A Clinical Trials Research Group situated in Thika, seeks to recruit for the following position. The research studies conducted are mainly on HIV/AIDS area.
Program Manager / Site Coordinator
Program Manager / Site Coordinator
Job Purpose: The position holder will be expected to oversee the coordination of existing and upcoming clinical studies. They will provide oversight and leadership for the daily conduct of clinical studies as a designee of the Principal Investigator.
- 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
Education and Experience:
- A degree in health Sciences (Medicine, Nursing, Pharmacy, Public Health)
- Masters of Public Health or equivalent preferred
- Two years in a clinical research setting, preferably working as a clinical research coordinator
- Knowledge of clinical trial ethics and Good Clinical Trial Practice
Job Knowledge and Skills:
- Excellent interpersonal skills to deal effectively with clinicians, other study staff, participants, administrators, regulators, monitors and sponsors.
- Familiarity with the Microsoft Office Suite.
- Excellent organizational skills to independently manage work flow.
- Ability to prioritize quickly and appropriately
- Ability to multi-task.
- Meticulous attention to detail
Submit your application letter addressed to the Principal Investigator with your daytime telephone contact, telephone contacts of three professional referees, a detailed curriculum vitae 11th November 2016 to: firstname.lastname@example.org