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Principal Clinical Research Associate Job

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Date: Jun 8, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove; 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:

This Principal Clinical Research Associate 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 Principal Clinical Researcher conducts clinical trial site start-up and monitoring 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.  Monitors progress of clinical studies at the site level to verify that the rights and wellbeing 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 startup, enrollment, follow up and closure of clinical trial activities.

 

Your responsibilities will include:

  • Work independently and proactively to coordinate all necessary activities required for setting up a clinical study and maintaining study documentation
  • Problem-solve specific clinical trial issues
  • Participate in the design and preparation of clinical trial documents such as protocols, case report forms, source documents, informed consents and IRB submissions
  • IRB/EC management including site application assistance and approval tracking
  • Prepare and follow-up of in-house and on-site sponsored quality audits, as well as, regulatory audit inspections
  • Update and maintain study-specific study startup and monitoring trackers
  • Coordinate and attend project meetings
  • Effective communication skills when interacting with key opinion leaders, investigators, and study staff
  • Perform ongoing reviews of the CTMF and Investigator Site Files (ISF) to assure quality of the documentation files and compliance with SOPs, ICH/GCP Guidelines, and any other regulatory requirements
  • Initiation of selected clinical sites by providing training related to the protocol and management of the study
  • Ensure compliance with appropriate regulatory (ICH/GCPs, FDA, IRB, etc.) and internal guidelines
  • 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.
  • 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 monitoring visits, analyzing study 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.
  • 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 documentation that may include 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. May perform budget negotiations.

 
What we’re looking for in you:
Minimum Qualifications

  • Bachelor’s Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
  • 10+ 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 experience
  • Contract and Budget negotiation experience
  • Must be able to travel 

Preferred Qualifications

  • 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

 

About us

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: 447409

 


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