The Women’s Health Project
Position: Research Coordinator
Supervisor: Clinical Trials
Lead
Employment Type: Contract
The Women’s Health
Project
The Women’s Health Project, established in 1993, is a collaborative effort of the University of Nairobi (UoN), the University of Washington (UW), the Kenya Medical Research Institute (KEMRI), Mombasa County and the Fred Hutchinson Cancer Research Center (FHCRC), and the US President’s Emergency Program for AIDS Relief (PEPFAR).
Objectives
· To provide high quality
care to at-risk and HIV-positive women participating in the high-risk women’s
cohort (Mombasa Cohort).
· To conduct innovative
prevention and treatment research that will contribute substantially to local
as well as global knowledge and implementation of effective interventions.
· To conduct clinical
trials according to ICH-GCP and deliver quality services, products and devices.
Job Summary:
The Research Coordinator will coordinate and be a custodian of
all Institution Review Board & Regulatory Affairs communications for all
studies in liaison with the trial lead, clinic section head, administration and
Laboratory.
This will ensure the documents are centrally managed and all
information regarding the multiple studies being conducted on site can be
retrieved with ease upon request by sponsor, Principal Investigator and other
authorized personnel.
She/he will also perform clinical duties pertaining to care of
participants and be an assistant to the trial lead role.
Duties and
Responsibilities:
· Maintain the
Investigator’s Site File in an organized manner, tracking all submissions,
resubmissions, renewal, termination, closeout and amendments to Ethics and
Regulatory authorities.
· Maintain and track all
trainings by Staff for example qualification certificates, licenses, CVs &
study specific trainings among others.
· Liaise with section
heads on submission of safety reports Ethics and Regulatory authorities.
· Application of sample
shipment requests and maintaining the documents.
· Participate in protocol
implementation such as training and quality aspects of the study.
· Have in-depth
understanding of the protocols and SOPs.
· Participate in SOP
development and QA audit tools.
· Occasionally perform QA
audits.
· Maintain and track the
GCP and HSL training certificates for timely renewal.
· Regularly communicate
with the Ethics and Regulatory authorities on pending approvals and feedbacks.
· Assist during
monitoring, auditing and inspections with necessary documents.
· Liaise with various
section heads for collation of documents of various studies.
· May mentor and coach new
peers as they assimilate into this role
· Perform clinical duties
as a research clinician.
· Participate as a member
of a leadership team that includes the PIs and heads of Administrative,
Clinical, Laboratory, and Community sections of the project.
· Any other duties
assigned.
Required Qualifications
and Experience:
· Diploma/Bachelor’s
Degree in Clinical Medicine and Surgery.
· Registration by the
relevant professional body- Clinical Officers’ Council of Kenya.
· Experience in Clinical
Research, HIV care and epidemiological studies.
· Training in Research Ethics,
including Human Subjects Protection.
· Training in Good
Clinical Practice.
· Experience in dealing
with Ethics and Regulatory authorities for at least 1-2 years preferred.
· Requires 2 years of
clinical research experience
· Experience leading
clinical trials of drugs/vaccines is an added advantage
· Requires good knowledge
of applicable clinical research regulatory requirements i.e., Good Clinical
· Practice (GCP) and
International Conference on Harmonization (ICH) guidelines.;
Skills &
Competencies:
· Problem solving –
Problem solving skills.
· Organization – Planning,
time management and prioritization skills
· Prioritization – Ability
to handle conflicting priorities
· Quality – Attention to
detail and accuracy in work.
· Results-oriented
approach to work delivery and output.
· Leadership – Good
influencing and negotiation skills.
· Good judgment and
decision-making skills.
· Effective mentoring and
training skills, fostering learning and knowledge sharing with colleagues.
· IT skills – Good
software and computer skills, including Microsoft Office applications.
· Collaboration – Ability
to establish and maintain effective working relationships with coworkers.
· Effective communication
– Ability to influence without authority.
How to Apply
Applicants who meet the specified requirements should send the
following documents to infouwkmsa@gmail.com
· Application letter.
· Detailed CVs with 3
referees.
· Copies of academic and
professional certificates.
· Pay slip and/or current
remuneration if applicable.
· Current practicing
license
Subject should read “Regulatory Officer”
Closing Date: 5.00PM on 25-11-2022
Only shortlisted candidates will be contacted.
