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 Lead Clinical Research Associate to work with our innovative Clinical Research team in Burlington, MA.
The Lead Clinical Research will be r esponsible for managing clinical monitoring activities for one or more clinical studies. Responsible for the development and oversight of project specific training of CRAs, vendors, and 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. Participates in the development of formal clinical summaries and reports for regulatory submissions. Writes clinical procedures and develops study specific tools and templates. Leads the activities of others and may have supervisory responsibilities. Leads study training and the development/planning activities, specifically related to project tools and templates. Participates in the development of clinical protocols and case report forms. This position reports to 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.
- 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.
- 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.
- May have supervisory responsibilities.
- Oversees all monitoring activities on a project level. Ensures monitoring activities are performed in accordance with ICH-GCP, applicable regulations, and the study specific Monitoring Plan.
- Promotes operational efficiency, teamwork and high morale. Proactively prevents and identifies issues related to the clinical portion of the study, including study processes, monitoring or site issues.
- Develops the study specific Monitoring Plan and ensures compliance with all monitoring related tasks throughout the study.
- Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization.
- Oversees site start-up activities, including site selection and regulatory document collection, review, approval and tracking.
- Sets up and maintains Clinical Monitoring tracking tools.
- Develops study tools and templates for monitors and site personnel. Provides guidance and instructions as needed.
- Develops and oversees study specific training materials for internal study team and vendors. Maintains documentation of training throughout the life of the project.
- Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.i, Missing CRF pages, Outstanding Monitoring Reports, etc.)
- Reviews patient data/summaries from study sites to monitor for trends that require proactive site management.
- Serves as primary Sponsor contact to sites on study related questions.
- Travels to clinical sites as needed to provide senior level study support to sites and CRAs.
- Participates in the development of formal clinical summaries and reports for the writing of regulatory submission documents.
- Oversee the clinical monitoring budget and site payments.
- Plans, writes and maintains clinical procedures.
- Able to work with minimal supervision.
- Frequent travel is required (up to 30% travel).
- Bachelor's degree or R.N.; plus 4-5 years related experience and/or training, including at least 3 years as a CRA; 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. Must possess computer literacy and proficiency in MS Office.
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 (Thoratec) is a manufacturer of mechanical circulatory support products for use by patients with heart failure (HF)....