Senior Clinical Research Associate

Senior Clinical Research Associate

Job Title: Senior Clinical Research Associate
Contract Type: Permanent
Location: South San Francisco, California
Salary: Negotiable
Start Date: asap
Reference: HQ00055072_1500674780
Contact Name: Pavlina Bullaj
Contact Email:
Job Published: July 21, 2017 23:06

Job Description

Sr. Clinical Research Associate

San Francisco Bay Area

Urgently looking for a Sr. Clinical Research Associate with experience working on Medical Device trial. The client is a seeking a professional who can participate in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports; performing clinical on-site case support, site monitoring visits; and interfacing with site coordinators, Clinical Research Organizations (CRO), and other company representatives.

Essential Duties:

  • Ensure that documentation from investigators and investigational sites meets FDA/ ICH GCP/ISO 14155 requirements.
  • Assist in designing, planning, and implementing clinical research projects
  • Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
  • Review study records including case report forms, consent forms, and other materials.
  • Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements.
  • Organize data in systematic manner to allow for efficient and accurate clinical reports.
  • Perform site visits to ensure regulatory and study requirements are being fulfilled.
  • Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols; including surgical case coverage.
  • Assist in writing the clinical portion of Regulatory submissions.
  • Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
  • May oversee the work of Clinical Research Associate I, II and Clinical Trials Assistant.
  • Perform other clinical duties when requested.
  • Computer proficiency in Microsoft Office required.
  • Maintains trained status for, and complies with, all relevant aspects of the clients Quality Management System to ensure product quality and support regulatory compliance.
  • Understands and adheres to the clients Quality Policy.
  • Must be willing to travel up to 35 to 50% of time

Education & Experience:

  • Bachelor's degree in a scientific or health care discipline preferred and /or training
  • 5+ years' recent experience in the role of Clinical Research Associate
  • Four to six years' experience in the medical device industry with involvement in clinical research activities preferred.
  • Effective clinical monitoring skills
  • Excellent understanding and demonstrated application of GCP and applicable SOPs
  • Prior experience managing CRO's and study sites