Position Description:
The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements.
Position Responsibilities:
• Prepare and revise study materials and/or training
• Conduct training of site and/or Medtronic staff
• Assist in site initiation activities (e.g. study start-up documentation preparation)
• Set-up and maintain accurate progress and study status tracking logs
• Assist in the preparation of reports, regulatory submissions, publications and presentations
• Assist in the preparation of budgets and project plans
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities
• May arrange conference calls, staff meetings, and training events.
• Assist in the preparation and review of data
• Oversee follow-up and resolution of sites issues
• Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines
• Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks
• Contribute to process improvement initiatives and participate in training to enhance knowledge
Basic Qualifications:
• Bachelors degree
• 4+ years’ experience in clinical research (Masters degree will substitute for 1 year experience)
Desired/Preferred Qualifications:
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies
• Proficient knowledge of medical terminology
If you are interested and want to apply, please contact:
Ebrahim Sayarwala
ebrahim.sayarwala(at)collabera.com
973-854-9128
Job details are sourced from the employer's original posting.
Open job postingAbout the company
We provide cost-effective, high quality IT resources to meet talent needs through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera has been a leader in IT staffing for over 24 years and is one of the largest diversity IT staffing firms in the industry. We are known for our high-touch, customer-centric approach, offering our clients unmatched quality, responsiveness and flexibility. We are appreciated by our clients for our streamlined execution, highly efficient service and exceptional talent management that go above and beyond traditional staffing services. Collabera has been named the Best Staffing Firm to Work For in the large firm category by Staffing Industry Analysts, the global advisor on contingent work, for four consecutive years.