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Sr. Clinical Research Associate

10 Oct. 7, 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

Position: Senior Clinical Research Associate
Location: Bangalore / Delhi / Ahmedabad / Mumbai / Hyderabad
Department: Clinical Services – Clinical Operations - Monitoring & Site Management
Employment Type: Full-time, Permanent / Remote

Company: Alimentiv


About the Role:
We are seeking a Senior Clinical Research Associate (Sr. CRA) to join our dynamic team at Alimentiv. In this role, you will play a crucial part in overseeing and managing clinical trials, ensuring compliance with regulatory standards and protocols. You will work closely with sites and internal teams to facilitate the smooth execution of clinical studies.

Key Responsibilities:

  • Conduct site qualification, initiation, monitoring, and close-out visits, both on-site and remotely, ensuring compliance with GCP, ICH guidelines, and study protocols.
  • Evaluate site performance and provide recommendations for improvement, promptly communicating any serious issues to the project team.
  • Review informed consent processes, ensuring proper documentation and adherence to patient confidentiality standards.
  • Perform source document verification and ensure the accuracy and completeness of clinical data entered into case report forms.
  • Collaborate with site personnel and cross-functional teams to support patient recruitment and retention efforts.
  • Maintain accurate documentation of site activities, including trip reports and communication logs, in accordance with company SOPs.
  • Prepare for and participate in sponsor meetings and investigator meetings, providing insights on site performance and study progress.

Qualifications:

  • Bachelor’s degree in a related field or equivalent combination of education and experience.
  • Prior experience as a Clinical Research Associate with a strong understanding of clinical trial processes and regulatory requirements.
  • Excellent communication, organizational, and interpersonal skills.
  • Ability to manage travel effectively, as required for site visits.

Why Join Alimentiv?
At Alimentiv, we are dedicated to advancing clinical research and improving patient outcomes. Join our team of passionate professionals and make a meaningful impact in the world of clinical trials.