Senior Clinical Research Associate

Job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. Job Summary The 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. Job Details/Responsibilities 1. Support the investigator evaluation and recruitment process: o Create phone scripts, questionnaires, and other assessment tools for use in the selection of sites; o Assist team in the development of site recruitment and retention strategy; o Initiate contact with PIs, conduct pre-visits, assess potential investigators and recommend suitability of the site; 2. Assist clinical team with study start-up activities: o 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; o Requests and collects initial regulatory documentation; o Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval; o Performs study tracking and advises PM when an investigational site is approved and ready to receive investigational device supplies; 3. Site Management and study execution activities: o Plan and conduct training / site initiation, interim and close-out visits. Complete timely and accurate trip reports; o Assess and monitor that investigational devices are available, appropriately used, handled correctly, stored, and accurately inventoried and documented. o Follow up with the site regarding timely completion and retrieval of CRFs and data correction forms; o Assist sites to resolve regulatory document issues. Ensure adequate study and regulatory documentation is maintained at the both the investigator site and The company; o Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment; o 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; o 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. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range: $92,320 - $126,940