Clinical Trials Specialist

3 days ago

Karachi, Sindh, Pakistan beBeeResearch Full time
Job Description

The Research Associate will be responsible for coordinating study requirements, organizing informed consent processes, and providing patient care in compliance with protocol requirements.

  • Liaise and coordinate study requirements with relevant units and departments of the institution.
  • Organize and 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.
Required Skills and Qualifications

Applicants must have a degree in Medicine, or Masters/Bachelors level in Nursing or in any relevant Health Field, and 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 in English.
  • Integrity and strong research ethics.
  • Efficiency in MS office tools (Microsoft Word, Microsoft PowerPoint and Microsoft Excel).
Benefits

This is a grant-funded contractual position.

Others

Comprehensive employment reference checks will be conducted.

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