Avis d’appel à candidature : FHI recrute un(e) Responsable de la recherche clinique aux Etats-Unis.

 

 

 

 

 

 

 

 

Job Summary:

Clinical Research Manager (CRM) I supports the clinical operations teams in the implementation of contraceptive clinical studies and research projects. The CRM I assists in the development, implementation, management, and conduct of clinical research studies, from protocol development and study start-up, to study completion and publications. Primary duties include assisting in managing cross-functional study teams, tracking site activities and progress, coordinating study training, facilitating communications, managing study files, and coordinating study reporting, among other activities. All activities performed are under supervision by senior staff.

Responsibilities:

The CRM I assists in the management of one or more clinical studies, through the following activities, all under appropriate supervision:

  • Assisting in the coordination of cross-functional study teams​;
  • Communicating with clinical sites, sponsors, and vendors;
  • Monitoring key indicators for study quality and performance.

Contributing to protocol development including:

  • ​Drafting operational protocol sections;

  • Ensuring consistency throughout the protocol document;

  • Coordinating reviews and collating comments and edits;
  • Ensuring compliance with regulatory authorities when writing and reviewing;
  • Assisting in the preparation, submission, and tracking of IRB materials;
  • Developing and coordinating team review of training materials and slides, procedural manuals, and other materials; tracking training completion;
  • Facilitating and delivering components of study-specific training.

Providing technical assistance and supporting clinical sites through:

  • Tracking site activation and performance, which may include study accrual, timelines, and close-out;

  • Identifying and communicating potential problems;

  • Conducting site visits, including for site evaluation, initiation, assessment, and close-out;
  • Assisting in the creation and monitoring of study budgets, invoices, and contracts;
  • Forecasting, procuring, and distributing study supplies;
  • Preparing for and participating in audits by study sponsors or other oversight bodies.

Facilitating team meetings/calls including:

  • Writing and/or reviewing meeting minutes;
  • Ensuring key decisions are documented;
  • Tracking action items to resolution.

Maintaining study files including:

  • Setting up and maintaining shared filing systems (e.g., SharePoint, MS Teams);
  • Developing and maintaining tracking tools (e.g., Excel/Word document tracker, project management software tool);
  • Collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF]);
  • Contributing to the eTMF Management Plan;
  • Conducting periodic Quality Control (QC) activities for document management;
  • Drafting, reviewing, providing input on and/or finalizing documents, such as:
  • Study progress reports;
  • Policies and procedures (e.g., standard operating procedures [SOPs] and manuals of operation [MOPs]);
  • Assisting Working Groups and Committees with meeting coordination, reviews, and other operations;
  • Coordinating reviews of and providing input on abstracts, presentations, manuscripts, final study reports;
  • Performing other duties as assigned.

Applied Knowledge & Skills:

  • Basic knowledge of the conduct of clinical trials, related systems, and procedures;

  • Basic understanding of applicable clinical research regulatory requirements, e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and FDA regulations;
  • Basic understanding of budgets and contracts for invoice review;
  • Ability to work independently and in a cross-cultural team and geographically diverse environment;
  • Ability to work with marginalized and historically excluded populations;

  • Ability to prioritize and multitask, proactively follow up, effectively manage time, assess, meet and/or adapt to changing priorities and deadlines effectively, with strong attention to detail;

  • Proficiency in Microsoft Office 365 (i.e., Word, Excel, PowerPoint, Outlook, Teams) and familiarity with webinar platforms, such as Zoom;
  • Articulate, professional, and able to communicate in a clear, positive fashion with clients and staff;
  • Ability to write clearly and succinctly; must be able to synthesize and summarize information

  • Must be able to read, write, and speak fluent English.

Education:

  • Bachelor’s degree or its international equivalent in clinical research, health, behavioral, life or social sciences, or other related fields;
  • Master’s degree preferred.

Experience:

  • Minimum of 2 years of experience in clinical research, or other research or healthcare-related field.

Application process

Closing date : 03 April 2023