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Associate Clinical Research Iii

6+ years
$83,600.00 – $167,200.00
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here's a summary of the Associate Clinical Research III position at Abbott:


Organization:

Abbott


Position Overview

Abbott is seeking an Associate Clinical Research III to assist in the execution and management of clinical studies. This role involves planning, implementing, and overseeing clinical studies from concept to report, ensuring they meet quality standards and timelines. The Associate Clinical Researcher will work on both internal and external clinical studies, focusing on diabetes management technologies, and supporting the development of new sensing technologies.


Key Responsibilities

  • Clinical Study Management: Design, execute, and monitor internal clinical studies. Participate in planning and implementing external clinical studies (e.g., PMA and outcome studies).
  • Study Site Monitoring: Conduct site visits (SQV, SIV, IMV, COV) to ensure compliance with study protocols, Good Clinical Practices (GCP), ICH guidelines, and applicable regulations.
  • Study Documentation and Communication: Prepare and maintain Trial Master File (TMF), clinical protocols, reports, and other documents. Communicate study outcomes to cross-functional teams.
  • Training and Development: Participate in training and qualifying clinical sites, investigators, and case report forms (CRFs). Assist in the design of studies and the selection of investigators.
  • Data Review and Submission Preparation: Review clinical data for accuracy, escalate issues as needed, and support interim and final data reviews for regulatory submissions.
  • Study Device Accountability: Ensure shipment and accountability of study devices and supplies.

Required Qualifications

  • Education: BS in Life Sciences or a related field.
  • Experience: 6 years of experience as a CRA or CRC (Clinical Research Associate/Coordinator) or a combination of education and relevant experience.
  • Clinical Trial Experience: 3+ years of experience in clinical site monitoring and understanding clinical trial practices, especially in medical device and in-vitro diagnostics studies (pharmaceutical experience also considered).
  • Skills: Strong teamwork, interpersonal, and communication skills. Solid understanding of clinical trial processes, data management, and regulatory requirements.

Salary Range

  • Base Pay: $83,600.00 – $167,200.00 annually (may vary by location).

Benefits

  • Health Investment Plan (HIP) PPO: Free medical coverage for employees who complete a wellness assessment.
  • Retirement Savings Plan: High employer contribution.
  • Tuition Reimbursement and Education Benefits: Including Freedom 2 Save student debt program and FreeU education benefit.
  • Other Benefits: Abbott offers a comprehensive health and wellness benefits package to help employees and their families live full lives.

Company Overview

Abbott is a global leader in healthcare, creating breakthrough science and technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. Abbott has a strong focus on helping people live fuller, healthier lives, particularly in the area of diabetes management through innovative products.


Abbott offers an excellent opportunity to be part of a dynamic healthcare company that drives innovation and works towards improving lives worldwide.