Job purpose
Provide leadership and support to the clinic team and ensure participants are managed good as per the study protocol and Standard Operating Procedures (SOPs)
Responsibilities for the Study Physician Job
Promote Good Clinical Practice in the conduct of clinical studies by adhering to study protocol requirements, protecting the rights and welfare of participants, assuring the integrity of data generated and directing the conduct of the clinical investigation according to regulations, SOPs and guidance documents;
Oversee clinic personnel performing study specific tasks and procedure;
Provide medical input at all stages of the project lifecycle that includes development of study protocols, study submission documentation (informed consent form, study recruitment, review of eligibility to study entry, reporting of adverse events, study closure and end of study report review and writing;
Ensure that a signed consent form is secured from and signed by the subject prior to the initiation of any study specific procedures;
Provide leadership, training, mentoring and guidance to clinical staff in all aspects of trial conduct and project orientation so that staff perform their duties in compliance with SOPs and guidance documents
Provide input into the development of communication plans, training presentation, Case Report
Forms (CRFs), source document worksheets, and other project-specific tools;
Ensure that clinic procedures relating to the safe-keeping and confidentiality of source documents and the tracking of sample use permissions are followed and maintained;
Assess study subjects and participate in medical decisions;
Development of SOPs to guide study personnel;
Any other duties assigned by supervisor;
Study Physician Job Qualifications
A degree in medicine
Licensure
Must have valid retention certificate from KMPDB
Competencies
Good IT skills
Team player
Excellent communication skills
Highly organized
Experience
Must have successfully completed one (1) year of internship
Must have three (3) years’ experience in a clinic/ hospital set up
Must have experience as a study physician within a clinical research environment
