Sr. Clinical Research Associate

Additional Location(s): 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:
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.


Relocation:
Relocation assistance is not available for this position at this time.

VISA:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• 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.

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

Requisition ID: 632544

Minimum Salary: $ 85000

Maximum Salary: $ 161500


The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.