Clinical Research Coordinator

Clinical Research Coordinator

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

Description Of Responsibilities:

• Serves 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 (1) to several simultaneous research projects for the PI/Director, ensuring no lapse in study progression while applying practical, hands-on knowledge of GCP to all coordination efforts.
• 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.

Required Degree/Education/Certification:

• Requires a bachelor's degree in a biological science related discipline.

Required Skills And Experience:

• Must provide proof of immunization, or immunity from or screening for the following diseases according to DHA guidelines equivalent to that provided to active work Armed Forces: Hepatitis B, Measles, Mumps, and Rubella, Varicella, Tetanus, Diphtheria, and Pertussis, Tuberculosis (TB), Human Immunodeficiency Virus (Contract employee who has direct patient care) and influenza for all personnel.
• Personnel must successfully complete and maintain current Collaborative Institutional Training Initiative (CITI) certifications, and must demonstrate the practical application of GCP training throughout all research operations.
• Must be willing to sign a Non-Disclosure Agreement (NDA).

Required Citizenship And Clearance:

• Must be a U.S. Citizen.
• Must be able to obtain a CAC card.

Bering-Alaka`ina Holdings, LLC is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.

As a part of BSNC, Bering-Alakaina Holdings gives hiring, promotion, training, and retention preference to BSNC shareholders, descendants and shareholder spouses who meet the minimum qualifications for the job. Qualified job candidates will generally be considered in the following order: BSNC shareholders, descendants, shareholder spouses, current employees, and outside candidates. The BSNC Shareholder Development department tracks and monitors the implementation of the Shareholder Hire Preference across its operations.

Bering-Alaka`ina Holdings (BAH) is comprised of industry-recognized government service firms designated as Alaska Native Corporation (ACN)-owned and 8(a) certified businesses. BAH includes Ke`aki Technologies, LLC; Laulima Government Solutions, LLC; Kūpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kīkaha Solutions, LLC; and Pololei Solutions, LLC.