The Women’s Health Project Research Coordinator Jobs in Kenya

The Women’s Health Project Research Coordinator Jobs in Kenya

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”

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