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Senior Clinical Research Associate

JOB SUMMARY:      The Sr. CRA is accountable for the day-to-day operations of assigned gene and cell therapy clinical trials, including trial start-up, conduct and close-out activities. This position will perform required job duties with minimal guidance and ensure trial timelines, costs and quality metrics are met while the conduct of clinical trials is in compliance with the study protocols, SOPs, and applicable regulatory requirements. We will consider a CRA level candidate who demonstrates high potential for this role.  Title and compensation will be matched to experience.   ESSENTIAL FUNCTIONS (include but are not limited to):  Assist in the design, planning and implementation of clinical research projects, including drafting project plans and timelines as needed Manage the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study budgets Negotiate and finalize site contracts and budgets, manage and calculate site payments Perform site visits including site qualification, initiation, monitoring and close-out visits Hire, train and supervise regional monitors and review monitoring reports Ensure sites comply with study protocol (to ensure accurate and complete data collection) and federal regulations Represent Sangamo Therapeutics in a professional manner; establish and maintain good relationships with investigators, study site personnel, and collaborators Maintain frequent site contact; and prepare, track, and manage required study documentation and supplies Oversee and track project progress at assigned sites (subject status, safety/adverse events, CRF completion, payments, clinical sample management, regulatory documents) Review data listings on an ongoing basis Determine and oversee site investigational product requirements and accountability and other supply requirements Plan and coordinate Investigator Meetings Assist in preparing interim study analyses, annual reports, and clinical study reports Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS) Reviews draft statistical reports for accuracy and consistency Participate in internal and external audits Mentor and train junior Clinical Research Associates   EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: BA/BS degree in a nursing, pharmacy, life sciences or health-related discipline Minimum 5 to 7 years of industry experience in planning and managing clinical trials for biotechnology or pharmaceutical companies Demonstrated ability to supervise a clinical trial from initiation to close in accordance with regulations and with company policies and procedures Thorough knowledge of GCP, ICH and FDA regulations Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment Self-motivated, assertive and able to function independently and as part of a team Strong written and verbal communication; strong interpersonal skills   OTHER REQUIREMENTS: Gene and cell therapy and rare disease clinical trialexperience desirable Ability to travel up to 30%
Salary Range: NA
Minimum Qualification
5 - 7 years

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