Clinical Research Associate II

Premier Research International; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Premier Research International is seeking a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team in the United States. You will monitor sponsor sites, ensure data integrity and patient safety according to ICH GCP/ISO14155 guidelines, and manage site visits across remote or on-site modes.

The role requires an undergraduate degree in clinical/science/health fields and 2+ years of CRA experience, with CRA training completed.

Qualifications

• Undergraduate degree or international equivalent in clinical, science, or health-related field; licensed health-care professional or equivalent work experience required
• 2+ years' experience in clinical trials and proven CRA experience; CRA training completed

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per monitoring plan timelines
• Maintains TMF/eTMF and site documents per ICH GCP/ISO14155 guidelines
• Monitors data integrity and patient safety across sites (remote, onsite or other approved mode)
• Plans day-to-day monitoring activities and coordinates site visits (qualification, initiation, interim and close-out)
• Manages query resolution with sites and data management
• Maintains contact with study teams and management and ensures timely communication and documentation

Skills

Read, write and speak

Education

Undergraduate degree in clinical/science/health field

Job description

Premier Research is looking for a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

Your ideas influence the way we work, and your voice matters here.

As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

ROLE RESPONSIBILITIES:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintains submission of expenses according to travel and expense requirements within company guidelines
• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plans day-to-day activities for monitoring a clinical study and sets priorities per site
• Prepares for and conducts on-site or remote qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
• Monitors with knowledge of quality/scope/timeline and budget parameters
• Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member
• Manages query resolution process with sites and Premier Research Data Management
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization's processes per filing guidelines. Maintains an understanding of the required essential documents according to ICH/GCP Appendix C. Reviews site documents and verifies they are accurate, complete, current, and include required updates
• Assists project team with assessing project feasibility and recruitment, as applicable
• Maintains project tracking system of subjects and site information, as applicable
• Participates in Investigators' Meeting as designated by the Project Manager
• Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts
• Attends meetings as required
• Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
• Completes timely entry of hours worked and project codes per time entry guidelines
• Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
• Acquire basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge
• Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
• Maintains proper, timely communication with study teams and management, as needed
• Completes all required internal training (general and study-specific) on-time
• Identifies confidential information and complies with global and local laws and guidelines
• In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
• In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
• Acts as a resource for other CRAs and shares knowledge base and best practices
• Performs other activities as designated

REQUIREMENTS:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• 2+ years' experience in clinical trials and proven previous success as a CRA; previous clinical research experience required, completion of CRA training program
• Read, write and speak