Research Coordinator, Clinical Trials Unit

Location
Pakistan
Posted
Oct 16, 2020
Closes
Nov 14, 2020
Ref
147816
Organization Type
University and College
Hours
Full Time
Aga Khan University was established in 1983 as an international university with an objective to promote human welfare in general, and the welfare of the people in the countries in which it operates, by disseminating knowledge and providing instruction, training, research and service in the health sciences, education and such other branches of learning as the University may determine. Clinical Trials Unit (CTU) is a Department dedicated to develop a center of excellence for high quality and high impact clinical trials both nationally & internationally. The Department promotes AKU's vision by providing leadership, consultation and facilitation in different phases of clinical trials in compliance with the International Standards and Good Clinical Practice (GCP) guidelines.

The Aga Khan University invites applications for the position of Research Coordinator, Clinical Trials Unit.

Responsibilities

You will be responsible to:
  • develop/maintain very good understanding of the study protocol and related study instruments
  • liaise and coordinate study requirements with relevant units and departments of the institution, in line with AKU institutional policies
  • organize and/or administer the informed consent process to the study subjects
  • coordinate and provide care in compliance with protocol requirements specific to subjects' screening, recruitment, scheduling, and study visit procedures.
  • 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 study subjects 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; processing of specimens (shipment handling and preparation where applicable
  • maintain strict data confidentiality according to institutional regulations and applicable law
  • schedule and participate in relevant sponsor/other monitoring / audits and activities as directed
  • assist in preparing (as relevant) and maintaining regulatory and administrative study documents in accordance with applicable regulations, institutional requirements and ICH, GCP guidelines
  • communicate with and update the study investigator(s) regularly with respect to study subjects' progress, health status and any issues; as well, with study sponsors, relevant institutional staff, faculty, and clinical monitors to ensure effective clinical trial implementation and progress
  • train and supervise research assistants in completing the study data
  • facilitate all start-up and close out requirements of the study.


Requirements

You should have:
  • MBBS or BScN with 2 years relevant experience OR
  • MSc in Epidemiology and Biostatistics, Public Health, Nursing or any other health related field
  • current registration & be in good standing with your professional association
  • BLS and GCP certification with validity of 2 years (preferable)
  • sound knowledge & proficiency in human clinical trials processes, national and international regulatory guidelines (GCP, CIOMS, CFR, Helsinki, HIPPA, NBC, DRAP and ERC etc.), research ethics & human research regulatory requirements
  • proficiency in the use of computer applications, particularly MS Office
  • good interpersonal and communication skills
  • ability to work effectively in teams and establish harmonious working relations at the place of work
  • ability to manage time and prioritize tasks effectively
  • resilience and ability to cope with work pressure.

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