Remote BasedThe Sr. CRA supports the day to day operations associated with the execution of clinical trials. He / she will monitor multiple clinical trial sites and studies. The primary objective and purpose of this position is to ensure the overall quality of clinical trials by monitoring study data and managing site adherence to the protocol, GCP, all applicable regulations and related study documents. The Sr. CRA is the primary contact with the study site and serves as the liaison between clinical investigators and Terumo. Will be responsible for site training, regulatory document collection, tracking enrollment, and ensuring case report forms are accurate, complete and verifiable against source documents. The Sr. CRA is expected to contribute to the development and improvement of company procedures, processes, and templates in support of Terumos efforts towards continuous quality improvement. Support the investigator evaluation and recruitment process: Create phone scripts, questionnaires, and other assessment tools for use in the selection of sites; Assist team in the development of site recruitment and retention strategy; Initiate contact with PIs, conduct pre-visits, assess potential investigators and recommend suitability of the site; Assist clinical team with study start-up activities: Assist in development of protocol / ICF / CRF / CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools; Requests and collects initial regulatory documentation; Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval; Performs study tracking and advises PM when an investigational site is approved and ready to receive investigational device supplies; Site Management and study execution activities: Plan and conduct training / site initiation, interim and close-out visits. Complete timely and accurate trip reports; Assess and monitor that investigational devices are available, appropriately used, handled correctly, stored, and accurately inventoried and documented. Follow up with the site regarding timely completion and retrieval of CRFs and data correction forms; Assist sites to resolve regulatory document issues. Ensure adequate study and regulatory documentation is maintained at the both the investigator site and The company; Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment; Document and report non-compliance in a timely manner. Identify areas requiring follow-up and improvement at each clinical site, recommend corrective action and or conduct site re-training as needed; Communicate findings from contact reports and monitoring visits to CRA Mgr and PM in a timely manner.
Knowledge, Skills and Abilities:
(KSA) Thorough understanding of operational aspects of clinical research and regulatory regulations; Good interpersonal, problem solving and communication skills; Excellent follow-through capability; Self-motivated, attention to detail and organizational skill; Experience with various computer systems / applications and clinical trial management systems; willingness to learn new systems / databases as needed. Qualifications/Background Experiences: BS / BA or higher in a clinical or scientific area required; RN is preferred; Minimum of 5 years experience independently monitoring clinical trials; medical device preferred; or equivalent education and work experience.
