Clinical Research Associate II

Linical Co.,Ltd.; Florida; On-site; USD 95,000 - 120,000; Full time

Job summary

Linical Co.,Ltd. is seeking a Clinical Research Associate II (CRA II) to oversee feasibility, initiation, monitoring, and close-out of investigative sites in the United States, Florida.

The role ensures participant safety, site compliance with GCPs and regulations, and data integrity through source data verification and monitoring processes. CRAs report to the Senior Manager of Site Management and Monitoring.

Qualifications

• Strong knowledge of GCPs and regulations.
• Excellent written and verbal communication skills.
• Fluent in local language with English comprehension.
• Ability to work in a matrixed team environment.
• Travel up to 75%.
• Valid driver’s license.

Responsibilities

• Identify potential sites and prepare site qualification reports.
• Conduct site initiation visits and train site personnel on requirements.
• Perform site monitoring visits and ensure compliance with study plans and GCPs.
• Review source documents and CRFs for accuracy and completeness.
• Assist in regulatory submissions to ethics committees and authorities.
• Coordinate site payments, budgets and contracts.
• Maintain TMF filings and data transmission to data management.
• Attend team meetings and participate in User Acceptance Testing.
• Close-out visits including IP reconciliation and TMF retrieval.

Skills

Clinical trial process

GCP & regulatory knowledge

Data integrity

Study monitoring

Communication skills

Time management

Travel readiness

Driver's license

Education

Life Science degree

Nursing background

CRA training program

Tools

TMF software

Clinical trial data systems

Job description

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–$120,000 base salary, plus PTO and comprehensive benefits.