Clinical Trial Associate
Clinical Trial Associate
There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.
Your Impact at TESARO:
Provide clinical trial coordination support including clinical status tracking, in-house study management, document management and data review activities in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice.
- Support the Clinical Trial Manager in management of clinical trials, including site start-up activities. Complete study tracking and report on study status.
- Perform data entry into the Clinical Trial Management System (CTMS).
- Participate in vendor and study team meetings, including drafting of agendas, minutes and other meeting materials as needed.
- Manage trial-related documents in the Trial Master File (TMF); review documents for completeness, accuracy and compliance with protocol and applicable regulations and standard operating procedures.
- Perform quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant with use of required systems and documentation e.g. eTMF, CTMS, study team share points and others as required.
- Track delivery and receipt of required supplies and materials to study sites.
- Support investigator meeting preparation and collection/distribution of materials.
- May participate in the training of CRO teams, investigators and study team members.
- Bachelor’s degree in life sciences or equivalent training required
- At least 2 years of relevant work experience in clinical trial support, data coordination or a pharmaceutical or CRO environment
- Excellent verbal and written communication
- Working knowledge of ICH/GCP regulations and clinical protocols
- Demonstrated computer aptitude in MS Office Suite and other systems
- Ability to travel up to 10%
- Accommodates a flexible work schedule according to clinical trial(s) priorities
TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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