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Position Name :

Clinical Research Associate

Organization :

MedPace

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences, Ph.D

Experience:

0 YEARS / Freshers - 1 Year

Salary:

Not disclosed

Location:

Navi Mumbai, India

No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE® Training Program, you will join other Professionals Achieving CRA Excellence:

  • PACE® provides the platform to effectively and confidently carry out your duties, enhance your current abilities, and ultimately help you become a high-functioning independent Medpace CRA.
  • PACE® will prepare you by developing your CRA skills through interactive discussions and hands-on job-related exercises and practicums.
  • To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.

Unexpected Rewards

This role takes you on a journey through travel and excitement, allowing you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages, including:

  • Dynamic working environment with varying responsibilities day-to-day
  • Expansive experience in multiple therapeutic areas
  • Work within a team of therapeutic and regulatory experts
  • Defined CRA promotion and growth ladder with potential for mentoring and management advancements
  • Competitive pay and opportunity for a significant travel bonus

Responsibilities

As a CRA Entry, you will specifically be responsible for the following:

  • Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
  • Communicate with the medical site staff, including coordinators, clinical research physicians, and their site staff.
  • Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
  • Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to, and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
  • Verify that the investigator is enrolling only eligible subjects.
  • Review regulatory documents.
  • Manage medical device and/or investigational product/drug accountability and inventory.
  • Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
  • Assess the clinical research site’s patient recruitment and retention success and offer suggestions for improvement.
  • Complete monitoring reports and follow-up letters, which include providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Application Link

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