FHI 360 recruits Research Associate II – Durham, NC

Job Summary:

Work closely with senior research staff to develop, implement, manage, and conduct clinical research studies. May be responsible for multiple projects and must work both independently and in a team environment. Maintain systems and processes necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical research projects are conducted on time, within budget and in accordance with Standard Operating Procedures (SOPs), policies and best practices. Prepare clinical study documents such as procedural manuals, project management and monitoring plans, etc. Participate in the clinical study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study plans, and organizing and conducting site trainings. Assist with entire Request For Proposal (RFP) process from development of RFP to vendor selection.

*** This position is pending funding approval.

Accountabilities:

  • Manage (independently or in support of project leadership) day-to-day operations of one or more clinical trials, including trial start-up, conduct and close-out activities.
  • Work with other departments and functional teams within FHI 360 to track tasks and ensure that deliverables, timelines and quality metrics are met;
  • Ensure that projects are conducted in compliance with under US and or non-US regulations and FHI 360 SOPs.
  • Develop training materials and conducts training for study implementation based on company policies and standard operating procedures (SOPs).
  • Provides input with questionnaire development, analysis, study design, and material management.
  • Plan, organize, and manage resources/processes for successful completion of on-time study goals.
  • Develop, implement and manage clinical operational plans, informed consents, clinical trial registration, internal and external reports, project-specific training matrices, study manuals, and other required clinical documents.
  • Conduct in-house/centralized project monitoring activities including essential study document management (eTMF), quality control reviews, clinical data reviews, remote investigational study product and specimen temperature monitoring.
  • Serve as the liaison with internal and external partners to ensure effective collaboration efforts.
  • Oversee planning of internal and external meetings (e.g. team meetings, partner/site calls, DSMB meetings, sponsor meetings)and drafting necessary documents.

Applied Knowledge & Skills:

  • Excellent oral and written communication skills.
  • Organized, proactive, and proficient at multi-tasking with exceptional attention to detail.
  • Effective in presenting information and responding to questions from project teams, external vendors and clients.
  • Can delegate to Clinical Trial Associates or Research Assistants and prioritize assignments.
  • Proficient with current ICH Good Clinical Practice; Information, Privacy and Security; and Protection of Human Subjects standards.
  • Can work under the direction of project leadership and show initiative in problem solving and project planning.

Problem Solving & Impact:

  • Works on problems of diverse scope that require analysis or interpretation of identifiable factors.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Decisions may affect a work unit or area within a department.

Supervision Given/Received:

  • Provides suggestions on business and operational decisions that affect the department.
  • Typically reports to a Manager.
  • Must work cohesively and in collaboration with lead project oversight.

Education:

  • Master’s Degree or its International Equivalent
  • Knowledge/Information Services, Communications, Education, Environment, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.

Experience:

  • Typically requires 5-8 years of clinical research experience and study implementation.
  • Proficiency in Microsoft Office.
  • Articulate, professional and able to communicate in a clear, positive fashion.
  • Must be able to read, write and speak fluent English.
  • Related prior work experience preferred.
  • Clinical monitoring experience, strongly preferred.

Typical Physical Demands:

  • Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.

Technology to be Used:

  • Personal Computer, Microsoft Office (e.g., Word, Excel, PowerPoint, Project, etc.), e-mail, telephone, printer, calculator, copier, and cell phones.

Travel Requirements:

  • Up to 10%

This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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