FHI 360, Durham NC, United States
Closing Date for Applications:
Performs clinical research development activities with senior research staff to develop, implement, manage, and conduct clinical research studies (from approval of concepts through data analysis and manuscript submission) for the Infectious Disease Clinical Research Consortium (IDCRC). Makes detailed evaluations, observations, analyzes data and interprets results using qualitative/quantitative methods and statistics. Investigates, creates, and employs methods and processes project advancement.
- Leads the development, review, and maintenance of all documents required for study implementation (i.e., protocol, informed consents, manual of procedures, data collection forms, and other study-specific standard operating procedures (SOPs) or appropriate documentation).
- Assists with the design and implementation of clinical research studies, including the sampling, recruitment, and statistical analysis.
- Ensures compliance with government regulations when writing and reviewing protocols, consent forms, analysis plans, reports, and manuscripts.
- Provides input with questionnaire development, analysis, study design, and material management.
- Plans, organizes, and manages resources/processes for successful completion of study goals.
- Facilitates and documents team calls, keeping a written record of major decisions.
- Maintains close contact with site teams and Sponsor representative(s) throughout the study.
- Initiates essential study documents collection and communicates frequently with study sites throughout the study to ensure maintenance of required document renewals and for changes in study staff or sites.
- Ensures timely reporting and completion of deliverables as appropriate.
- Develops training materials and conducts training for study implementation based on sponsor policies and SOPs.
- Provides guidance on any protocol related issues.
- Manages and oversees budget for one or more clinical research projects.
- May act as team lead and mentors staff on training, systems, policies, and regulations. Serves as the liaison with internal and external partners to ensure effective collaboration efforts.
- Oversees planning of meetings, site visits, and drafting necessary documents.
Applied Knowledge & Skills:
- Working knowledge of concepts, practices, and procedures for conducting clinical research studies under government regulations.
- Strong understanding of software programs used to collect data and perform data analysis reviews.
- Excellent oral and written communication skills.
- Ability to analyze and interpret data, identify errors, and prepare reports.
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.
- Receives methods and procedures on new studies.
- Provides suggestions on business and operational decisions that affect the department.
- Serves as team lead to team members.
- Typically reports to a Manager/Director.
- Master’s Degree or its International Equivalent, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
- Typically requires 5-8 years of clinical research experience to include protocol development and study implementation.
- Proficiency in Microsoft Office, SharePoint, and other technology required.
- Articulate, professional, and able to communicate in a clear, positive fashion with sponsors, external collaborators and staff.
- Must be able to read, write and speak fluent English.
- Related prior work experience required.