Clinical Trials Assistant II

FHI 360 has several contraceptive research studies in the planning or start up phases and we are actively expanding our teams to implement these projects. Our team consists of more than 30 contraceptive development professionals with expertise in reproductive biology, gynecology, chemistry, epidemiology, and clinical trial and project management. We are currently seeking qualified candidates for the position of Clinical Trials Assistant II. Job Summary: The Clinical Trials Assistant II plays an essential role in supporting clinical research teams throughout the entire clinical trial process, including protocol development, study management, site implementation, study close out and publications. The primary role of the Clinical Trials Assistant II is to assist clinical research teams by developing study specific documents, creating and maintaining filing and tracking systems to coordinate study progress, drafting and issuing meeting minutes, and facilitating communication. All activities performed are under supervision by senior staff. Responsibilities: Supports clinical research teams by performing tasks related to study management from protocol development and study start up, to study completion and publications, such as: Developing and maintaining shared filing systems (e.g., SharePoint, MS Teams); collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF]) Developing and maintaining systems to coordinate and track study activation, study conduct, site performance, and timelines Assisting with the preparation, submission and/or tracking of regulatory materials Assisting with the development of study documents, which may include drafting study- specific training documents, sections of procedural manuals, etc. Reviewing study documents, operational policies, and procedures; coordinating internal and external reviews; and tracking key decisions Drafting study progress reports; distributing data management reports and other communications Communicating directly with one or more research sites. Providing technical assistance to research sites and study staff, including review of materials, site updates, and query resolution, under supervision Coordinating, and potentially reviewing, the translation/back-translation of study materials from research sites Developing and maintaining systems for acquisition, distribution, and tracking of supplies Assisting with study close-out activities, including Quality Control (QC) of the eTMF and identifying issues for review Tracking publications and reviews; coordinating manuscript reviews Provides overall administrative support to the clinical research team, such as: Drafting and issuing meeting minutes, including action items and decisions under supervision; tracks action items to resolution Developing and maintaining email alias lists Scheduling conference and video calls and providing technical management Assisting in the coordination of meetings, conferences, and trainings Utilizes technology effectively to support the clinical research process, and develops proficiency of relevant systems (e.g., study management tools); identifies innovative ideas and best practices. Performs other duties as assigned Assisting in tracking vendor invoices and project supplies

Qualifications:

Associate degree or its international equivalent in clinical research, health, behavioral, life or social sciences or other related field
Bachelor’s degree preferred
Requires 0-2 years of experience in clinical research or other research or healthcare-related fields
Related prior work experience in clinical research preferred
Ability to write clearly and succinctly; must be able to accurately record meeting minutes and document action items and decisions. Has the ability to track action items to resolution
Must have essential interpersonal skills, and be able to communicate in a professional, clear and positive fashion
Ability to work successfully independently and in a cross-cultural team environment
Ability to prioritize and multitask, proactively follow-up on tasks, effectively manage time, assess, meet and/or adapt to changing priorities and deadlines effectively
Familiar with applicable clinical research regulatory requirements

20.2.2013

Arusha - Dar es Salaam - Dodoma - Geita - Iringa - Kagera - Katavi - Kigoma - Kilimanjaro - Lindi - Manyara - Mara - Mbeya - Morogoro - Mtwara - Mwanza - Njombe - Pemba - Pwani - Rukwa - Ruvuma - Shinyanga - Simiyu - Singida - Songwe - Tabora - Tanga - Zanzibar - International

Experience level : 2 to 5 years
Educational level : Bachelor

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Dar es Salaam
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