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: phrdrecruit@pipsthika.org