The Alaka'ina Foundation Family of Companies (FOCs) is looking for a Clinical Research Coordinator to support our government customer in Camp Lejune, North Carolina.
Responsibilities
- Design, develop, and write research protocols, manage Institutional Review Board and Public Health Review Board submissions and approvals, recruit subjects for studies, and lead the planning/execution of research protocols.
- Support senior research staff in coordinating research study protocols and ensuring protocol compliance (DoD and Federal regulations).
- Assist in literature reviews and protocol development.
- Oversee participant recruitment and consent.
- Perform data entry for research projects in a timely and efficient manner, and maintain clear and accurate records, inventories, and logbooks.
- Assist in complex, non-standard tests and data collection procedures.
- Ensure adherence to legal, professional, and ethical codes with respect to patient confidentiality and privacy (HIPAA/PHI/PII).
Required Degree, Education, and Certification
Bachelor’s degree in speech and hearing sciences, brain and cognitive sciences, audiology, engineering, or related field from an accredited college or university.
Required Skills and Experience
- At least two (2) years of related experience in a research/regulated laboratory.
- Experience with IRB submissions.
- Ability to conduct administrative tasks, adhere to DoD and Federal regulatory guidelines, and carry out research study procedures in a military operational research setting.
- Excellent critical thinking and problem‑solving skills, ability to work cooperatively in a team setting, flexibility in responding to changing demands, timelines, and priorities, and ability to effectively communicate the results of work to clinical, military and academic communities.
- Good communication and analytical skills, ability to meet project deadlines, and experience with technical documentation.
- Knowledge of record‑keeping practices and human subject confidentiality, and medical terminology to include (not limited to) Audiology and Speech Language Pathology.
- Proficiency in reading, writing, speaking and understanding English well enough to effectively communicate with all patients and other health care providers.
- Knowledge of computer operations and proficiency in basic word processing, data entry and automated medical records.
Desired Skills and Experience
Experience managing clinical trials, desired.
Required Citizenship and Clearance
- Must be a U.S. Citizen.
- A Tier I background investigation will be required.
Equal Opportunity Employer
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and need an accommodation during the application process, please request accommodation. We E-Verify all employees.