Clinical Research Associate II - West Coast USA

Linical•Stuart, FL

4d•$95,000 - $135,000

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 supports participant safety and well-being, site compliance with Good Clinical Practice (GCP), applicable regulations, protocols, and study plans, data integrity through source data verification and monitoring, and compliance with investigational product storage, inventory, dispensing, dosing, and disposition requirements. The CRA II reports to the Senior Manager of Site Management and Monitoring. The position involves identifying and qualifying investigative sites, conducting site initiation, monitoring, and close-out visits, training site personnel, reviewing regulatory documents and study records, addressing deficiencies, and preparing visit reports and related documentation. The CRA II also coordinates site communications and schedules, supports ethics committee and regulatory submissions, assists with site budgets and payments, ensures appropriate documentation and data transmission, and participates in team meetings and systems user acceptance testing as required. Travel of up to 75% may be required.

Requirements

Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations, and GCP, along with scientific or clinical knowledge sufficient to understand the drugs being studied.
Excellent written and verbal communication, time management, organizational, and problem-solving skills.
Fluency in the local language, spoken and written; good comprehension of English where English is not the local language.
Excellent interpersonal 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, together with successful completion of a recognized CRA training program.
Demonstrable monitoring and site management experience.

Responsibilities

Identify potential investigative sites, conduct site qualification visits, collect and review regulatory documents, prepare qualification visit 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 initiation visit reports and documentation.
Conduct site monitoring visits and follow up on issues to ensure clinical study activities comply with study plans, GCP, and applicable regulations; prepare monitoring visit reports and documentation.
Review site files and 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 and action items are completed.
Manage site monitoring visit schedules and follow up on issues between visits, maintaining regular communication with sites and the clinical study team.
Maintain close contact with site staff regarding patient enrollment and status, investigational product 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 investigational product reconciliation and disposition, review of file completeness and accuracy, and retrieval of Trial Master File documents; prepare close-out reports and documentation.
Attend team meetings as required.
Participate in systems User Acceptance Testing as required.
Perform other duties as assigned.