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Remote Women's Fertility Clinical Research Associate Iii

Global Channel Management, Inc
Global Channel Management, Inc
2+ years
$49 to $50 per hour
10 Sept. 18, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Remote Clinical Research Associate III

Requirements:

  • Work Schedule: Monday to Friday, either 7:00 AM - 3:30 PM or 8:00 AM - 4:30 PM EST.

Qualifications:

  • Bachelor’s degree (BS/BA).
  • Minimum of 2 years of site management and field monitoring experience.
  • Knowledge of applicable standards and regulations for clinical trials.
  • Excellent oral and written communication skills.
  • Strong planning skills with the ability to create and track detailed project plans.
  • Proven interpersonal, leadership, organizational, and effective time management skills.
  • Proficiency in Microsoft Word, Excel, and basic templates.
  • Ability to work independently and within a cross-functional team, effectively identifying and escalating site/monitoring-related issues to management in a timely manner.

Preferred:

  • Experience in women's fertility studies.
  • Experience with VD studies.
  • Familiarity with the Medidata RAVE system.

Duties:

  • Conduct site initiation, interim, and close-out monitoring visits.
  • Verify that required clinical data entered in the electronic case report form (eCRF) is accurate and complete.
  • Manage site communication and escalate issues to leadership as needed.
  • Apply query resolution techniques both remotely and on-site, providing guidance to site staff and driving queries to resolution within agreed timelines.
  • Regularly review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile its contents with the Trial Master File (TMF).
  • Ensure that the investigator/physician site is aware of the requirements for archiving essential documents according to local guidelines and regulations.
  • Document activities through confirmation letters, follow-up letters, and trip reports.
  • Provide site support throughout the study lifecycle, from site identification through close-out.
  • Attend and participate in internal meetings.

We look forward to your application!