Clinical Research Associate II - Upper Mid Atlantic Region Job
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POST DATE 9/12/2016
END DATE 10/9/2016
Boston Scientific Corporation
JOB DESCRIPTIONAPPLY PRIMARY LOCATION: US-PA-Philadelphia
ADDITIONAL LOCATIONS: (n/a)
REQUISITION ID: 269085
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Cardiac Rhythm Management (CRM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. We've been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies.
* Field based role covering sites in the Upper Mid Atlantic Region
Specialist responsible for clinical research field monitoring and project team clinical research support throughout the full lifecycle of a clinical project. Support of projects of a more complex nature and mentoring and training of junior level staff.
Role: Site Manager
- Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.
- Manages assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs.
- Participates in site start up activities as assigned.
- Supervises screening & enrollment at assigned clinical sites.
- Routinely reviews site compliance data and works to identify compliance risks and issues.
- Partners with field staff to develop a CAP to address non-compliance issues as appropriate.
- Manages the completion of assigned project specific deliverables.
- Participate in site close-out activities for assigned clinical sites.
- Partners with colleagues to ensure assigned sites are audit ready at all times.
- Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.
- Addresses non-compliance issues and trends at investigative site; develops, documents and implements a CAP as necessary.
- Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
- Participates as an extended team member of the clinical study team including: participating in study-specific meetings, teleconferences and investigator meetings.
- Conducts device accountability at clinical sites.
- Conducts study specific training for new study coordinators.
- Ensures that all adverse events are identified and clearly documented during visits.
- Serves as a mentor and trainer of junior Field CRA staff.
Role: Quality and Process Improvement Champion
- Identifies and Reports complaints.
- Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute corrective action plans.
- Ensures training is completed per the required timelines and project needs.
- Identifies process improvement opportunities. Independently proposes solutions/plans.
- Tracks internal process metrics data to measure performance.
- Bachelor's Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
- 3+ years experience in clinical/scientific research, medical device experience
- CRM Electrophysiology device study experience preferred
- Candidate needs to reside in location within reasonable travel distance to the Upper Mid Atlantic sites
- Must be able to travel 50-75%
QUALITY SYSTEM REQUIREMENTS:
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
BOSTON SCIENTIFIC (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 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. For more information, visit us at www.bostonscientific.com.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-PA-Philadelphia||(n/a)||Clinical||(n/a)
Nearest Major Market: Philadelphia
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