Description
Position Title: endTB Site Coordinator
Reports to: PIH Lesotho MDRTB Director/endTB Central Team Study Coordinator
Location: Maseru, Lesotho
Mission and Responsibilities
The Site Coordinator (SC) will bring clinical research expertise and be responsible for coordinating the implementation of endTB clinical trial at the participating site. The SC will support Site Principal Investigator (PI) to facilitate and oversee day-to-day operations of the study including identifying and securing needed resources; coordinating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines and goals are attained; monitoring and reporting progress as appropriate; resolving or escalating issues in the conduct of the study to ensure compliance with the International Conference of Harmonization Good Clinical Practice (ICH-GCP), study protocol, and all applicable regulatory and Ethics Committee requirements. S/he will work closely with the site(s), the central research team, the PIH program(s) and all relevant institutions and departments on the site level (e.g. Ethics Committee and Regulatory Authorities).
The SC will:
Be familiar with and understand the ethical standards and regulatory obligations that govern human subjects’ research
Ensure the protection of the rights, safety, and welfare of all study participants and safety of study staff
Support the Site PI in study start-up activities, including regulatory and ethics committee application, budget development, staff recruitment
Maintain staff education and training records in GCP, applicable regulations that govern the research activities, as well as the study protocol andeffective operating procedures
Oversee completion of study activities per enrollment goals
Provide assistance to ensure that the study is planned, set up, conducted, documented and reported according to GCP, applicable regulations, the protocol and effective standard operating procedures (SOPs)
Ensure the study protocol are in compliance with appropriate rules and regulations
Act as liaison between study sponsor, collaborating organizations and/or other research and/or education institutions
Coordinate and participate in budgetary negotiations with involved parties
Ensure that site trial staff adheres to the study procedures, verification procedures, audits and inspections procedures
Collaborate and support the Site PI in preparation and timely submission of reportable adverse events to the MSF Pharmacovigilance Unit, central research team, local authorities, and relevant ethics committees
Be responsible of site budget development and payment request submission
Main activities
Prior to initiation of the trial, the Site Coordinator will:
Review and ensure conformity with local requirements and GCP requirements all trial documents relevant to the site, including the study protocol, case report form (CRF), the patient information leaflet, informed consent form (ICF) etc.;
Support the Site PI in preparation of documents to obtain study approval from all local relevant authorities, and forward notification to responsible personnel in the Trial Central Team;
Initiate the Investigator Site File (ISF) and ensure all essential documents required for site initiation are forwarded to the Trial Master File (TMF);
Ensure that all study staff is trained in ICH-GCP, the protocol, and the effective operating procedures;
Ensure that the study drugs are available at dispensing site(s), stored under appropriate conditions, and accounted in accordance to study-specific requirements;
Ensure that quality assurances are in place according to the requirements from the laboratory coordinator from ITM (Antwerp, Belgium) for TB laboratories and with other laboratories for clinical lab tests;
Ensure completion of logistical preparation for the trial site.
During recruitment in the trial:
Provide support to clinical investigators with subject recruitment in accordance with protocol, effective SOP, GCP and applicable regulatory requirements;
Collaborate with the Site PI to ensure recruitment goals are attained;
Perform internal monitoring and quality assurance activities to ensure that study activities are compliant with GCP, applicable regulations, the protocol and effective SOPs;
Monitor study progress and submit monthly progress report;
Maintain proper training and education records of all site study team members;
Maintain the Investigator Site File (ISF);
Support the Site PI for the submission of any amendment to protocol or ICFs for approval to local NRA and EC bodies;
Ensure proper reporting of notifiable events to the MSF Pharmacovigilance unit and all relevant ethics and/or regulatory parties;
Ensure trial data completeness and quality is recorded and reported promptly on CRFs and subject confidentiality is maintained;
Coordinate study visits for all study participants;
Collaborate with study nurses, data manager(s) and other essential site study team personnel for the implementation of the endTB clinical trial;
Coordinate efforts with endTB observational study, as appropriate;
Be in constant communication with the Site PI, Central Team Study Coordinator for:
Study update
Safety issues
Any issue related to protocol deviation(s)
Any specific concern related to human specimen analysis
Any request of study related document amendment.
Requirements
Successful completion of at least a full 4-year course of study in an accredited university leading to a bachelor’s in social science or health science, plus five years of essential clinical research experience
Therapeutic trial experience, preferably in tuberculosis, as research assistant, study coordinator or study monitor. Clinical Research Coordinator Certification (CRCC) is desired, but not required
Comprehensive knowledge and understanding of ICH-GCP and clinical research regulations pertaining to human subjects protection
Project management experience desired
Must demonstrate superior communication, time management and problem solving skills
Proficiency in Microsoft Office applications and internet applications. Experience with electronic medical records and/or data capturing systems is desired
Good knowledge of English and local language(s) (desirable)
Partners In Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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