Clinical Research Systems – Bioinformatics Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, configure, and transition REDCap, CTDB, and various clinical research applications.

• Administer sanctioned hosting environments, including backup procedures, access management, and system validation.

• Facilitate the secure management and transmission of genomic and clinical data.

• Create and sustain scripts and data integrations utilizing technologies such as Python, R, and SQL.

• Generate technical documentation and offer user support.

• Assist NIH or FDA-regulated clinical research initiatives.

• Collaborate with Government clinical investigators, regulatory personnel, and program officials in a multidisciplinary team setting.

⛳️ Requirements

• A bachelor's degree in computer science, bioinformatics, information systems, or a related discipline.

• A master's degree is preferred.

• At least 5 years of experience in supporting clinical research information systems or bioinformatics environments.

• Experience in the administration, configuration, and migration of REDCap, CTDB, and other clinical research applications.

• Proficiency in managing approved hosting environments, including backup, access control, and system validation.

• Familiarity with NIH and federal information security standards, such as FISMA and NIST 800-53/800-171, as applicable.

• Capability to support secure handling and transfer of genomic and clinical data.

• Skills in scripting and data integration (e.g., Python, R, SQL).

• Experience in technical documentation and user support.

• Five or more years of direct experience in supporting NIH or FDA-regulated clinical research programs.

• Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 (as applicable), 45 CFR Part 46, and HIPAA.

• Current training in human subjects protections and GCP (e.g., CITI or equivalent).

• Experience in a multidisciplinary team environment working alongside Government clinical investigators, regulatory staff, and program officials.

🏝️ Benefits

• Competitive compensation rate.

• Various benefit options.