Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Trial Associate

Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom
0-5 years
Not Disclosed
10 May 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Trial Associate

Company:

Kelly® Science & Clinical

Type:

Part-time/Possible Full-time, Contract/Possible Direct Hire

Location:

Santa Clara, CA

Hours:

Approximately 20 hours per week (stronger candidates may be considered for full-time/direct hire)

  • Flexible hours
  • Onsite

Compensation:

$35.00 per hour

Employment Terms:

No C2C

Job Description:

The Clinical Trial Associate will support the Clinical Affairs department in the conduct of clinical research studies (IDE/Post-Approval/Post-Market) sponsored by a medical device start-up. This role involves assembling and distributing clinical study materials, maintaining the Trial Master File, collecting, filing, and tracking regulatory documents, tracking IRB/EC approvals and renewal dates, and managing device accountability and shipments. The position requires strong communication skills, the ability to work independently, and the ability to manage clinical projects in a fast-paced environment.

Responsibilities:

  • Update and maintain the study Trial Master File (TMF) and keep all study files current.
  • Manage device accountability activities, including shipping and receiving.
  • Prepare study materials for site initiation visits and ongoing study conduct.
  • Support document translations.
  • Provide support to sites and field monitoring personnel by shipping study supplies and updated binders/forms.
  • Assist with administrative activities related to Investigator and Coordinator Meeting logistics and materials.
  • Generate and maintain clinical affairs-related metrics.
  • Assist in the creation and/or submission of clinical study reports, regulatory submissions, publications, and presentations.

Qualifications and Experience:

  • Experience supporting a department.
  • Familiarity with Medical Device product trials and regulations; working knowledge of GCP is a plus.
  • At least 1 year of experience with Trial Master File support.
  • Exceptional time management skills; ability to multi-task and prioritize.
  • Advanced oral and written communication skills.
  • Ability to work independently and with teammates.
  • Good problem-solving skills.
  • Excellent communication and interpersonal skills with the ability to maintain ongoing communications with department staff, clinical study site personnel, and other employees.
  • Personal attributes: independent, decisive, accurate, detail-oriented, multi-tasking, organized, and flexible.

Additional Qualifications:

  • Associate’s Degree/College Diploma desired; Bachelor’s degree in health sciences or related field preferred.
  • Proficiency in Microsoft Office.

Employer-Provided Information:

  • Pay range in Santa Clara, CA: Exact compensation may vary based on skills, experience, and location.
  • Base salary: $35/hr

If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.