Clinical Research Specialist
KE-Nairobi
Overview:
The Organization - The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific and charitable organization founded in 1996 whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. IAVI will help advance the development of an AIDS vaccine by: 1) adding value to the HIV vaccine field by identifying opportunities and gaps in vaccine discovery and development where IAVI’s capabilities can best be leveraged; 2) partnering to advance quality HIV vaccine candidates to the clinic; and 3) ensuring that investments in HIV prevention and AIDS vaccine R&D remain central to the public policy and international health and development agendas by serving as a voice for the field in partnership with stakeholders and donors.
IAVI is a young, dynamic and mission-driven organization, and the work environment is fast-paced and intellectually stimulating, relying on the good cheer and high level of collaboration amongst its committed staff members.
Responsibilities:
Job Title: Clinical Research Specialist
Location: Nairobi/Africa
Position Summary:
The Clinical Research Specialist performs activities associated with implementation, managing and monitoring clinical research studies, including Phase I-III clinical trials as well as observational and epidemiology studies based in Africa. The Clinical Research Specialist will work closely with the Medical Director and Director, Clinical Laboratory to implement training activities and programs with African clinical partners. The Clinical Research Specialist will coordinate and monitor the implementation of the training program and provide operational and administrative support to ensure program objectives are achieved.
IAVI’s clinical research is conducted by a matrix of teams responsible for individual clinical protocols and for each individual clinical trial site. The Clinical Research Specialist is a member of the IAVI Medical Affairs Department and is supervised by the Director, Clinical Operations Africa with matrix management from the Africa Regional Director.
Key Responsibilities:
· Working closely with the Medical Director and Director, Clinical Laboratory, coordinate the implementation of degree and non-degree training activities with African clinical partners. Monitor progress to ensure program objectives are met.
· As directed, liaise with African clinical partners to identify potential areas and candidates for training.
· Coordinate the development of annual training plans based on needs and requests of African clinical partners. Track training programs being funded or those to be funded.
· Esure budget forecasts for supported training programs are accurate and provide support and input during annual budgeting and forecasting process.
· Provide administrative support to manage the training activities including support to African clinical partners.
· Prepare report and/or, narrative updates on progress of the training programs as requested.
· Assist with and facilitate the evaluation,development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials.
· Perform clinical trial initiation, monitoring and close-out activities while adhering to all applicable regulatory and IAVI Procedural Documents. Complete IAVI required report forms for all site visit activities.
· With oversight from the Director,Clinical Operations Africa and/or lead CPMdevelop study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents as required.
· Complete monitoring visits to review clinical data for accuracy,completeness and discrepancy resolution in accordance with the project plan.
· Assure study site adherence to the protocol, GCP, Procedural Documents and suggest necessary action to bring about compliance in consultation with lead CPM.
· Ensure proper storage, dispensation,and accountability of all investigational product(s) and trial-related material.
· Receive and review weekly enrollment updates during site/study enrollment period; update team.
· Contribute to the Medical Affairs departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensures adherence to regulations/guidelines for GCP. When applicable is a member of the MA SOP task force.
· Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials.
· Conduct GCP training for research staff and other key stakeholders.
· Maintain liaisons with the IAVI team and study coordinators to ensure proper and timely submissions to ERCs, review and assist in preparation of appropriate responses for re-submission if necessary. Ensure IAVI reviews and approves all documents prior to submission and implementation at the site and track all documentation.
· Receive/obtain copies of all ERC submissions and circulate ERC responses to IAVI; circulate RA submissions for review, track REC and RA and update team members.
· Ensure proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) 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.
Other duties as assigned.
Qualifications:
· BS/BA in a scientific, life sciences field, Professional Nurse (RN) or equivalent required. Advanced degree, nursing degree or a master’s degree in public health is desirable.
· Minimum of 3-5 years experience as a CRA. A proven and successful track record in monitoring and management of investigational sites in large multi-center trials.
· Experience in developing, managing and coordinating degree and non-degree training programs is useful.
· Experience with HIV and/or vaccine clinical research trials, HIV related laboratory procedures, clinical safety laboratory testing desirable.
· Strong proficiency in Good Clinical Practices (GCP), ICH guidelines and regulatory procedures with the ability to train site personnel as needed. Proven track record of meeting clinical trials milestones, timelines and working closely with clinical trial sites to ensure objectives are met.
· Demonstrated ability as a resourceful self-starter who takes initiative, is able to adapt to diverse educational and cultural backgrounds, and maintains a high standard of professional conduct as a representative of IAVI.
· Self-motivated with strong organizational skills and able to multi-task and work collaboratively and effectively in large, complex, multi-departmental, cross-functional teams. Experience working within Project Teams desirable.
· Able to take responsibility for completion of tasks with high quality according to established program timelines, identify problems and possible solutions and assess the impact on timelines.
· Strong communication skills and proven ability for effective communication verbally, in writing, and through email.
· Diplomacy skills, excellent judgment, proven ability to assess site performance and contract research organization performance for internal review.
· Excellent computer skills with knowledge of MS Word, Excel, Outlook and email are required. Additional skills with MS project desirable but not necessary.
· Flexibility and willingness to travel to field sites in Africa and overseas as needed.
