Clinical Research Associate
7555 Gateway Boulevard Newark, CA 94560
Clinical Research Associate
Clinical Research Associate (CRA) reports to the Manager – Monitoring and Study Support within Clinical Operations and works closely with the Clinical Program Managers (CPMs) / Clinical Study Managers (CSMs) to provide key support in oversight of study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. The CRA works with clinical project team members, vendors, and CRO CRA teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met. The CRA, in partnership with the CPM or designee, will also ensure that Clinical Operations’ leadership team is aware of all monitoring metrics and related site critical issues. This position will reviewrelevant study documents, trip reports, monitoring trends, track monitoring deliverables, and recommend potential solutions to identified issues.
- Support clinical monitoring activities to help ensure the safety and well-being of study participants/patients at clinical site(s);
- Act as primary liaison for assigned study sites to convey project information and ensure site(s) compliance with study protocols, plans and guidelines, Good Clinical Practices (GCPs), and applicable regulations;
- Oversight of the source data verification and monitoring process and/or remote monitoring to help ensure data integrity.
- Monitoring Responsibilities:
- Oversees the conduct of all types of clinical monitoring visits, (e.g. pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects. Conducts these visits if needed;
- Involved in initial review of study documents, (e.g. protocol, CRFs, informed consent forms, IXRS manuals, laboratory manuals, vendor manuals [not all inclusive]);
- Monitors site performance and compliance and provide management with necessary reports, updates and recommendations via interaction with CRO Lead CRA / CRA(s).
- Assists CRO CRAs, sites and data management with data query resolution;
- Supports CRO and CPM or designee in training site personnel on sponsor and regulatory requirements for study conduct; participates in Investigator Meetings.
- Conducts site co-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 study plans, GCPs, and applicable regulations; prepares and/or reviews monitoring visit reports and associated documentation;
- Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, correctness and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current, and is documented appropriately;
- Works with the CRO CRAs to ensure appropriate and timely transmission of clinical data to the data management centers; timely review of data queries, andproactive preparation for interim or final data base lock activities. Works with the CRO CRAs and inhouse TMF representative to ensure health of the TMF during the entire course of the study;
- Works with the CRO CRAs to ensure timely site close out visits including identifying issues to be resolved in timely manner, assure Essential Documents, data and other study related materials are in place and completed and may be involved in preparing site close-out reports;
- Supports and reviews site data quality trends via trip reports and data review including queries and protocol deviations in partnership with CPM or designee;
- Supports preparation and may develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings;
- Develops Clinical Monitoring Plans;
- Supports review of or develops monitoring tools;
- In conjunction with Clinical Development/Operations leadership and vendor, develops and tests EDC, IXRS, data analytics and TMF functionality;
- Facilitates CRO CRA project meetings as necessary;
- Provides a key role in problem solving and issue escalation, regarding monitoring issues, with proposed solutions to the CPM or designee, CRO Lead CRA andDirector of Clinical Operations.
- Assists Clinical Operations in inspection readiness activities
- Perform other duties as required
Required Education and Experience:
- Requires a minimum of a Bachelor’ s Degree, preferably in a scientific, healthcare, or related field.
- Requires a minimum of three (3) years’ experience as a Clinical Trial Associate or about two (2) years of CRA experience. Sponsor experience preferred.
- Must have a valid driver’ s license.
- Willingness and ability to travel 25% of the time with some overnight and weekend travel required.
Preferred Additional Skills (i.e., Computer):
- Highly organized and detail-oriented
- Critical thinking abilities
- Computer literate
- Strong problem-solving abilities.
- Excellent written and verbal communication and time management skills
- Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs
- Scientific/clinical knowledge to be able to understand the nature of the laboratory assays being studied
- Must have excellent people skills and demonstrate the ability to work successfully in a team environment
- Ability to prioritize and to manage multiple tasks as necessary
- Ability to work in a team as well as independently, and to manage multiple priorities with minimal support in a fast pace environment
- High customer orientation awareness and focus