The Clinical Research Associate II (CRA II) is responsible for the feasibility, initiation, monitoring, and close-out of investigative sites. Major responsibilities include ensuring the safety and well-being of study participants at assigned site(s); ensuring site compliance with Good Clinical Practice (GCPs), applicable regulations, the protocol and study plans; ensuring data integrity through source data verification and monitoring process; and ensuring site compliance with all Investigational Product (IP) storage, inventory, dispensing, dosing, and disposition requirements.
CRAs report to the Senior Manager of Site Management and Monitoring.
Duties and Responsibilities- Participates in the identification of potential investigative sites, conducts site qualification visits, collects, and reviews site regulatory documents, and prepares site qualification visit reports and associated documentation; participates in the final selection of investigative sites
- Conducts site initiation visits; trains site personnel on Client and regulatory requirements for study conduct; participates in and/or conducts site meetings and investigator meetings, and prepares site initiation visit reports and associated documentation
- 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 study plans, GCPs, and applicable regulations; prepares monitoring visit reports and associated documentation
- Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required
- Assists in submissions to the Independent Ethics Committees (central and local) and to Competent / Regulatory Authorities
- Arranges site payments and facilitates site budgets and contracts as requested
- Ensures training is performed within a reasonable period and is current and appropriately documented Ensure protocol deviations are appropriately documented, and action items are followed through to completion
- Manages site monitoring visit schedule, and the follow-up of issues between visits, along with ongoing regular communication with the sites and the clinical study team
- Maintains close contact with the site staff, to be aware of patient enrolment, enrolled patients' status, IP supply and any further site requests or issues
- Ensures essential documents are filed in the Trial Master File (TMF) according to the project guidelines
- Ensures appropriate and timely transmission of clinical data to data management; reviews data queries, and clarifies and/or obtains changes to data as appropriate
- Conducts site close-out visits to include final IP reconciliation and disposition, review of completeness and accuracy of files, and retrieval of documents for the TMF; prepares site close-out visit reports and associated documentation
- Attend team meetings as required
- Participates in systems User Acceptance Testing as required
- Other duties as assigned
Required Skills and Abilities- Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs, and the scientific/clinical knowledge to be able to understand the nature of drugs being studied
- Excellent written and verbal communication skills, and time management, organizational and problem-solving skills
- Fluent in local language (speaking, writing) and good comprehension of English language where English is not the local language
- Excellent people skills and ability to work successfully in a matrixed team environment
- Dedication to quality in all work tasks and deliverables
- Ability to prioritize and manage multiple tasks as necessary, including during travel and monitoring visits
- Working knowledge of computer systems, applications, and operating systems
- Ability to travel up to 75%
- Possess a valid driver's license, as required
Education and Experience- Life Science degree, nursing background and/or combination of education / or equivalent experience combined with successful completion of a recognized CRA training program
- Demonstrable monitoring and site management experience
Physical requirements- Can tolerate prolonged periods of sitting at a desk and working on a computer. Can tolerate travel by car, air, or train as needed to support the job
$95,000-$135,000 base salary, plus PTO and comprehensive benefits.
Are you passionate about helping patients & ready to make an impact? Apply now!
