Research Associate- Paediatrics & Child Health -MC

Job Description

Research Associate, Department of Paediatrics & Child HealthOrganization: Aga Khan UniversityLocation: Karachi, PakistanIntroductionThe Aga Khan University was founded in 1983 as Pakistan?s first private university. Aga Khan University is a not-for-profit institution and an agency of the Aga Khan Development Network. Starting in 2000, the University expanded to Kenya, Tanzania, Uganda, United Kingdom and Afghanistan. AKU began life as a health-sciences university.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 in conjunction with the PI
• coordinate and provide patient care in compliance with protocol requirements specific to patients screening, recruitment, scheduling, and study visit procedures
• where relevant, the study coordinator may 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
• maintain strict patient 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 patient 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
• draft and report SAE, annual/periodic reports to regulatory bodies and sponsor
• facilitate all start-up and close out requirements of the study.

• must possess a degree in medicine, or Masters/Bachelors level in Nursing or in any relevant Health Field (e.g. D Pharm) with relevant clinical experience
• 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 (e.g. D Pharm)
• possess excellent clinical skills
• demonstrate sound working knowledge & proficiency in human clinical trial processes, good clinical practices (ICH-GCP) & human research regulatory requirements
• excellent interpersonal & communication skills
• demonstrate strong critical thinking abilities, Organizational and management skills
• demonstrate team work, maturity, ability to work independently and versatility to work in a variety of related roles such as clinical/nursing care, patient services support, lab/bio-specimen processing, data management
• excellent organizational capabilities and ability to handle diverse set of tasks for multiple studies, simultaneously
• proficiency in the use of computers and related Office software.

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