Research Medical Officer, Clinical Research Unit

Research Medical Officer

Department
Clinical Research Unit

Entity
Aga Khan University

Location
Nairobi, Kenya

Introduction

Chartered in 1983, Aga Khan University (AKU) is a private, autonomous, and self-governing international university, with 13 teaching sites in 6 countries over three continents. An integral part of the Aga Khan Development Network, AKU provides higher education in multiple health science and social science disciplines, carries out research pertinent primarily to low- and middle-income countries and operates 7 hospitals (soon 8) and over 325 outreach clinics, all at international standards. It has almost 2,500 students and 14,000 staff. The University is both a model of academic excellence and an agent of social change. As a leading international institution dedicated to excellence and change, AKU operates on the core principles of quality, relevance, impact, and access.

Job Summary

The Research Medical Officer is:

·       Responsible for working closely with the CRU Director and Managers on coordinating clinical care, documentation, and study compliance of research study participants.

·       Responsible for the provision and facilitation of clinical care to study participants alongside study Investigators, as well as continuous evaluation and monitoring of participants to ensure safety, study compliance, and Good Clinical Practice (GCP).

·       Involved with coordinating clinical care, documentation, and patient management within Department of Haematology-Oncology, as required.

·       Involved with Cancer Centre initiatives, as required.

Responsibilities

• Responsible for working closely with the CRU Director and Managers on coordinating and implementing the clinical care, documentation, and study compliance of research participants.
  • Involved in CRU meetings, feasibility assessments, audits, and monitoring, close-out, and study initiation visits
  • Review of clinical and non-clinical study documents
  • Discuss and escalate study and patient updates and queries with CRU team members
  • Share regular activity reports (patient and study specific) with CRU leadership (managers, director, etc.)
• Responsible for the facilitation and provision of clinical care to research study participants, as well as continuous evaluation and monitoring to ensure safety, study compliance, and GCP. Involved with coordinating clinical care, documentation, and patient management within Department of Haematology-Oncology, as required.
  • Recruit and/or screen participants from referrals/tumour boards (or equivalent), and evaluate potential eligibility
  • Extensively involved in the consenting process
  • Review all eligibility documentation and check for eligibility per protocol alongside leadership (study lead, Investigators)
  • Provide thorough documentation of activities conducted and overall visit summaries timely and accurately, as per GCP, AKUHN and site requirements
  • Evaluation and management of study participants/patients to provide high-quality clinical care:
    • Review and examine patients as required for visits (e.g., taking case histories, conducting physical examinations, ordering diagnostic laboratory/radiology studies)
    • Attend to patients/participants in a timely manner
    • Monitor patients/participants progress on a regular basis
    • Ensure compliance with protocol required assessments and documentation
    • Perform clinical procedures as part of protocol requirements (I/V cannulation, ECG, etc.)
    • Address and escalate clinical issues and symptom management of participants/patients in collaboration with Investigators/lead doctors
    • Reporting of adverse reactions and protocol deviations timely per GCP and site requirements
    • Appropriate and timely initiation and facilitation of escalation of care/care-pathways
    • Liaising with consultants and various departments to ensure timely and relevant discussions as part of patient management
  • Counselling and Education: Patient/family/care-giver education to ensure protocol adherence and ensure participants’ rights, welfare, and safety are upheld
• Work collaboratively with the leadership team to manage clinical care and study compliance of patients/participants
• Participate in the review and development of appropriate policies and procedures for patient care to formulate best practice guidelines
• Participate in the meticulous use of resources to enable patient safety and quality care
• Involved with grants, abstracts, presentations, and publications initiatives within the Departments (literature review, grant preparation, costing, budgeting, etc.)
• Actively involved in quality improvement & patient safety activities (e.g., a) review, presentation and action plans tied to SUSARs and SAEs; b) Lead training and drills for team alongside Clinical Operations and Nurse managers).
• Perform other duties as may be assigned by department supervisor/manager.

Requirements

·       Bachelor of Medicine and Bachelor of Surgery (M.B.Ch.B)

·       Registration by the Kenya Medical Practitioners and Dentist Board

·       Valid ACLS

·       Preferred: CITI Good Clinical Practice and Human Subject Research training and certificates

Relevant Experience

·       At least 2 years post internship experience (3 years, including 1 year of internship)

·       Strong knowledge of medical terminology, drug calculation skills, and clinical medicine

·       Excellent documentation practices

·       Preferred: Prior experience in human subject therapeutic research and/or involvement with research trials involving investigation agents

·       Preferred: Clinical background in emergency medicine, oncology, neurology, rheumatology

Personal Characteristics & Behaviours

·       Demonstrates competency and dexterity with all equipment utilized in the hospital environment

·       Good communication skills

·       Strong self-initiative while working as part of a team

·       Ability to handle stressful situations and meet deadlines

·       Demonstrates honesty, integrity, compassion, and respect for diversity and applies ethical principles appropriately

·       Seeks and accepts advice

·       Punctual and respects commitments made

·       Good patient care and support skills

·       Organized and ability to handle diverse set of tasks for multiple studies and clinics simultaneously