands and complies with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context; oversees and ensure registration of each research participant according to the billing matrix/billing plan and ensures billing of study procedures and/or visits to the appropriate funding source.Oversees the return or dispose of unused supplies per sponsor requirement; reconciles test article accountability; documents research participants who are lost to follow-up or who have dropped out (e.g., causes, contact efforts); assists in the preparation for a potential routine pre-market approval (PMA) FDA inspection as applicable.Supports an investigator-initiated IND or IDE study; prepares for internal or external audits and/or FDA inspections; assists and facilitates research and/or project team meetings; coordinates multi-center studies as applicable; acts as a liaison for research participants, investigators, sponsors and healthcare professionals and compose clear, precise and detailed correspondence; schedules and leads site qualification, study initiation, monitoring and close-out visits;Ensures that all key personnel engaged in the research project have met training requirements in accordance with Federal regulations, institution and sponsor policies and procedures; maintains effective and ongoing communication with sponsor, multidisciplinary, ancillary and inter-professional research teams; understands and contributes to scientific center goals and growth and maintains knowledge in the field through attending related project meetings, reading related literature and maintains professional associations as appropriate.Must comply with federal, state and sponsor policies; must comply with institutional policies, procedures and guidelines; must possess working knowledge of the ethical treatment of research participants, aspects of human protection and safety in the conduct of clinical research: 21 CFR 50 Protection of Human Subjects, 21 CFR 54 Financial Disclosure, 21 CFR 56 Institutional Review Boards, 21 CFR 312 Investigational New Drug Application (NDA), 21 CFR 812 Investigational Device Exemption (IDE), and 21 CFR 600 Biological Products; must possess working knowledge of Good Clinical Practices (GCP) provided by the International Conference on Harmonization (ICH); required MedStar Health Research Institute trainings including Collaborative Institutional Training Initiative (CITI); Conflict of Interest (COI), annual MedStar Health mandatories.Generates, designs and makes recommendations to improve research participant recruitment and retention programs to study leadership; communicates challenges with recruitment and retention to study leadership.Participates in multidisciplinary quality and service improvement teams as appropriate. Participates in meetings, serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate.