Pioneering Therapies, Transforming Lives . What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Clinical Research Associate II to work with our innovative Clinical team in Burlington, MA.
The Clinical Research Assocate II will be r esponsible for performing clinical monitoring visits including site qualification, site initiation, interim monitoring visits and study close-out visits. Responsible for the oversight and training of study site personnel to ensure adherence to the protocol and investigational plan, data integrity, accurate source documentation, compliance and adherence to local, FDA GCP/ICH requirements and where applicable, international regulatory requirements, and accurate storage and disposition of investigation product and study supplies. Assists with formal clinical summaries and reports for regulatory submission documents. Writes clinical procedures. Participates in and/or leads study development, clinical training initiatives and projects/study team activities. This position reports into Clinical Affairs Management.
This position is responsible for, but not limited to, the following:
Represents the company to clinicians for issues associated with Clinical Affairs activities.
Works with a multi-disciplinary team to identify key clinical centers and affiliated collaborators for implementation of formal clinical studies of new products and/or new product indications.
Organizes, monitors, implements and reports clinical study progress to the clinical management team as required.
Collects, reviews, verifies and summarizes patient data from study sites. Serves as primary contact to sites on study related questions. Troubleshoots complex study and data related issues.
Independently oversees Contract/Regional Clinical Monitors and reports progress and/or risk to Clinical Management/Program Manager.
Responds to internal and external customers and clinicians involved with product-related complaints or concerns, specific to issues involving potential or real patient safety or device efficiency.
Enforces compliance of Thoratec Clinical Procedures and SOPs.
Enforces compliance with and Good Clinical Practice (GCP), local, Federal and International Regulatory requirements as applicable and required.
Coordinates data related activities with data management team including data review, verification, clarification and transmission.
Assists in the administration and control identification of shipment, use and return of non-sterile and sterile investigative products to key domestic and international investigational centers.
Creates and maintains patient, study and regulatory files and status reports.
Travels to clinical sites to initiate, monitor compliance and perform closeout visits for clinical studies.
Periodic monitoring of protocol pager for urgent site/subject related issues.
Identifies complex issues/barriers to the successful conduct of a clinical study and proposes improvements to this end.
Participates in and/or leads study development and start-up process including development and review of study related tools.
Assists the Clinical Manager/Clinical Program Manager with the development of formal clinical summaries and reports for the writing of regulatory submission documents.
Participates in clinical study budget management and site payments.
Works with the Clinical Management Team to create training for Clinical Affairs personnel.
Leads clinical training initiatives for internal team as well as study specific training for vendors providing clinical study support.
Plans, writes and maintains clinical procedures.
May supervise the activities of study team (Clinical Research Assistants, Clinical Data Management staff and/or Clinical Research Associates).
May lead projects.
Able to work with minimal supervision.
Frequent travel, including occasional international travel, is required (up to 30%).
Bachelor's degree or R.N.; plus 2-5 years related experience and/or training; or equivalent combination of education and experience.
Sound knowledge of medical terminology, FDA Regulatory Requirements, Good Clinical Practices (GCP's) and clinical monitoring processes.
Ability to organize, multi-task and manage multiple study sites with a strong attention to detail.
Computer literacy and proficiency in MS Office.
Ability to work well in an environment that is team-oriented and collaborative.
Why work for us?
For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. We value people who are passionate about collaboration, creativity, and quality. We give back to our community and help people live healthy lifestyles through support, education, involvement, and participation.
Thoratec employs more than 700 people worldwide. We are based in Pleasanton, California, with facilities in Burlington and Waltham, Massachusetts; Sunnyvale and Rancho Cordova, California; Cambridgeshire, UK; and Zurich, Switzerland.
Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer.
Thoratec Corporation - 2 years ago
Thoratec Corporation (Thoratec) is a manufacturer of mechanical circulatory support products for use by patients with heart failure (HF)....