Clinical Site Manager - Mbeya Tanzania - Africa
Our client is seeking a Clinical Site Manager to support the US Military HIV Research Program (MHRP) in Mbeya Tanzania.
The incumbent is responsible for being liaison on the ground for close follow-up of Military HIV Research Program (MHRP) activities in Mbeya, Tanzania. The incumbent will work
closely with the site PIs and key clinic staff in carrying out responsibilities and providing feedback on clinical research activities to key MHRP POCs. The incumbent will facilitate information flow between various MHRP departments and counterpart National Institute of Medical Research-Mbeya Medical Research Center (NIMR-MMRC) POCs at the clinical research site. He/She will assist site and MHRP staff with the evaluation, development, set-up, training and monitoring NIMR-MMRC site’s participation in MHRP and HVTN clinical research studies. The incumbent will provide support and technical input for project plans including timelines, related to clinical, laboratory, pharmacy and data management operations to integrate activities with clinical trials and studies.
Responsibilities Clinical Site Operations
• Conduct site qualification/evaluation on behalf of MHRP to assess feasibility to conduct studies/trials including review of staffing needs.
• Work with the MHRP Clinical Operations Office (COO) Clinical Trials Specialist to map out regulatory strategies.
• Facilitate the development, review and updating essential study documents and all aspects of documentation control and archiving.
• Facilitate the implementation and management of assigned clinical studies including but not limited to: review of protocols and site-specific addendums, informed consent documents, recruitment documents, CRFs and questionnaires, training manuals, MOPs.
• Develop and maintain liaisons with site PIs or designees to ensure proper and timely submissions to ECs and HAs, review and assist in preparation of appropriate responses for re-submission if necessary.
• Facilitate communications with MHRP COO to ensure all regulatory documents required for DoD reviews are submitted in a timely manner; ensure all follow up submissions required for compliance are taking place.
• Assist in preparation of study contact lists, workplans, study timelines and communication plans.
• Hands-on review/development of source documents and other study tools.
• Facilitate study mock-visits and other study start-up activities.
• Assist in ensuring staff training records are maintained to include GCP, HSP, updated CVs, protocol training, and all DAIDS and Sponsor required training documentation.
• Work closely with site PIs, site staff and protocol teams to ensure protocols and study related activities are conducted according to project timelines and in compliance with protocol and ICH GCP guidelines.
• Anticipate and identify study’s critical path and communicate priorities to protocol teams on the ground and MHRP.
• Review periodic study enrollment updates including recruitment, trial conduct and, if needed, identifying study-related problems and propose resolutions; update MHRP as required.
• Facilitate proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) and other reportable events per protocol as needed. Ensure SAEs, safety update reports and other new information or sponsor reports are provided to and received by the sites for reporting to ethics, as needed.
• Liaise with INLAP and site as needed to integrate lab activities with clinical trials and studies.
• Liaise with DCAC and site to ensure that data queries are resolved, and to anticipate, identify, and/or solve other data management problems.
• Liaise with pharmacist and protocol team to integrate pharmacy needs and requirements with clinical trial activities.
• Participate in MHRP site and protocol team calls.
Monitoring and Quality Assurance
• Assist site in preparing for upcoming monitoring and audit visits.
• Conduct COO co-monitoring visits as needed.
• Review monitoring and audit reports for tracking and trending of issues and escalate and participate in site training as required.
• Work closely with clinic teams to ensure timely and appropriate follow-up of issues raised by monitors and Sponsor representatives.
• Facilitate the development and/or updates to clinic quality management plans.
• Conduct internal monitoring/QA activities to include review of select participants charts and provide feedback to teams.
• Conduct internal regulatory reviews to ensure that regulatory documents are maintained and up-to-date and provide feedback to teams.
• Ensure clinic teams are conducting QC/QA activities and compiling required reports for submission as required by DAIDS and other Sponsors.
General
• Represent MHRP Clinical Directorate for any selected in-country collaborations as requested.
• Follow-up on any required MHRP Clinical Trials Unit activities to include follow up on requests from NIH/DAIDS or HIV Vaccine Trials Network with regards to budgets, annual report preparation, monitoring findings, protocol and participant safety related queries, among others.
• Facilitate and follow-up with site/study budget development as requested.
• Facilitate in gathering data needed for determining study supply needs.
• Facilitate site logistics planning to include but not limited to training, site visits, and travel as required.
• Foster/arrange cross-site sharing of information and training.
Required Knowledge, Skills, and Abilities:
• Knowledge of computers and Microsoft Office
• Knowledge of Good Clinical Practices (GCP), Code of Federal Regulations and FDA guidance as it pertains to clinical research and monitoring.
• A proven and successful track record in monitoring and management of investigational sites in large multi-center clinical trials preferred.
• Experience in reviewing clinical trial data assuring accuracy, completeness and adherence to protocols and regulations/guidelines regarding good clinical practices.
• Strong communication skills and proven ability for effective communication verbally, in writing, and through email.
• Great attention to detail.
• Ability to establish goals and agendas.
• Self-motivated, resourceful with strong organizational skills and able to multi-task and work collaboratively and effectively in large, complex, multi-departmental, cross-functional teams.
• Strong clinical project management skills preferred.
• Diplomatic skills, excellent judgment and strong interpersonal skills needed.
• Experience working in an international, multi-cultural setting desired.
• Flexibility and willingness to travel to other field sites in Africa.
Minimum Education/Training Requirements:
• BS/BA in a scientific, life sciences field or equivalent. Advanced degree, nursing degree or a Master’s degree in public health is highly desirable.
Minimum Experience:
• 4 to 6 years of clinical trials experience.
• Experience with HIV and/or vaccine clinical research trials, HIV related laboratory procedures, clinical safety laboratory testing desirable.
Physical Capabilities:
• Frequent standing, sitting, walking, lifting, and travelling.
Required Licenses, Certification or Registration:
• CCRA or CCRP certification highly recommended but not required.
Work Environment: Primarily office but also laboratory, clinic or hospital environment as position is based full-time in Mbeya, Tanzania.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources
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