Sr Clinical Research Specialist

Sr Clinical Research Specialist

Collabera Inc (Staffing Firm).

We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World’s ‘Most Admired Companies to work for’.

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

Qualifications

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

Additional Information

If you are interested and want to apply, please contact:

Ebrahim Sayarwala

ebrahim.sayarwala(at)collabera.com

973-854-9128