Clinical Research

Job Title

  • Clinical Research Associate (CRA)
  • Clinical Monitor
  • Trial Monitor

Educational Background

  • B.Sc.

Job Functions

Clinical trial associate (CRA) participate in setting up and monitoring the different phases of clinical trials of drugs. CRA conducts pre-study, study initiation, routine monitoring and close out visits to the clinical trial site.

Job Responsibilities

  • Write clinical trial protocols.
  • Visit various clinical trail sites, evaluate the sites and identify potential sites and brief appropriate trial investigators the clinical trial protocol.
  • Establish a clinical trial site and initiate and monitor the trial and close the site down once the clinical trial is completed.
  • Maintain appropriate documentation as needed
  • Visit the trial site regularly to monitor and then write visit reports.
  • Support the development of subject recruitment plans.
  • Responsible for recruiting of study participants, obtaining informed consent, protecting subject confidentiality and updating subject information.
  • Consult with the appropriate committee/ department regarding rights, safety and well being of trial subjects
  • Train the site staff on any study related training such as on the therapeutic area, protocol requirements, case report form completion, sponsor policy and procedures, investigator responsibilities
  • Administer the study protocol to the assigned sites and verify the drug product has been dispensed and administered according to the protocol.
  • Evaluate the quality and integrity of site practices and take appropriate actions towards any quality issues and escalate the issue if needed.
  • Responsible for sourcing and managing the required trial materials and drug products.
  • Comply with company’s standard operating procedures (SOPs) and regulations and guidelines.

Must Have Skills

  • Strong communication (verbal and written) and interpersonal skills.
  • Knowledge of applicable clinical research regulatory requirement
  • Familiarity with required medical terms
  • Able to follow regulations and guidelines, work independently and with accuracy, set priorities and think critically.
  • Must be comfortable traveling regularly
  • Committed to well being of subjects, customer service and team work

Type of Companies that hire

  • Pharmaceutical
  • Biopharmaceutical
  • Biotech
  • Clinical Research Contract Organizations

Competitive Advantage

  1. Competitive Advantage: certificate/ diploma on Clinical Research Associate Program
  2. If you are not able to land a Clinical Research Associate job, try Clinical Research Technician, Clinical Research Coordinator, Medical Transcription or similar roles and with this experience, apply for Clinical Research Associate position.

Career Growth

Clinical Research Associate –> Senior –> Project Manager –> Director/ VP (Ph.D.)

Clinical Research Associate –> Clinical Research Scientist (Ph.D.)

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