Lead Coordinator, Research Study

Summary

• Position Summary
  • The Lead Coordinator, Research Study serves as the primary study coordinator and point person for the LCRP Clinical Research Program's Sub-Affiliate sites. In this role, the Lead Coordinator oversees the work and deliverables of the sub-affiliate program and is the contact person for coordinating auditing and monitoring activities at the assigned sites.  The Lead trains and oversees the duties of the Clinical Research Coordinator (CRC) and assists the CRCs with participant screening, enrollment, data collection, and data reporting.  The Lead will also review all serious adverse events experienced by clinical trial participants with the treating investigator. Additionally, the Lead performs all Research Coordinator duties within this multifaceted position in terms of enrollment of participants and coordination of clinical trials in accordance with SJ/C Policies and Procedures, Good Clinical Practice (GCP) as well as CTEP, Federal Food and Drug Administration (FDA) and local regulatory agency guidelines.  The Lead will work with site investigators & clinical staff to identify best practices for the sub-affiliate sites, as practices may differ in these smaller, community centers.  The Lead will work closely with the Clinical Manager of Research, CCDR and Trials and is the designee for assisting the Clinical Manager with research projects and tasks as appropriate.  The Lead will autonomously identify, troubleshoot and resolve site-specific issues while communicating with the Clinical Manager regarding research process improvements and workflow.  The Lead will also assist the pharmacists at the sub-affiliate sites with drug accountability while ensuring that investigational drug is handled in accordance with the stipulations specified by the sponsor.
• Education
  • Bachelors in Nursing - Required
• Experience
  • 2-3 Years Clinical Research - Required
• License & Certification
  • Professional License with State of Practice - Required
  • Professional Certification - Preferred
• Core Job Functions
  • Train Clinical Research Coordinators & investigators on new studies and/or systems in accordance with each clinical trial. Provide training and education to both research and ancillary clinical staff to ensure effective coordination of oncology clinic workflow and clinical trials processes.  Assist Clinical Research Coordinators with assigned tasks as necessary and provide oversight to ensure protocol compliance and quality data reporting.  Effectively problem-solves and works with team to improve processes for research participants at LCRP’s sub-affiliate sites. 
  • Completes assigned tasks timely and proficiently and in accordance with research specifications and guidelines. Maintains quality service and departmental standards by adhering to and ensuring that all staff involved in clinical trials adhere to SJ/C Policies & Procedures, GCP, and FDA & CTEP guidelines.  Communicates efficiently with research partners and study sponsors regarding all research activities at the assigned sub-affiliate sites, including the coordination of auditing and/or monitoring of the assigned sub-affiliate sites.
  • Assist with the identification of new research protocols, complete new study surveys/feasibility documents and track progress of potential new studies. Assist with training activities for medical and research staff.
  • Identify, screen and enroll patients to clinical trials per established goals. Ensure appropriate patient per inclusion/exclusion criteria. Schedule follow-up visits/clinical tests and discuss with applicable investigator(s). Coordinate patient's physical assessment by the PI and ensure modification of study treatment per protocol is overseen by the PI and/or CRC under supervision of the investigator. Monitor and facilitate patient compliance with medication, maintain pharmacy study drug binders and ensure drug accountability maintained for assigned protocols (zero drug discrepancies or documentation supporting otherwise). Monitor patients throughout trial for all untoward reactions and communicate to PI. Assist in completion of screening/subject enrollment tracking logs and resolution of queries. Order tests and submit data within required time frame.
  • Assist with the reporting of Serious Adverse Events, Progress Reports, revised Informed Consents, Amendments, Investigator Brochures, and Safety Reports to the IRB as needed. Maintain necessary supplies for study/infusion therapy, including medications and study/medical supplies. Audit Outcomes Acceptable/Acceptable with Follow Up.