Clinical Research Coordinator II

Implements and coordinates research and administrative procedures for the successful management of clinical trials. Performs diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. Enters study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.

What you will do

• Regulatory responsibilities include the oversight and/or responsibility for the Intuitional Review Board (IRB) submissions, and other related regulatory forms (e.g., scientific review), and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensureing the appropriate delegation of study related tasks (i.e., Delegation of Authority).
• Explains the informed consent process and the study to the research participant (e.g., purpose, duration, risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent.
• Develops an effective recruitment plan (e.g., central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study;
• Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries, clarifications and outstanding data queries and appropriately communicating with the sponsor and/or Contract Research Organization (CRO); completing and submitting case report forms on as close to a real time basis as possible.
• Ensures proper collection, processing and shipment of biospecimens and pharmacokinetics as applicable (e.g., centrifuge, freezing, refrigeration) and maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens;
• Assists with maintaining equipment (e.g., calibration, preventive maintenance); communicates with manager, investigator and sponsor regarding abnormal laboratory values; maintains Internal Air and Transportation Association (IATA) training for routine packaging, labeling and transporting of biological materials.
• Study conduct responsibilities include research participant interviews and assessments at study visits as required by protocol; assessing and ensuring research participant safety through study participation; maintaining close communication with investigator;
• Attending investigator meetings as appropriate and communicating relevant information to the research team; understanding and proficiently communicating all components of research documents, such as protocol, investigator brochure and research instructions.
• Receives and maintains test articles from sponsor and inventory test articles; works with research pharmacist as applicable; stores test article supplies according to Food and Drug Administration (FDA) regulations and sponsor requirements; administers test article as appropriate;
• Retrieves test articles and calculates research participant compliance; maintains randomization and emergency codes of test article; documents on accountability log and research participant record (e.g., test article received, used, disposed).
• Ensures that non-serious and serious adverse events are properly identified, documented and reported according to all applicable requirements; presents investigator with relevant information for determination of seriousness, causality and intervention; 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.
• 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;
• Responsible for reviewing, understanding and accepting the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipends have been routed in a timely manner as applicable.
• Study close-out responsibilities include return or disposition of unused supplies per sponsors requirement; reconciling test article accountability; document research participants who are lost to follow-up or who have dropped out (e.g., causes, contact efforts); ensuring long term storage of documents; submitting IRB closing report (i.e., termination) after sponsor has closed study site.
• Acts as a liaison with research participants, investigators, sponsors and healthcare professionals; prepares for site qualification, study initiation, monitoring and close-out visits;
• Ensures all research participant encounters are updated as appropriate and within one business day in clinical trial management system (CTMS); works effectively with multidisciplinary, ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers.

Qualifications

• Bachelor's degree or an allied health or related professional degree required ,or equivalent work experience
• 2 years of relevant clinical research experience required
• Experience in a healthcare setting preferred
• Undergraduate and/or work experiences that demonstrates aptitude for research facilitation preferred
• Verbal and written communication skills.
• Basic computer skills preferred.