Clinical Research Associate

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, simulation, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovation to improve the lives of millions.

Overview

DLH Corp is currently seeking a Clinical Research Associate position in support of an on-site National Institutes of Health, National Institute of Environmental Health Sciences (NIH/NIEHS) client at the NIH Bethesda, MD campus and remote support to our client at the NIH/NIEHS Durham, NC campus. Broadly, as the Clinical Research Associate, this position will support all aspects of the clinical trial process, including patient recruitment, data collection, and study compliance monitoring, and will be responsible for ensuring the safety and integrity of research participants, serving as the primary on-site contact for the study, and ensuring the trial adheres to regulatory guidelines and ethical standards.

General Responsibilities:

• Implement study activities in compliance with ICH GCP, NIH, and FDA regulations
• Conduct data entry of protocol study forms
• Other general data entry
• Assist the study team in creating, preparing, and reviewing study forms and completing quality control checks in accordance with FDA and NIEHS Environmental Autoimmunity Group (EAG) guidelines
• Collaborate with study coordinators and other team members to assist with patient enrollment activities including recruitment, screening, scheduling, follow-up, and payment
• Assist study coordinators with regulatory submissions to the NIH Institutional Review Board (IRB).
• Request Medical records
• Collaborate with the study team to maintain the regulatory binder
• Collaborate with the study team to prepare for monitoring visits
• Assist the laboratory staff in the assembly of sample mailing kits
• Maintain iPads used for data collection
• Review completed study forms with patients and provide assistance in form completion and other patient interactions
• Support the study team in developing and maintaining study manuals and tracking sheets
• Participate in study meetings and take detailed minute notes
• Edit study forms to be integrated into REDCap
• Coordinate and assist with sample delivery and pick-up as needed
• Serve as the backup for the EAG lab technician tasks as required
• Assistance with responding to participant inquiries
• Support with drafting study-related newsletters and/or other participant outreach communications
• Provide additional support for various study needs as required

Hybrid working schedule - 80% onsite in Bethesda, MD, and 20% telework

Qualifications Required:

• Ability to plan, prioritize, and organize workflow and procedures
• Excellent communication skills and ability to work collaboratively with a team
• Ability to write clearly and concisely for regulatory reporting and submissions
• Work independently with minimal supervision
• Detail-oriented and able to take accurate meeting minutes
• Flexibility to assist with various study tasks as needed
• Experience supporting clinical studies and working with human subjects
• Experience with REDCap data entry
• Proficiency with MS Word, Outlook, and Excel
• Experience with working with Personally Identifiable Information (PII) and keeping participant information confidential

Desired Skills, Experience, Certifications:

• Familiarity with ICH GCP, NIH, and/or FDA regulations for conducting human subjects research
• Experience with patient enrollment and interactions, phone screening, and scheduling
• Proficiency with REDCap for creating and editing study forms
• Knowledge of medical terminology
• Human Subjects Research and Good Clinical Practice Certification

 Minimum Education/Certifications:

• Bachelor’s degree in public health, clinical research, nursing, epidemiology, or other related field
• Two (2) or more years supporting clinical trials or clinical research in an applied setting that fosters the development of the skills described above

Hybrid working schedule - 80% onsite in Bethesda, MD, and 20% telework

Basic Compensation: $55,500 - $66,500 yearly salary

The salary offered within this range will be based on the selected candidates’ skills, experience, education, market data, and internal parity. DLH may offer other rewards, including performance incentives and program-specific awards.  An applicant’s salary history will not be used to determine compensation.

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.