Clinical Research Associate II - North-East Coast or Central USA

Linical•Stuart, FL

3d•$95,000 - $120,000

About The Position

The Clinical Research Associate II (CRA II) is responsible for the feasibility, initiation, monitoring, and close-out of investigative sites. The role helps protect the safety and well-being of study participants, ensure site compliance with Good Clinical Practice (GCP), applicable regulations, protocols, and study plans, maintain data integrity through source data verification and monitoring, and ensure compliance with Investigational Product (IP) storage, inventory, dispensing, dosing, and disposition requirements. The CRA II works with investigative sites and the clinical study team throughout the study lifecycle, including site selection and qualification, site initiation and personnel training, monitoring and follow-up, regulatory and ethics committee submissions, data review, and site close-out. The role also supports site payments, budgets and contracts, Trial Master File (TMF) documentation, team meetings, and systems User Acceptance Testing. CRAs report to the Senior Manager of Site Management and Monitoring.

Requirements

Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations, and GCP.
Scientific or clinical knowledge sufficient to understand the nature of the drugs being studied.
Excellent written and verbal communication, time management, organizational, and problem-solving skills.
Fluency in the local language, including speaking and writing, and good comprehension of English 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, including during travel and monitoring visits.
Working knowledge of computer systems, applications, and operating systems.
Ability to travel up to 75%.
Valid driver's license, as required.
Life Science degree, nursing background, or a combination of education or equivalent experience, along with successful completion of a recognized CRA training program.
Demonstrable monitoring and site management experience.

Responsibilities

Participate in identifying potential investigative sites, conduct site qualification visits, collect and review regulatory documents, prepare associated reports and documentation, and participate in final site selection.
Conduct site initiation visits, train site personnel on client and regulatory requirements, participate in or conduct site and investigator meetings, and prepare associated reports and documentation.
Conduct site monitoring visits and follow-up to identify significant issues and ensure study conduct follows study plans, GCP, and applicable regulations; prepare monitoring reports and documentation.
Review site files, records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies and initiate corrective action as needed.
Assist with submissions to central and local Independent Ethics Committees and Competent or Regulatory Authorities.
Arrange site payments and facilitate site budgets and contracts as requested.
Ensure training is completed within a reasonable period and remains current and appropriately documented.
Ensure protocol deviations are documented appropriately and action items are followed through to completion.
Manage site monitoring schedules and follow up on issues between visits, maintaining regular communication with sites and the clinical study team.
Maintain contact with site staff regarding patient enrollment and status, IP supply, site requests, and issues.
Ensure essential documents are filed in the Trial Master File according to project guidelines.
Ensure timely transmission of clinical data to data management; review data queries and clarify or obtain data changes as appropriate.
Conduct site close-out visits, including final IP reconciliation and disposition, review of file completeness and accuracy, and retrieval of TMF documents; prepare associated reports and documentation.
Attend team meetings as required.
Participate in systems User Acceptance Testing as required.
Perform other duties as assigned.