Additional Locations: US-MA-Marlborough; US-MN-Minnetonka
Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About this role:
Manages progress of clinical studies at the study and site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start-up, enrollment, follow up and closure of clinical trial.
**Open to location of Massachusetts or Minnesota depending on education and experience.
Your responsibilities will include:
- Site Start-Up: works across several studies to ensure all required documentation is in place to authorize sites for study enrollment. Partner with other team members to support patient enrollment.
- Communications: 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. Interact with internal legal team.
- Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
- Collaboration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.
- Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.
- Has a very good understanding and working knowledge of Clinical Study Regulatory requirements.
What we’re looking for in you:
- Bachelor’s Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
- 7+ years experience in clinical/scientific research and medical device experience
- Experience following SOP and WIs in a quality environment
- Experience working with CTMS and CDC systems
- ICF (Informed Consent Review) experience, IRB/EC experience
- Study budget review (monthly) and reporting variances with rationale
- Must be able to travel approximately 25-35%
- 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 skills – written and verbal
- Must be comfortable interacting with site personnel via phone, email, and in person
- Very high focus on Customer Service
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer - Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 452757