Job Summary
The CRU Clinical Operations Manager (COM) is responsible for overseeing and managing the clinical operations of the research unit. This position involves leadership, coordination, and collaboration with interdisciplinary teams to ensure the successful implementation and conduct of clinical research studies. Additionally, all clinical personnel report to this position (lab, pharmacy, nursing).
Responsibilities
Clinical trial oversight, and development
The CRU Clinical Operations Manager (COM) will be responsible for the day-to-day clinical operations of the Clinical Research Unit.
Provide leadership and strategic direction for the clinical component within the unit and oversees nursing, pharmacy & laboratory components of clinical trials.
Oversee the planning, initiation, and execution of research studies in collaboration with principal investigators/designee and study teams.
Oversee all aspects of clinical care of patients on clinical trials - screening, consenting, sample collection, drug administration, ongoing care, and end of study documentation in line with the appropriate team members involved.
Protocol implementation, regulatory, & quality compliance
Ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Provide training to staff, as needed.
Collaborate with managers, investigators, and sponsors to implement and manage clinical aspects of study protocols and to ensure compliance with regulatory requirements.
Coordinate with AKUH,N managers and leadership to ensure compliance with institutional policies and JCI requirements.
Lead audits and inspections for all components related to clinical aspects of trials and of the Unit.
Improved quality metrics demonstrated through routine internal quality checks and monitoring visit reports.
Quality review of study tools for nurses, coordinators, laboratory, and pharmacy staff.
Clinical Assessments and interventions, safety monitoring and reporting
Provide guidance on clinical assessments, interventions, and procedures required by study protocols.
Review safety data (SUSARS, SAEs, Investigator Brochures) quarterly to analyze trends and identify learning gaps.
Oversee the monitoring and reporting of adverse events and safety concerns.
Ensure timely and accurate reporting to regulatory authorities and study sponsors
Leadership & Staff management
Provide leadership and line management to research nurses, study coordinators, pharmacy & laboratory personnel.
Plan and oversee workforce allocation, recruitment, onboarding, and retention to ensure adequate staffing aligned with study workload and unit growth.
Coordinate with AKUH,N counterparts to ensure alignment in role and responsibilities.
Establish clear performance objectives and conduct regular performance appraisals in line with institutional HR policies.
Identify and execute staff training and professional development needs.
Foster a culture of continuous quality improvement and teamwork.
Quality Assurance, training and education
Provide operational oversight for quality assurance processes across all Clinical Research Unit activities, ensuring high standards in clinical practice, data integrity, and study documentation.
Conduct routine quality checks and internal audits to ensure accuracy, completeness, and timeliness of clinical research documentation.
Provide strategic direction for capacity building and workforce development to support current and future research portfolios.
Lead in the planning of development, review of Standard Operating Procedures (SOPs) for clinical research operations.
Provide training and education to clinical staff on study protocols, GCP, and relevant procedures.
Stay updated on developments in clinical research and disseminate knowledge to the team.
Study Feasibility Assessments
Review new studies alongside Investigators to conduct feasibility assessments and review clinical trial protocols.
Budget Management
Contribute to the development and management of budgets related to clinical activities in clinical trials.
Monitor and control expenses clinical related resources and services.
Involvement in strategic planning and direction of the CRU
Support the Director of the Cancer Center with strategic planning for the CRU
Any other duties may be assigned from time to time
Requirements
Masters degree in any health fields (nursing, bioethics, clinical research, public health), or Bachelor degree in any health field (e.g., nursing, laboratory, pharmacy) with at least 7 years of clinical experience.
Knowledge of best practices in clinical research (CITI or similar training), including active participation in international organizations, such as AACI, CRI, SOCRA, ACRP or similar.
Must have a valid and active Nursing Council of Kenya (NCK) license
Advanced Cardiovascular Life Support certification is required.
Relevant Experience
Minimum 7 years of work experience in clinical research, of which at least 5 years should have been spent directly in clinical trials
Superior understanding of and making budgets
knowledge and experience in dealing with clinical, regulatory, laboratory, and pharmacy staff as it relates to clinical trials implementation.
knowledge and experience of going through and participating in audit and/or accreditation processes, as related to standard of care practices and/or research.
Sound working knowledge of Good Clinical Practices (GCPs), clinical trial processes, nursing patient care, biomaterials handling, health safety practices.
Proficiency in use of computers and basic office software (Outlook, MS Word, Excel, PowerPoint, etc.)
Personal Characteristics & Behaviours
Excellent interpersonal skills and communication both written and verbal
Strong leadership and management skills
Excellent organizational capabilities and ability to handle diverse set of tasks for multiple studies and clinics simultaneously
Maturity and ability to work independently
Versatility to work in a variety of related roles such as clinical/nursing care, patient services support, lab/bio-specimen processing, data management
Strong self-initiative while working as part of a team
Ability to handle stressful situations and meet deadlines
Ability to work in a multicultural environment
Excellent interpersonal skills