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Research Associate - Clinical Trials Unit

1.00 to 10.00 Years   Pakistan   11 Nov, 2023
Aga Khan University
1 Jobs Openings
Job LocationPakistan
EducationNot Mentioned
SalaryNot Mentioned
IndustryOther Business Support Services
Functional AreaNot Mentioned

Job Description

Research Associate, ClinicalTrials UnitEntity: AgaKhan UniversityLocation: Karachi,Pakistan.Introduction to the Aga Khan University: The Aga Khan University is a private,international university committed to international standards of excellence inteaching, research and service. Its teaching hospital, the Aga Khan UniversityHospital has been accredited by the prestigious Joint Commission Internationalfor achieving the highest international healthcare standards.Job Role / Responsibilities:You are required to:

  • develop/maintain very goodunderstanding of the study protocol and related study instruments
  • liaise and coordinate studyrequirements with relevant units and departments of the institution, in linewith AKU institutional policies
  • perform clinical assessmentand provide medical care the study subjects i.e., initial subject screening foreligibility, prescribing study medications, ongoing assessment and follow upsetc
  • organize and/or administerthe informed consent process in conjunction with the PI
  • coordinate and providepatient care in compliance with protocol requirements specific to patientsscreening, recruitment, scheduling, and study visit procedures
  • maintain study documentationas per protocol and GCP requirements (screening, subject recruitment,investigational drug accountability, enrolment, monitoring and study visit,adverse/serious adverse events etc.)
  • review/monitor patients forchanges such as in health status, response to investigational product, adverseevents, compliance in use of investigational product, concomitant medicationuse, protocol compliance
  • provide laboratory supportservices including phlebotomy and collection/handling of required specimens(e.g. stool, urine, nasal swabs) using standard techniques
  • maintain strict patientconfidentiality according to institutional regulations and applicable law
  • schedule and participate inrelevant sponsor/other monitoring / audits and activities as directed
  • assist in preparing (asrelevant) and maintaining regulatory and administrative study documents inaccordance with applicable regulations, institutional requirements and ICH GCPguidelines
  • communicate with and updatethe study investigator(s), regularly with respect to patient progress, healthstatus and any issues; as well, with study sponsors, relevant institutionalstaff, faculty, and clinical monitors to ensure effective clinical trialimplementation and progress
  • assist the PI inmanaging˙ and reporting SAE,annual/periodic reports for Ethics Committee and sponsor
  • facilitate all start-up andclose out requirements of the study.
Eligibility Criteria / Requirements:You should have:
  • excellent clinical skills
  • sound working knowledge & proficiency in human clinical trial processes, good clinical practices (ICH-GCP) & human research regulatory requirements
  • excellent interpersonal & communication skills
  • strong critical thinking abilities, organizational and management skills
  • proficiency in the use of computers and related Office software.
Disclaimer:The Aga Khan University is committed to the principles of equal employment opportunity for all employees and to providing employees with a work environment which is free from discrimination and harassment. All employment decisions at AKU are based on business needs, job requirements and individual?s qualifications and experience, without regard to race, colour, caste or creed, national, social or ethnic origin, gender (except where gender is a bona fide occupational qualification). AKU does not discriminate among the job candidates on account of any of these characteristics.

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