Position Summary:
The position holder will be expected to provide clinical support to a clinical research team conducting an oral PrEP study and provision of reproductive health services to adolescent girls, young women and older women. In addition, they will provide oversight and leadership to the daily conduct ofclinical studies as a designee of the Principal Investigator.
Responsibilities
Provide training, mentoring and guidance to clinical staff in all aspects of trial conduct and project orientation to ensure compliance with protocols and guidance documents
Promote good clinical practice in the conduct of clinical studies and provide medical input at allstages of the project lifecycle
Ensure preparedness of staff and site for study implementation.
Participate in participant review and care, and in all study procedures as guided by studyprotocols.
Oversee all clinic and other study personnel performing study specific tasks and procedures.
Oversee regulatory submissions and approvals to local ethical review committees and liaise with other project managers to ensure timely submissions to international institutional review boards.
Maintain all study records including but not limited to, regulatory binders, study specific source documentation and other materials as required.
Monitors adverse events and reports them to the safety monitor as required.
Coordinates and facilitates monitoring and auditing visits, notifies appropriate institutional officials audits, responses to any findings and implements approved recommendations.
Act as liaison between investigators, participants and staff.
May perform other job related duties as requested or required
Qualifications
Degree in Medicine and Surgery (MBChB)
At least 3 year work experience as a Medical Officer
Previous management and leadership experience.
Experience in a clinical research setting is preferred
Demonstrated clinical competence.
Knowledge of clinical trial ethics and Good Clinical Trial Practice will be an added advantage
Licensure
Must have valid retention certificate from KMPDC
Other Required Skills
Excellent interpersonal skills.
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
Applicants should attach the following:
Apply via :
phrdrecruit@pipsthika.org
