The Infectious Disease Clinical Research Consortium (IDCRC) is an NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases.

FHI 360 has partnered with Emory University to participate in leadership activities and serve as the Protocol Management Center for IDCRC driven research, leading study development and implementation funded by the Division of Microbiology and Infectious Diseases of the U.S. National Institute of Allergy and Infectious Diseases.

The Senior Clinical Trials Assistant (CTA II) performs clinical research development activities with senior research staff for the IDCRC and assists in development, implementation, and oversight of IDCRC multi-site clinical research studies (from protocol development through study closeout). The CTA II closely observes, evaluates and reports on study progress and site operations through study tracking, data management reports, and monitoring follow up.

The primary role of the CTA 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 are performed under supervision of 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:

• 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
• Reviewing study documents, operational policies, and procedures; coordinating internal and external reviews; and tracking key decisions
• 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
• Assisting with study monitoring activities, including Quality Control (QC) of the eTMF and identifying issues for review
• 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
• Performs other duties as assigned

Requirements:

• Associate degree or its international equivalent in clinical research, health, behavioral, life or social sciences or other related field; Bachelor’s degree preferred
• 0-3 years of experience in research or healthcare-related fields; previous work experience in clinical research is strongly preferred
• Familiarity with applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines) is preferred.
• Ability to write clearly and succinctly, able to synthesize and summarize information; must be able to accurately record meeting minutes and document action items and decisions. Knowledge of medical terminology is preferred.
• Strong interpersonal skills and ability to communicate in a professional, clear and positive fashion
• Ability to work independently and in a cross-cultural team and geographically diverse 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
• Proficiency in Microsoft Office 365 (i.e., Word, Excel, PowerPoint, Outlook, Teams)
• Demonstrated effective organizational skills
• Demonstrated strong attention to detail
• Must be able to read, write and speak fluent English

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit or stand for extended periods of time.
• Ability to lift or move up to 5 lbs.

Technology to be Used:

• Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Travel Requirements:

• Less than 10%

The expected hiring salary range for this role is listed below. FHI 360 pay ranges represent national averages that vary by geographic location. When determining an offer amount, FHI 360 factors in multiple considerations, including but not limited to: relevant years of experience and education possessed by the applicant, internal equity, business sector, and budget.

Base salary is only one component of our offer. FHI 360 contributes 12% of monthly base pay to a money purchase pension plan account. Additionally, all US based staff working full-time, which is calculated at 40 hours/week, receive 18 days of paid vacation per year, 12 sick days per year, and 11 holidays per year. Paid time off is reduced pro rata for employees working less than a full-time schedule.

Hiring Salary Range: $50,000- $60,000

This job posting 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 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

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