Clinical Research Specialist - Leading Protocol Development Exp. Req. (Job 1416)

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools – including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and simulation, and more. DLH is dedicated to the idea that “Your Mission is Our Passion” and brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovation to improve the lives of millions.

Overview 

DLH is seeking a Clinical Trials Specialist to join the Network Coordinating Center (NCC) of the ACTG (Advancing Clinical Therapeutics Globally for HIV and Other Infections) network, one of the world's largest and longest-running clinical trials networks focused on HIV and its comorbidities. This clinical trials network conducts dozens of protocols at sites in the US and abroad and is led by some of the world’s leading experts in infectious disease and HIV/AIDS. The Clinical Trials Specialist will be responsible for managing protocol teams as they design, implement, and report results from clinical trials. 

Responsibilities 

• Leads protocol development, study start-up, and study conduct activities 
• Leads development of the protocol document, including incorporating input from subject matter experts and investigators, and developing the informed consent form(s) 
• Develops and manages study-specific ancillary documents (e.g., manuals of procedure, site training materials)
• Manages and communicates the status of study progress and activities 
• Drives the resolution of issues encountered with sites during all phases of the study 
• Partners with cross-functional teams (e.g., clinical data management, statisticians, laboratory) during protocol development and implementation 
• Develops and implements processes to mitigate impediments to protocol development and implementation 
• Assesses current and new processes, identifies and implements solutions to improve process efficiency within and across related functional areas 
• Provides coaching and knowledge transfer to team members
• This is a remote role – attendance at an annual network meeting in the DC area is required 

Qualifications 

• Master’s degree in public health, social sciences, or related discipline strongly preferred with at least two years of experience in the design, development, and conduct of Phase I-III clinical trials 
• Bachelor's degree may be accepted with at least five years of experience in the design, development, and conduct of Phase I-III clinical trials
• Experience leading protocol development, including writing clinical research protocols and ancillary documents is required
• Experience with HIV, hepatitis, and/or tuberculosis trials is preferred
• Excellent verbal communication and organization skills; ability to follow detailed work instructions; strong problem-solving and decision-making skills; ability to handle multiple tasks simultaneously and work collaboratively 

Basic Compensation: $80,000 - $90,000 yearly salary

The salary range listed reflects what we reasonably expect to pay for this role at the time of posting. The final offer may vary based on skills, experience, geographic location, market conditions, and internal equity. Additional compensation may include performance incentives and program-specific awards. We do not use salary history to determine compensation, in line with applicable law.

Benefits

DLH Corp offers our employees an excellent benefits package, including Personal Time Off (PTO), medical, dental, vision, supplemental life with AD&D, short and long-term disability, flexible spending accounts, parental leave, legal services, and more. We want our employees to save for their future; therefore, we offer a 401(k) Retirement Plan, which includes a matching component. DLH is dedicated to your career development, providing training to help drive success, with access to our best-in-class e-learning suite for formal and informal learning, professional and technical certification preparation, and education assistance at accredited institutions.

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