Instagram
youtube
Facebook
2+ years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time 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

Company Description

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions in contract research focused on clinical trials for drugs, biologics, and medical devices. We offer exciting opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, collaborating with university hospitals, pharmaceutical companies, and recruiting partners.


Job Description

Position: Medical Monitor

As a Medical Monitor, you will be responsible for providing medical leadership and overseeing the safety of clinical trials. You will ensure compliance with protocols, support investigators, and ensure the safety of trial participants.


Responsibilities

  • Lead medical teams in the region, offering guidance to monitoring staff.
  • Develop and maintain expertise in compounds under development and relevant therapeutic areas.
  • Monitor the safety of subjects participating in clinical trials.
  • Select and manage clinical investigators, ensuring they meet trial requirements.
  • Handle Serious Adverse Event (SAE) Reports following standard operating procedures (SOPs).
  • Ensure timely distribution of IND reports to investigators and ethics committees.
  • Review and approve study budgets with site management teams.
  • Evaluate site monitoring reports to ensure safety standards are met.
  • Support Clinical Research Associates (CRAs) in ensuring sites comply with GCP and SOPs.
  • Strong communication skills to liaise with stakeholders and team members.

Additional Information

All candidate information will be kept confidential in accordance with EEO guidelines.