Clinical Research Coordinator III - Cardiology

General Summary of Position
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.

Primary Duties and Responsibilities

• 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).
• 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 real time basis as possible.
• Works with study team as needed to define biospecimen collection processing and storage procedures; trains others as needed to collect and label samples as instructed and delivers or processes samples in accordance with protocol; communicates with manager investigator and sponsor regarding laboratory findings and recognizes common laboratory values and alerts; maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens and International Air Transportation Association (IATA) training for routine packing labeling and transporting of biological materials.
• 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.
• 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.

Minimal Qualifications
Education

• Bachelor's degree required, or an allied health orrelated professional degree andequivalent 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 Abilities

• Excellent verbal and written communication skills.
• Strong communication and organizational skills.
• Proficient computer skills.