Clinical Trials Specialist

3 days ago

Karachi, Sindh, Pakistan beBeeResearch Full time 1,543,900 - 2,356,500
Job Title:

Research Associate, Clinical Trials Unit

About the Role:

This role requires a highly skilled and motivated individual to join our team as a Research Associate in the Clinical Trials Unit.

Key Responsibilities:
  • Liaise and coordinate study requirements with relevant units and departments of the institution, in line with institutional policies.
  • Organize and/or administer the informed consent process in conjunction with the Principal Investigator.
  • Coordinate and provide patient care in compliance with protocol requirements specific to patients screening, recruitment, scheduling, and study visit procedures.
  • Disburse investigational product upon written authorization from the PI and provide relevant teaching with respect to its administration.
  • Maintain study documentation as per protocol and GCP requirements (screening, subject recruitment, investigational drug accountability, enrolment, monitoring and study visit, adverse/serious adverse events etc.).
  • Review/monitor patients for changes such as in health status, response to investigational product, adverse events, compliance in use of investigational product, concomitant medication use, protocol compliance.
  • Provide laboratory support services including phlebotomy and collection/handling of required specimens (e.g. stool, urine, nasal swabs) using standard techniques.
  • Review clinical trials protocols and share feedback with supervisors for approval.
  • Facilitate internal and external audits of the unit.
  • Draft and report SAE, annual/periodic reports to regulatory bodies and sponsor.
Requirements:
  • A degree in Medicine, or Masters/Bachelors level in Nursing or in any relevant Health Field.
  • Must have a current registration & be in good standing with their professional association.
  • At least one-year research experience with MBBS or 3 years clinical work experience in nursing or other.
  • Possess excellent clinical skills.
  • Ability to work independently and versatility to work in a variety of roles.
  • Excellent written and verbal communication skills.
  • Integrity and strong research ethics.
  • Efficiency in MS office tools (Microsoft Word, Microsoft PowerPoint and Microsoft Excel).

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