Senior Clinical Field Monitor - Colorado

Job Description: Are you an innovator looking for the next step in your career? Join Boston Scientific! We are currently experiencing tremendous growth and are looking for seasoned Clinical Field Monitors in our Colorado / West region. This is a home based regional role. Typical travel is 10 days of site visits per month.

General Summary:
A senior-level position in Clinical Research, under some supervision of Project/Program Managers this position participates in the planning, designing, and executing of high quality clinical studies to ensure safety and effectiveness of BSC products. Candidate works with confidential patient and company data, and interfaces with a variety of internal and external stakeholders. Depending upon Clinical requirements may be directly involved in the monitoring of trials. The person in this role may be asked to represent Clinical function on PDP teams.

Duties and Responsibilities:

May participate on PDP project teams though participation in phase reviews and documentation creation and/or revision.

Participates in the site qualification and initiation process, including scheduling monitoring activities with site personnel.

Assists Clinical management with the development, negotiation, and execution of the site contract, budget and payment plan, with final approval from Clinical management.

Assists Clinical management with development, approval, and distribution of study-related documents including Case Report Forms (CRF's), study protocols, study manuals, and other study tools to investigational sites and review committees.

Drafts informed consents under direct supervision.

Gathers documents and information for clinical investigator and laboratory selection.

Manages device accountability, inventory, and distribution. Manages the oversight of device complaint/malfunction process and tracking.

Based upon Clinical requirements, may monitor on-going compliance to study protocols and site adherence to global regulatory guidelines.

Prepares and participates in presentation of protocols and other study conduct requirements at study initiations at investigational sites when needed.

Oversees subject screening and enrollment at assigned clinical sites.

Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.

Assists in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training.

Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ's. Assists in query writing and resolution process, as required. Identifies and gathers missing or incomplete data from the investigational sites.

Provides mentoring to junior staff regarding protocols, site management, etc.

Reviews Case Report Forms for clinical content.

Prepares Clinical Risk/Benefit Analysis (CRBA) under the direction of clinical management.

Assists clinical project manager with developing/maintaining project timeline, managing study budget, and preparing routine operations reports.

Assists clinical project manager with core lab activities and data monitoring committee responsibilities

Conducts site visits, as necessary. Acting as a company liaison, work with clinical sites to resolve any site related issues quickly and effectively.

Provides on-call help for sites, as well as on-going site training

Coordinates Clinical staff in the oversight of site compliance including the development and implementation of corrective actions for addressing noncompliance issues.

Assists Clinical staff in identifying sites to be audited by either Corporate Compliance or Clinical staff. Assists with study site audits.

Tracks regulatory agency audits of investigational sites and analyzes outcomes.

Assists Clinical management with regulatory submissions, and other reports as required.

Oversees on-going literature searches; performs therapeutic area/product specific reviews.

Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP's and Work Instructions.

Minimum Education & Experience:
Bachelor's-level degree required. Degree in science/health related field (e.g., Biology, Nursing,
Biomedical or Veterinary Science

Searchable Keywords: Senior Clinical Field Monitor - Colorado home based / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: At Least 3 Years

Expected Travel Time: About 50%


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.