Clinical Research Associate
Summary of Position
The CRA administers, maintains and coordinates the logistical aspects of clinical trials and other human research projects in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). The CRA is a pivotal point of contact & support for the research team. The CRA works with the research team and institute personnel to support and provide guidance on the administration, compliance, and financial related aspects of clinical studies.
- Oversight of protocol operations and
- Coordinates with Principal Investigator and/or administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and and other applicable agency(s) policies and
- Assists in the development of materials and tools required to appropriately train individuals involved in theconduct of the research protocols.
- Assures that all key personnel engaged in the research project have met training requirements in accordance with federal regulations and other applicable agency(s) policies and procedures. Maintains documentation of training.
- Cooperates with compliance and monitoring efforts related to sponsored program administration andreports instances of noncompliance to the appropriate office.
- Coordinates and facilitates monitoring and auditing visits (if applicable).
- Collaborates to respond to any audit findings and implement approved
- May assist in writing of clinical Standard Operating Procedure (SOPs).
- May help monitor clinical research budgets.
Protocol Preparation & Review
- Reviews, comprehends and prepares for implementation of the
- Attends meetings as required or requested by the Principle Investigator.
- Collaborates to prepare IRB and any other regulatory submission documents as required by the protocol.
- Prepares other study materials as
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
- Reviews and develops a familiarity with the protocol, e.g., study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy
- Communicates study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents dates of training and signatures of studypersonnel trained on study specific training
- Collects documents needed to initiate the study and submits where appropriate.
- Develops and implements recruitment and retention strategies in accordance with IRB requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Assists in assessing potential participants for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or
- Coordinates participant tests and
- Collects, monitors, and reviews data as required by the
- Enters data into the protocol’s electronic data management system.
- Maintains study
- Completes study documentation and maintains study files in accordance with sponsor requirementsand study policies and procedures.
- Retains all study records in accordance with sponsor and IRB
- Assists in preparation of any modifications to the protocol in accordance with Federal regulationsand sponsoring agency policies and
- Manages the day-to-day activities of the study including problem solving, communication and protocol management.
- Ability to flex schedule to ensure protocol requirements are met.
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research.
- Reports data accurately, timely and efficiently.
- Assists with scientific compliance reporting requirements in accordance with Federal regulations andUniversity and sponsoring agency policies and
- Assists in the registration of the study at gov and maintains current information on the site.
- Management of personnel (if applicable).
- Effective coordination and
- Regulatory and compliance knowledge (GCP, ICH, HIPAA, IRB, FDA, NIH, DoD, NASA).
- Able to work
- Ability to work effectively across interdisciplinary
- Excellent computer skills (Microsoft Office, Adobe, data management software)
- Ability to learn new data management
- Excellent verbal and written communication
- Effective time
- Critical thinking / problem
Education and Experience
Bachelors degree and 2+ years of clinical research experience.
Masters degree in relevant field preferred.
Email to firstname.lastname@example.org with the subject line “Clinical Research Associate – YourLastName” and include the following:
- Current resume in pdf format. Name your file: “YourLastName_Resume.pdf”.
- Cover letter in pdf format. Name your file: “YourLastName_CoverLetter.pdf”
- Download this Pre-Interview Questionnaire pdf, fill it out and attach it.
**Application is considered incomplete until all items are submitted.**
Location: Florida Institute for Human and Machine Cognition (IHMC), Pensacola, FL
IHMC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, or protected Veteran status.