Clinical Research Coordinator (Experienced)

Responsible for the daily operations and overall management of assigned clinical trials including administrative duties and regulatory functions. Responsible for clear and direct communication with study sponsor, study monitor, CRO, PI and site management. Adherence to Tekton SOPs is required. The CRC II works collaboratively with the CRC I to train and guide them on Tekton SOPs, protocol, and regulatory compliance. It is the responsibility of the CRC II to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner. Job Description Enrollment of clinical trials according to protocols, identifying ways to exceed enrollment goals. Confer with the recruitment department and site management to determine the best recruitment practices for assigned studies. Inform patients or caregivers about studies and associated procedures. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Know the contents of and maintain assigned study e-regulatory binders, self-check all binders for compliance and forward any missing documentation to binders regularly. Follow all Tekton work instructions, guidelines, policies, and controlled documents, assist CRC-Is as needed by providing guidance on following and applying these documents. Scheduling of study visits and monitoring schedules according to protocol and study plan. Have all source documentation completed while the patient visit is occurring and while the patient is on site for optimal accuracy and completeness of data collection. Apply relevant good documentation practices. Data collection: all source documentation completed and entered into EDC within one business day of patient visit. Ensure data queries are resolved in the EDC within 48 hours of query being issued. Inventory lab and study supplies. For assigned studies maintain an acceptable threshold of supplies required to complete study visits and meet site enrollment goals. Attend investigator meetings with principle investigator: asks questions and collect pertinent study information while at any investigator meeting. Attend site initiation visits from various drug sponsors and conduct site initiation tours. Maintenance of required records of study activity including case report forms, drug dispensation records. Perform specific protocol procedures and interpret complex medical data (ie: interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens) as required. Communicate with laboratories or investigators regarding laboratory findings. Record adverse event data and confer with investigators regarding the reporting of events. Manage study data entry, ensuring timelines are met for entry of all source data into study systems/EDC. Direct the requisition, collection, labeling, storage, or shipment of specimens. Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as required. Identify, report, and problem solve protocol deviations or unanticipated events. Drug Accountability. Logging investigational product shipments and reporting received as required. Thorough documentation if lost or damaged. Logging dispensed medication to subjects in appropriate medication log as required per study protocol. Initiate and maintain accurate master logs for each study. (ie: ICF, patient ID, and enrollment logs). Participate in quality assurance audits as required. Ensure IP management for assigned trials: Space for investigational products is labelled and organized and required. All IP is stored with restricted access immediately once the IP arrives at the site and checked in by delegated staff. Maintain assigned study training logs/Delegation logs as required. Maintain all safety reports for all studies. Confirm PI is aware of safety reports to be reviewed and that reports are signed as required by investigators. Maintain confidentiality of patient protected health information and sponsor confidential information. Other duties as assigned. Required Skills/Abilities Experience leading multiple clinical trials as lead CRC preferred. Ability to work independently and as a member of a team. Ability to train and guide staff effectively and knowledgeably. Effective verbal and written communication skills. Ability to read, write, and speak English language. Knowledge of high-level medical terminology. Potential for travel to assist & train at Tekton Research sites. Education and Experience GED or HS Diploma required (Some College preferred). 2 - 5 years clinical research experience required. Phlebotomy if required by state law. #J-18808-Ljbffr