• Associate II , Clinical Research Job Jobs in United States Of America - 23847969

  • United States Of America, Usa
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level With determination, imagination and a deep caring for human life, were solving some of the most important healthcare industry challenges Together, were one global team committed to making a difference in peoples lives around the world This is a place where you can find a career with meaningful purposeimproving lives through your lifes work

About this role

Acts as an in-house Research Associate, provides support to clinical functions and site customers through site start up, enrollment, follow up and closure phases of clinical trial activities

Your responsibilities will include

Site Start-Up works across several studies to ensure all required documentation is in place to authorize sites for study enrollment Partner with other team members to support patient enrollment
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 analyzing study documents and metrics and general study data overview Support regulatory inspection activities as required Interact with internal legal team
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 (ie Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database Performs budget negotiations
Has a very good understanding and working knowledge of Clinical Study Regulatory requirements

What were looking for in you

Minimum Qualifications

Bachelors degree and 5 years of related experience or an equivalent combination of education and experience
Background in human clinical study experience required
Experience following SOP and WIs in a quality environment
Experience working with CTMS and CDC systems
ICF (Informed Consent Review) experience, IRB experience
Contract and Budget negotiation experience

Preferred Qualifications

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 18th Apr 2020

Key Skills:

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