Sr. Clinical Research Associate

Delivering on the promise of medical innovation begins at Boston Scientific.

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Sr. Clinical Research Associate - Asthma Device

Job Description:
Position Summary:
Executes clinical trials to support business objectives by leading team(s) and managing deliverables across clinical functions and at participating clinical study sites.
Primary Duties and Responsibilities:

Initiates, monitors, and manages clinical trials.
Participates in clinical site recruitment.
Serves as a primary liaison between company and contract research organizations, field sites, investigators, study coordinators, physicians and staff members.
Participates in pre-study and site initiation planning.
Draft clinical protocols, case report forms, other data and tracking forms, informed consent documents, and operating procedures
Monitors clinical and/or laboratory data to ensure accuracy, thoroughness and regulatory compliance of clinical documentation. Ensures resolution of data queries.
Provides technical assistance and training to study sites regarding the conduct of clinical research and the use of study devices.
Tracks data forms, reports and documents necessary for completion of clinical study both in-house and from participating study sites, analyzes data reports and present regular project updates to management.
Performs clinical safety monitoring, site evaluation and closeouts.
Oversees delivery and shipment of products and equipment required to conduct clinical investigations.
Drafts annual and final clinical study reports and clinical sections of regulatory filings.

Job Experience:
Qualifications (Knowledge, Skills Abilities):
Minimum
• Bachelor's degree (B. A.) from four-year college or university and a minimum of 6 years industry experience (or equivalent), of which a minimum of 2 years in clinical project management.
• Three to five years related clinical research experience and/or training on complex multi-center clinical trials. Clinical experience in an early-stage medical device company is an advantage.
• Trained on ICH/GCP guidelines and familiar with clinical trial regulations.
• Excellent written and verbal communication skills
• Proficiency with Word processing, Spreadsheets, Internet software, E-mail, Database software
• Ability to negotiate contracts and budgets with contractors and/or clinical study sites.
• Ability to directly supervise1 to 2 subordinates.
• Ability to read, interpret and analyze general business periodicals, professional journals, technical procedures, and governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables simultaneously (multitasking).

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: None