Sr. Clinical Research Associate

Boston Scientific • Arden Hills, MN

2d • $85,000 - $161,500

About The Position

Monitors progress of clinical studies at the 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 activities.

Requirements

• University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines
• 3-5 years relevant experience required

Nice To Haves

• advanced/graduate degree preferred for some disciplines

Responsibilities

• 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 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.

Benefits

• Relocation assistance is not available for this position at this time.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.
• core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree