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Clinical Project Manager/Sr. Clinical Research Associate

Company

TalentZök
Address Carlsbad, CA, United States
Employment type FULL_TIME
Salary
Category Staffing and Recruiting
Expires 2023-05-21
Posted at 1 year ago
Job Description
- Simply Biotech
Overview
Are you looking for a new career opportunity with an exciting company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Clinical Project Manager/Sr. Clinical Research Associate in Carlsbad CA who possesses:
  • Minimum: Bachelor's degree
  • Available for domestic travel 5-10 days per month.
  • 3-5 years clinical study management experience
Email resumes to [email protected] or call 858.487.0507
Responsibilities
FULL DESCRIPTION:
  • Manage invoices from contracted study sites and vendors.
  • Manage sites by tracking regulatory submissions/approvals, patient recruitment, case report form completion and data queries.
  • Daily field activities and communications with study sites (clinical investigators, research staff), Institutional Review Boards (local and central IRBs), and study sponsor (Clinical Affairs, Data Management, Accounting)
  • Evaluate quality and integrity of study site practices for adherence to protocol and applicable regulations including ICH and GCP.
  • Manage clinical operations for post-market observational registry at study sites in the US
  • Perform in-person site initiation and maintenance (site selection, training, monitoring, closeout)
  • Administer electronic data capture (EDC) system for data entry by study site staff.
  • Create and/or update study documents and materials including Case Report Forms, site and sponsor guidelines, site regulatory and subject binders, work instructions, and site contracts/budgets
  • Support clinical site and/or sponsor FDA audits as necessary.
Requirements
  • Institutional Review Board submissions and related materials (protocol, ICF, CRFs, etc.)
  • Minimum: Bachelor's degree
  • User/administrator experience with clinical Electronic Data Capture
  • Minimum: 5 years clinical study management experience
  • GCP trainined
  • Spine surgery or orthopedics study experience a plus
  • Available for domestic travel 5-10 days per month.
Hourly Wage Range $33-$43/hr
For immediate and confidential consideration, please email your resume to [email protected] or call 858.487.0507
More information can be found at www.TalentZok.com