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Low Travel, Regional CRA opportunities with Alzheimer's experience NATIONWIDE ! (Science & Biotech)
ANYWHERE USA , NJ 07726
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Nov 15, 2020
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Job Description

Our client, a mid-sized growing team specializing in Phase I and II clinical research trials, is currently growing their team!
Home-based, full time regional CRA opportunities now available across the USA! Alzheimer's experience is necessary. 40% travel for this role.

The Clinical Research Associate (CRA) monitors activities at clinical trials sites to assure adherence to Good Clinical Practices (GCP), standard operating procedures, and study protocols. The CRA reviews regulatory documents as necessary, and prepares site visit reports. The person in this position is involved in the selection of potential clinical investigators and determines if facilities are adequate based on protocol requirements.

REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
• The position requires a Bachelor’s degree in life sciences, nursing degree, or equivalent, plus a minimum of one year experience as a clinical monitor.
• Demonstrated knowledge and a clear understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, drug safety and regulatory issues, and report generation.
• Must have proficiency with ICH/GCP guidelines.
• Excellent verbal and written communication skills, organizational skills, time-management, customer service, and interpersonal skills are required.
• Must be able to work independently.
• Certified Clinical Research Associate (CCRA) desired, but not required.

RESPONSIBILITIES
• Review of study protocol and familiarity with all study procedures
• Conduct pre-study visits to determine site and investigator qualifications; preparation of reports based on pre-study visits
• Development of study documentation, including CRFs, study reference manual, tracking logs, and regulatory binder
• Conduct initiation visits with investigative site personnel; preparation of initiation visit report
• Serve as primary contact and resource for study sites
• Work in conjunction with the Project Manager on monitoring strategy and monitoring schedule
• Monitor site source documents, CRFs and/or EDC for accuracy, completeness, and compliance with GCP, ICH guidelines, and protocol requirements.
• Monitor site regulatory documentation for accuracy, completeness, and adherence to all federal requirements
• Maintain close communication with sites to track recruitment and enrollment
• Ensure that investigative sites have adequate clinical supplies to meet study needs
• Identifies areas in which resources or progress are not consistent with the project plan and in the formulation of corrective action plan
• Communicate up-to-date information regarding study progress to all relevant parties
• Responsible for study close-out visit and follow up on data query resolution
• Attendance at Investigator Meetings as needed, attendance at other meetings with sponsors or their agents as needed
• Contribute to training activities for team members or investigative sites
• Participate in clinical training programs and maintain awareness of developments in the field of clinical research
Other clinical research duties as required