Associate Clinical Research Manager at PATH

The Associate Clinical Research Manager will be responsible for supporting the planning, oversight and implementation of clinical trials of multiple vaccine and drug trials conducted within the Center for Vaccines, Innovation and Access (CVIA) program and will report to the Associate Director of Clinical Operations under the CVIA Clinical Functional Area. With the guidance of more senior Clinical Research Managers, this position will provide support to all operational aspects related to the planning, implementation, and close-out of clinical trials in addition to other related research activities. This may include contributing to the development of protocols, informed consent documents, case report forms, standard operating procedures, study plans and manuals, RACI charts, and ethical submissions, as well as participating in the selection and monitoring of appropriate clinical sites and CROs and arranging for GCP and protocol-specific training of site staff.

Primary Responsibilities:

• Assist with management of contractual activities of clinical sites and CROs for monitoring, data management and regulatory support.
• Support the selection of clinical trial sites and CROs, training and support of staff.
• Contribute to the planning and conduct of international site visits to help establish trial activities and evaluate operations.
• Assist in development of appropriate study monitoring plans, support site initiation visits and ascertain site readiness for study start.
• Lead maintenance of clinical study timelines and clinical trial risk identification and management.
• Contribute to oversight of protocol implementation by reviewing progress reports from CROs, monitoring reports, and audit reports as needed.
• Identify and participate on the resolution of operational compliance and logistical problems impacting trials quality.
• Assist in development and review of Clinical Protocols, ICFs, CRFs, SOPs and other trial related documents.
• Support the planning and coordination of site audits, including defining, scheduling, assessing and evaluating eventual outcomes, and supporting remedial plans.
• Assist or Lead drafting and submitting of ethical review packages to PATH Institutional Review Boards, including annual renewals, and scientific packages for Scientific Merit Review.
• Implement and maintain project documentation for the lead CRM.
• Support the maintenance, and final archiving of the Trial Master Files following ICH-GCP and PATH internal procedures.
• May assist with or lead coordination of study-specific meetings and maintaining study-related documentation.
• Assist in the procurement, coordination and delivery of clinical trial supplies according to trial protocol specifications.
• Support the coordination and delivery of clinical trial specimens to testing laboratories according to trial protocol specifications.
• Coordinate access to biobank specimens for secondary use, including tracking of ethical approvals, shipments coordination and final accountability.
• Monitor bio-specimen repository in terms of inventories, sample movements and quality assurance system including routine evaluation of staff, facilities and documentation.

Required Experience

• Bachelor’s degree or higher in a related scientific discipline (i.e., a core biological science, nursing, epidemiology, public health, etc.) and at least 2-years of prior experience supporting clinical research studies.
• Experience in international clinical research in low-resource countries
• Familiarity with international regulatory requirements, procedures, and policies
• Basic knowledge of GCP, ICH, and other Guidance documents and policies related to clinical trial operations
• Ability to analyze information, review reports and prioritize actions.
• Excellent computer skills.
• Strong verbal and written communication skills.
• Ability to work well in a team environment, receive directions from others and work independently to achieve delegated tasks with high quality and according to required timelines.
• International and domestic travel 15-20%.
• Open, engaging, collaborative, and transparent work style.
• Global perspective and mindset; ability to work effectively with colleagues from other cultures.