Instagram
youtube
Facebook

Senior Clinical Research Associate

3-5 years
Not Disclosed
12 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, 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: Senior Clinical Research Associate

Company: C2N Diagnostics

Location: Remote (St. Louis-based company)

About the Company:

C2N Diagnostics is a biotechnology company based in St. Louis, actively engaged in developing diagnostics for neurological disorders. They are committed to creating a diverse and inclusive workplace.

About the Role:

As a Senior Clinical Research Associate, you will play a crucial role in managing and executing clinical trials and studies focused on blood biomarkers for Alzheimer’s disease and other brain-health indications. This remote position will report to the Director of Clinical Affairs.

Responsibilities:

  1. Develop critical study documents such as protocols, case report forms, clinical reports, and informed consent forms.
  2. Lead database development activities for assigned projects, including UAT testing and interfacing with clinical sites.
  3. Manage site activation and study management activities, including site identification and relationship building with investigational sites, CROs, and IRBs.
  4. Lead Central IRB submission efforts, review local IRB submission packages, and ensure submission to local IRBs.
  5. Conduct remote and/or on-site visits for study preparation, monitoring, and data quality confirmation.
  6. Perform study data review activities to ensure compliance with protocols, regulations, and standards.
  7. Assist in creating SOPs and other quality documents supporting Clinical Affairs initiatives.
  8. Conduct trial master file reviews in preparation for audits.
  9. Contribute to planning activities and create meeting materials for investigator meetings and study oversight committee meetings.
  10. Represent Clinical Affairs and collaborate on inter-departmental project teams.

Qualifications:

  • 3-5 years of experience in medical device/IVD or drug clinical trial management.
  • Proficiency in GCP guidelines, ICH, and ISO standards governing clinical research.
  • Strong oral and written communication skills with attention to detail.
  • Self-motivated with the ability to take ownership of multiple tasks.
  • Willingness to travel up to 50% of the time, domestically and possibly internationally.
  • Valid driver’s license.

Physical Requirements:

  • Ability to sit and stand for up to four-hour periods.
  • Ability to lift up to thirty pounds in an office environment.

Featured Benefits:

  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave