KEMRI Administrative Assistant - Isiolo Jobs in Kenya
Key Responsibilities: Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Oversees scheduling of study participant appointments and serves as the patient liaison to the PI and other participating clinicians
Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
Support development of clinical study budgets based on proposed study protocols.
Coordinates and attends sponsor and monitor visits
Responds to data clarification requests in a timely manner.
Participate in Investigator meetings requiring travel and report pertinent information back to research team members.
Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
Maintains records and other documentation of training.
Maintains subject screening logs and protocol deviation logs.
Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical studies.
Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.
Ensures that all materials for each clinical trial protocol are available for subject enrollment
Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that
there is timely documentation and submission of study data.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer
May perform other job related duties as requested or required Knowledge of program management
Oversees regulatory submissions and approvals to local and international institutional review boards or ethical review committees
Familiar with the diverse needs of clinical studies
Vacancy Requirements:
1 Bachelor’s degree in Health Sciences (Medicine, Nursing, Pharmacy, Public Health) (Mandatory)
2 Minimum two years’ experience as a Clinical Research Coordinator, with a preference for candidates with experience in HIV and Reproductive Health research. (Mandatory)
3 Strong knowledge of cervical cancer, including prevention, diagnosis, and treatment protocols. (Mandatory)
4 Knowledge of clinical trial ethics and Good Clinical Trial Practice (Mandatory)
5 Excellent interpersonal skills to deal effectively with clinicians, other study staff, participants, administrators, regulators, monitors and sponsors. (Mandatory)
6 Familiarity with the Microsoft Office Suite. (Mandatory)
7 Excellent organizational skills to independently manage work flow. (Mandatory)
8 Ability to prioritize quickly and appropriately (Mandatory)
9 Ability to multi-task. (Mandatory)
10 Meticulous attention to detail (Mandatory)
How to Apply
For more information and job application details, see; KEMRI Administrative Assistant - Isiolo Jobs in Kenya
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