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 personnel.
- 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 procedures.
- Assists in the development of materials and tools required to appropriately train individuals involved in the conduct 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 and reports 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 recommendations.
- 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 protocol.
- Attends meetings as required or requested by the Principal Investigator.
- Collaborates to prepare IRB and any other regulatory submission documents as required by the protocol.
- Prepares other study materials as required.
- 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 protections.
- 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 study personnel trained on study specific training log.
- 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 exclusion.
- Coordinates participant tests and procedures.
- Collects, monitors, and reviews data as required by the protocol.
- Enters data into the protocol’s electronic data management system.
- Maintains study timelines.
- Completes study documentation and maintains study files in accordance with sponsor requirements and study policies and procedures.
- Retains all study records in accordance with sponsor and IRB requirements.
- Assists in preparation of any modifications to the protocol in accordance with Federal regulations and sponsoring agency policies and procedures.
- 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 and University and sponsoring agency policies and procedures.
- Assists in the registration of the study at ClinicalTrials.gov and maintains current information on the site.
- Management of personnel (if applicable).
- Effective coordination and dissemination.
- Regulatory and compliance knowledge (GCP, ICH, HIPAA, IRB, FDA, NIH, DoD, NASA).
- Able to work independently.
- Ability to work effectively across interdisciplinary teams.
- Excellent computer skills (Microsoft Office, Adobe, data management software).
- Ability to learn new data management software.
- Excellent verbal and written communication skills.
- Excellent organization.
- Effective time management.
- Critical thinking / problem solving.
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.