Clinical Research Regulatory Spec I
Baystate Health, Inc.
Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT
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Req#: R8459 Category(s): Research, Research Support Full Time / Part Time: Full-Time Shift: FirstSummary: Job Responsibilities: 1) Works under limited supervision. Supervisor available to handle most unusual situations and review progress of work. 2) Analyzes complex scientific protocols and creates clear, concise, and accurate clinical research applications, consent forms, and correspondence. Creates and maintains databases to track study documentation, regulatory documents, and IRB submissions. 3) Reviews and contributes to policies and procedures to ensure regulatory compliance. May assist with limited clinical tasks/procedures as appropriate to training, supervision, and clinical area. Largely responsible for sponsor monitoring and close-out visits. 4) Responsible for well organized, professional, and complete study and regulatory files. 5) May perform actual study tasks/procedures as appropriate to knowledge, skill, and training. Manages many detailed projects simultaneously, completes projects in a timely and highly accurate manner. Serves as expert resource to Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities. 6) May assist with training and education of other study personnel. May have supervisory & budgetary responsibilities as appropriate. Required Work Experience: 1) Knowledge and skills necessary for this level are typically attained through 4-6 years of clinical research experience Preferred Work Experience: 1) None Listed Skills and Competencies: 1) Solid knowledge of medical terminology 2) Expert knowledge of Federal & State Regulations as they relate to research 3) Holds specialty certification in clinical research through an approved accrediting organization or college/graduate program You Belong At Baystate At Baystate Health we know that treating one another with dignity and equity is what elevates respect for our patients and staff. It makes us not just an organization, but also a community where you belong. It is how we advance the care and enhance the lives of all people. DIVERSE TEAMS. DIVERSE PATIENTS. DIVERSE LOCATIONS. Education: Non-Graduate (Required) Certifications: Equal Employment Opportunity Employer Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.