The Clinical Research Associate (CRA) II is a key participant in the implementation and monitoring of clinical trials. Participates in recruitment/selection of new investigators, investigative sites, and outside vendors.
Under minimal supervision, the CRA II displays clinical trial and vendor management experience in the planning, designing, implementation and execution of clinical trial protocols. Works closely with site(s) and vendors to ensure compliance with overall clinical and protocol objectives. Assists in the planning and implementing activities required to conduct and monitor clinical trials and ensures that Good Clinical Practices (GCP) are followed. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Assists in preparation of presentations of scientific meetings and technical discussions.
ESSENTIAL JOB FUNCTIONS:
- Participates in the identification of potential investigators and clinical sites, conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites
- Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, and guidelines, and tools; participates in the establishment of baseline parameters and in the development of subject tracking systems
- Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports
- Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required; provided within a reasonable timeframe; and is current
- Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate
- Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
- May assist in the development of study tools and guidelines to be utilized by the study site(s)
- Display basic skills in writing informed consent templates, protocol and other documents. Applies knowledge of regulatory requirements/SOPs to working practices.
- Reviews site’s informed consent template for presence of GCP requirements, protocol specific information and for accuracy
- Proficient in the coordination and review of regulatory documents to ensure completeness, accuracy and compliance at the site and in the Trial Master File (TMF)
- Assists with site and vendor issues and corrective action plan resolutions
- Ensures ongoing tracking of IND safety reports for the site(s) and works with team members to support safety with resolution of open queries
- Maintains completion of required corporate training on standards, policies and work instructions by due date
- Partners with team members and cross functional teams
- Demonstrates experience as a CRA on single site and multi-center trials
- Attend client meetings
- Attend scientific/professional meetings and training courses as appropriate
High School Diploma or GED is required.
A minimum of a Bachelor’s Degree or equivalent is required. A degree in a scientific discipline, RN, or healthcare related field is preferred, but not required.
A minimum 3 years of related industry experience with a strong emphasis in Phase I Clinical Operations/Monitoring is required.