Additional Locations: Remote
Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About this role:
Supports the Global Clinical Trial Operations Center of Excellence, conducting activities consistent with the mission of Global Clinical Operations to inform, connect and advance the company’s Global Clinical Organization. Through collaboration with divisional and regional clinical teams, the Clinical Research Associate II conducts clinical trial site start-up activities for applicable clinical trials, ensuring they are carried out consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.
Your responsibilities will include:
- Work independently and proactively to coordinate all necessary activities required for setting up a clinical study and maintaining study documentation.
- Proactively manage and problem solve study start up challenges.
- Perform & manage site budget, contract and informed consent reviews & negotiations.
- Develop, prepare, complete and track required legal documentation.
- Document clinical site and investigator readiness for participation in clinical research studies
- Prepare and follow-up of internal quality audits, as well as, regulatory audit inspections.
- Update and maintain study-specific startup trackers.
- Attend project meetings and provide updates on study-specific site activation status.
- Effective communication skills when interacting with key opinion leaders, investigators, study staff, and project teams.
- Perform ongoing reviews of the Trial Master File and Investigator Site Files (ISF) to assure quality & inspection readiness of the files, ensuring compliance with SOPs, ICH/GCP Guidelines, and applicable local regulatory requirements.
- Ensure compliance with appropriate regulatory (ICH/GCPs, FDA, IRB, etc.) and internal SOPs/WI, policies & procedures
- Communications: ensures clear written communication to clinical sites and project team members through follow-up letters, study memos, and general correspondence.
- Site Compliance: during the start-up phase, ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required.
- Collaboration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout the startup phase.
- Documentation: Manages & tracks study start up contracts and budgets
What we’re looking for in you:
- Bachelor’s Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
- 2+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US
- Experience following SOP and WIs in a quality environment
- Experience working with CTMS and CDC systems
- Contract and Budget negotiation experience
- Research Coordinator or Clinical Research Associate experience
- Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment
- Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal
- Must be comfortable interacting with site personnel via phone, email, and in person
- Clinical study site start-up experience outside of the US desired, but not required
- Very high focus on Customer Service
Requisition ID: 480652
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.