Clinical Research Coordinator

About the Role

Bering-Alaka`ina Holdings, LLC is seeking a Clinical Research Coordinator to provide support for our government customer in San Antonio, TX.

Responsibilities

• Serve as the primary coordinator for the execution of human research studies, ensuring all simultaneous projects progress according to established timelines and experimental designs.
• Coordinate one to several simultaneous research projects for the PI/Director, ensuring no lapse in study progression while applying practical, hands-on knowledge of Good Clinical Practice (GCP).
• Confer with investigators on experimental design and establish standardized study participant contact procedures.
• Provide professional instruction to research staff on various laboratory techniques and clinical contact protocols.
• Develop and maintain comprehensive research study schedules, coordinating all activities between participants, laboratory staff, and the PI.
• Assist with human research study enrollment, ensuring all recruitment activities align with approved protocols.
• Maintain precise study records based on participant observations and study schedules; provide detailed follow-up documentation to the PI.
• Execute daily activities related to the conduct of the study, ensuring participant safety, protocol adherence, and strict compliance with International Council for Harmonisation (ICH) guidelines for human subject protection.
• Organize complex research information and manage the lifecycle of data collection for each assigned project.
• Prepare and deliver required periodic reports and other specialized research documentation to the PI.
• Prepare professional correspondence, build study files, and develop presentation graphics to support research briefings and publication submissions.
• Apply expert knowledge of the Code of Federal Regulations and ICH guidelines to document all regulatory research and administrative actions to ensure continuous study compliance with IRB and federal standards.
• Navigate and execute FDA regulatory processes, applying proven FDA regulatory experience to prepare necessary documentation, submissions, and reports for regulated clinical trials.
• Monitor research study budgets, tracking expenditures against project milestones to prevent overruns.
• Research equipment and supply catalogs; recommend purchase requests in strict accordance with IRB protocols and mission needs.
• Utilize government-furnished software for accounts tracking, publication submissions, purchase orders, and the preparation of forms for incoming/outgoing funds.
• Other duties as assigned by Supervisor.

Requirements

• Bachelor’s degree in a biological science-related discipline.
• Proof of immunization or immunity from or screening for the following diseases according to DHA guidelines: Hepatitis B, Measles, Mumps, Rubella, Varicella, Tetanus, Diphtheria, Pertussis, Tuberculosis (TB), Human Immunodeficiency Virus (for contract employees with direct patient care), and influenza.
• Current Collaborative Institutional Training Initiative (CITI) certifications and demonstrated practical application of GCP training.
• Willingness to sign a Non-Disclosure Agreement (NDA).
• U.S. Citizenship.
• Ability to obtain a Common Access Card (CAC).

Benefits

• Competitive salary.
• 401K plan with company match.
• Medical, dental, disability, and life insurance coverage.
• Tuition reimbursement.
• Paid time off and 11 paid holidays.

Bering-Alaka`ina Holdings gives hiring preference to BSNC shareholders, descendants, and shareholder spouses who meet the minimum qualifications for the job.