Job Group MR/9
Job Description: The Study Coordinator will be responsible for the coordination of a clinical trial titled “Antibiotics for Children with Severe Diarrhea (ABCD) Trial”.
She/he will work together with an Assistant Study Coordinator to manage the project on a day-to day basis from early stage initiation stage through study close-out.
She/he will work with Study Investigators to prepare and submit regulatory authority documents, design and edit appropriate logs to document study-related activities, conduct internal monitoring to ensure all protocols are being followed, conduct community outreach activities, and lead regular in-house trainings.
She/he will also manage staff members at five to six enrollment sites in western Kenya and ensure that all research processes strictly adhere to regulatory requirements.
She/he must communicate regularly on phone and email with Nairobi and Seattle based members of the study team and lead weekly study calls.
Qualifications
Degree in Nursing or Public Health or Degree or Higher Diploma in Clinical Medicine Nursing or Public Health with at least 5 years of experience in infectious diseases related research activities
At least 5 years experience coordinating research studies; clinical trial experience is preferred
Experience in coordination of multiple sites and teams
Experience in coordinating externally monitored studies
Be able to design, amend and implement research protocols
Ability to manage and supervise a large and diverse team of study personnel
Ability to communicate effectively and frequently to domestic and international supervisors in person, over the phone, on Skype, and over email.
Computer literate (Word, Excel, PowerPoint, email)
Excellent communication and organizational skills
Able to multi-task
Be a team player
Highly detail oriented
Willing and ready to travel within country on a regular basis
Must have Certificate of good conduct
Must have KRA Certificate of Tax compliance
Must have Clearance Certificate from HELB
Must have credit reference Bureau Certificate
Responsibilities
The clinical study coordinator will act as the primary point person for the study and will oversee all study activities including but not limited to:
Scheduling and managing all staff members at various study sites, training new staff members including giving briefings on all operational policies and procedures; ensuring each person understands his/her role and responsibilities
Set up and manage enrollment sites at various health facilities in Homa Bay and Migori Counties
Act as a liason between members of hospitals, Ministry of Health, and communities including conducting regular study sensitization sessions and discussion forums
Maintain strong relationship with study clinical sites and community groups involved
Review and provide input on standard operating procedures
Ensure compliance to standard operating procedures and best practices for the study
Develop and maintain quality control and assurance checks for study procedures and data
Attend and organize training of study procedures
Ensure all data and adverse event forms are filled out appropriately and in a timely fashion
Observation of study procedures to ensure adherence to protocol
Maintenance of Trial Master File and all quality control documentation
Responsible for all ethical and pharmacy review board applications
Coordinate staff evaluation procedures
Make weekly reports on the administration of the study
Fill-in for site staff members when necessary
Act as a liaison between site staff members and Nairobi and Seattle based study leadership through regular communication with both site staff and study leadership
Lead weekly study calls with the leadership team in Nairobi and Seattle
Perform other duties that may be given by the Study Investigators
Uphold the mission and vision of KEMRI/UW Organization
Terms Of Employment: One year renewable contract as per KEMRI scheme of service and a probation period for the first 3 months. The successful candidate shall be based in Nyanza.
Remuneration: Compensation is negotiable within a relevant grade, based on educational levels, relevant experience and demonstrated competency. The salary scheme is based on the KEMRI salary scales. Health Insurance Cover is provided for the staff members only.
