Additional Locations: (n/a)

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – 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 the Role:

Acts as a Clinical Research Associate I works with clinical project teams and Clinical Research Associates to support the completion of clinical trial documentation processes, budgets, contracts and device management. Provides support to clinical functions and site customers through study and site start up, enrollment, follow up and closure phases of clinical trial activities.

Your Responsibilities Include:

• Manage Study Master File(s).
• Documentation:
  • Collect study contracts, request / collection of relevant investigator / site documentation (i.e. Regulatory Docs, FDF, CV/ML), review and approval of subset of documents in applicable database.
  • Process core study documents (upload, assigning of attributes, filing, review and approval of subset of documents in eTMF).
  • Ensure successful study start-up (e.g. site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study
  • Follow BSC SOP/WI and GCP.
• Manage study and site document archives (paper and/or electronic) as required.
• Direct communication with site personnel to collect core trial documents, including training documents, and file in accordance to the Study Master File.
• Assembly & distribution of study documents & mass communications (e.g. Manual of Operations, Study Tools, Newsletters, Annual Reports).
• Monitor and report project-specific training compliance, for site and internal team.
• Manage site/contact/study information using appropriate tool(s).
• Review Informed Consent Form and assist with IRB submission(s) and review of IRB documentation
• Site Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment. Partner with other team members to support patient enrollment.
• Collaboration: participate in study-specific meetings, teleconferences and trainings. Collaborate with cross-functional team members and study sites throughout all study phases.
• Solid understanding and working knowledge of Clinical Study Regulatory requirements.
• • Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.
  • Communication: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
  • Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
  • Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through analyzing study documents and metrics, and general study data overview. Support regulatory inspection activities as required.
  • Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
  • Perform budget negotiations and/or interact with internal legal team, as needed.
  • Coordinate all translations, as applicable.May need to conduct:

What We’re Looking For:

Minimum Qualifications:

• Bachelor Degree in science/health related field (e.g., Biology, Nursing, Biomedical) or an equivalent combination of education/work experience
• Background in human clinical study experience
• Experience following SOP and WIs in a quality environment
• Experience working with CTMS and eTMF systems
• Experience with ICF (Informed Consent Form) review
• Experience working with Institutional Review Board(s)
• Proficient with MS Office
• 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 skills – written and verbal
• Must be comfortable interacting with site personnel via phone, email, possibly in person

Preferred Qualifications:

• Research Coordinator and/or Clinical Research Associate experience preferred
• Contract and Budget negotiation experience
• Very high focus on Customer Service
• Ability to travel as needed

Requisition ID: 503759

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.

Nearest Major Market: Los Angeles
Job Segment: Research Associate, Clinic, Medical, Clinical Research, Research, Healthcare