Clinical Research Associate
Behavioral Health Market Context
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Qualifications
- •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
- •Bachelors degree and 2+ years of clinical research experience
- •Current resume in pdf format
- •10 more items(s)
Responsibilities
- •nel to support and provide guidance on the administration, compliance, and financial related aspects of clinical studies
- •General Administration
- •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
- •39 more items(s)
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