Clinical Research Manager

FHI 360, Washington DC, United States

Skill Required:, IT and ICTResearch and Analysis
Preferred Experience: 
3 Years
Closing Date for Applications: 
1st August, 2021


Job Description

Job Summary:
The CRM will focus primarily on managing high-quality, HIV- or COVID- related Phase 1, 2 and 3 clinical trials and is responsible for the overall coordination and management of clinical studies from start up through close out activities. Works with team members to support the technical and operational aspects of the projects, ensuring the successful completion of clinical studies. Works with major functional area leads to identify and evaluate fundamental issues on the project, make good business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations. S/he works with the team to create operational project plans tailored to the particular needs of each assigned study. Ensures that project progress and deliverables meet contractual requirements. Ensures that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), Work Instructions, policies and practices.

Staff within the Science Facilitation Department of FHI 360 serve as the Leadership and Operations Center (LOC) for the NIH-sponsored HPTN and CoVPN. The LOC is responsible for contributing to and supporting the development, implementation and reporting of HPTN and CoVPN clinical trials and for providing coordination, communications, and support to the HPTN and CoVPN leadership. The LOC is also responsible for arranging and supporting meetings and communications, and for providing logistical and administrative support to the HPTN and CoVPN, as needed.

Staff from the LOC work closely with HPTN and CoVPN staff from the statistical and data management support center(s), laboratory support center(s), NIH, pharmaceutical partners, study teams, clinical research sites and their community programs on various aspects of the respective scientific agendas.

Accountabilities:

  • Assists in the preparation of Phase 1, 2 and 3 protocols, informed consents, standard operating procedures, and other appropriate documentation.
  • Coordinates necessary activities required to implement, manage, and close-out clinical trials studies and sites.
  • Assists with development of training materials and assists with conducting training for study implementation based on company policies and SOPs.
  • Assists with the conduct of site assessments.

Applied Knowledge & Skills:

  • Must have a solid understanding of concepts, practices and procedures for conducting clinical research studies.
  • Excellent attention to detail

Problem Solving & Impact:

  • Works on problems of moderate scope that require a review of various factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Decisions generally affect own job or specific functional area.

Supervision Given / Received:

  • Receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Reports to a Manager. Does not have direct supervision responsibilities.

Education:

  • Master's Degree Preferred
  • Bachelor's Degree or its International Equivalent
  • Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.

Experience:

  • Up to 3 years of previous clinical research experience.
  • Proficiency in Microsoft Office, spreadsheet software and other technology required.
  • Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
  • Able to read, write and speak proficient English.
  • Related prior clinical research work experience preferred.

Source:https://fhi.wd1.myworkdayjobs.com/en-US/FHI_360_External_Career_Portal/job/Durham-NC/Clinical-Research-Manager_Requisition-2021201329


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