Senior Clinical Research Associate

Hiring Manager: Sheliza N Jiwani
Recruiter: Lapanika Sharma

About the role:

The Senior Clinical Research Associate 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. This role also provides support in startup, enrollment, follow up and closure of clinical trial activities.
 
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:

• Bachelor’s degree and/or equivalent combination of education and experience
• Minimum of 5 years of clinical research experience and monitoring experience

 
Preferred qualifications:

• Experience monitoring device studies
• Preferably medical device experience, knowledge of applicable clinical research regulations (FDA, GCP, ISO) 
• Strong communication and organizational skills required
• Travel flexible up to 50 percent
   

Requisition ID: 576887

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

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 prohibited substance 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