Senior Clinical Research Associate

Biotechnology and Pharmaceutical Senior Clinical Research Associate Job Description:Handles critical job competencies and takes on projects of a more complex nature. A well-rounded operational/functional/scientific skill set has been fully mastered and may have experience in some therapeutic areas. Lead and mentor junior level contributors in all aspects of the role.Key Responsibilities ? Track Screening & Enrollment and identify issues & address globally? Independently confirm that site regulatory documents match TMF act as a subject matter expert for Junior staff.? Contact sites on a consistent basis to assess study compliance.? Address non compliance issues at investigative site and develop CAPA if necessary.? Notes global trends as a functional lead and reports to project management.? Develops Project plan on Long Term Follow-up (LTF) Project.? Manages deliverables, disseminates project information, tracks metrics data and budget management.? Leads clinical team meetings on LTF studies under Sr. Project Management guidance.? Monitor Case Report forms against medical records on complex trials.? Write confirmation letter, site visit report and follow up letter. Assist CRA 1 in these tasks? Conducts site qualifications visits.? Conducts site initiation visits.? Present at study-specific teleconferences and investigator meetings.? Reviews summaries of medical publications and past study summaries.? Write portions of protocol under guidance of Project Manager.? Utilize clinical knowledge to improve clinical compliance across department and at external sites with compliance issues.? Train on protocol and assist with protocol interpretation? Site CAPA process and re-training.? Lead more complex studiesFully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).Bachelors Degree in Science or Healthcare Related Field, Masters preferred.3-8 years experience in clinical/scientific research, medical experience.Job Experience:Bachelors Degree in Science or Healthcare Related Field, Masters preferred.3-8 years experience in clinical/scientific research, medical experience.Minimum Education Required: BachelorYears of Experience Required: At Least 3 YearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.