Clinical Research Systems / Bioinformatics Specialist

Saratoga Ascend; Oregon; Hybrid; USD 120,000 - 160,000; Full time

Job summary

Saratoga Medical is seeking a Remote Clinical Research Systems / Bioinformatics Specialist to support clinical research information systems and bioinformatics environments. The role emphasizes secure data handling, system validation, and regulatory compliance in NIH/FDA-regulated programs.

You will work with multidisciplinary teams, manage hosting environments, and develop data integration pipelines using Python, R, and SQL. A strong emphasis on documentation and user support is required.

Qualifications

• Bachelor's degree in computer science, bioinformatics, information systems or a related field; master's degree preferred.
• Minimum 5 years of experience supporting clinical research information systems or bioinformatics environments.
• Administration, configuration and migration of REDCap, CTDB and other clinical research applications.
• Management of approved hosting environments, including backup, access control and system validation.
• Knowledge of NIH and federal information security requirements, such as FISMA and NIST 800-53/800-171, as applicable.
• Support for secure handling and transfer of genomic and clinical data.
• Scripting and data integration skills (e.g., Python, R, SQL).
• Technical documentation and user support experience.
• Five or more years of direct experience 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 human subjects protections and GCP training (e.g., CITI or equivalent).
• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials.

Skills

Python

R

SQL

Bioinformatics

Data integration

Documentation

Team collaboration

Education

Bachelor's degree in CS/Bioinformatics

Master's degree preferred

Tools

REDCap

CTDB

Hosting environments

Backup & validation

System validation

NIH/NIST standards knowledge

Job description

Saratoga Medical is hiring a Remote, Clinical Research Systems / Bioinformatics Specialist.

Package includes competitive rate and benefit options.

Education

• Bachelor's degree in computer science, bioinformatics, information systems or a related field; master's degree preferred.

Experience

• Minimum of 5 years of experience supporting clinical research information systems or bioinformatics environments.

Qualifications

• Administration, configuration and migration of REDCap, CTDB and other clinical research applications


• Management of approved hosting environments, including backup, access control and system validation


• Knowledge of NIH and federal information security requirements, such as FISMA and NIST 800-53/800-171, as applicable


• Support for secure handling and transfer of genomic and clinical data


• Scripting and data integration skills (e.g., Python, R, SQL)


• Technical documentation and user support experience


• Five or more years of direct experience 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 human subjects protections and GCP training (e.g., CITI or equivalent)


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

Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.