Project Manager
ICON plc
Google Cloud Platform
Clinical Research Associate II / Senior / Principal – Renal, Transplant, Nephrology
Thermo Fisher Scientific
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Illinois
Visit company websiteSalary
💰 $82,800 - $140,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving to identify and correct site process failures
- Ensure data accuracy through SDR, SDV and CRF review via on-site and remote monitoring activities
- Assess investigational products through physical inventory and records review
- Document observations in reports and letters in a timely manner using approved business writing standards
- Escalate observed deficiencies and issues to clinical management and follow through to resolution
- Maintain regular contact with investigative sites between monitoring visits as needed
- Conduct monitoring tasks in accordance with the approved monitoring plan
- Participate in the investigator payment process and shared issue resolution with project team members
- Investigate and follow-up on findings; participate in investigator meetings as necessary
- Identify potential investigators in collaboration with the client to ensure qualified investigative sites
- Initiate clinical trial sites according to procedures to ensure protocol, regulatory and ICH GCP compliance
- Perform trial close out and retrieval of trial materials; ensure essential documents are complete per ICH-GCP and applicable regulations
- Conduct on-site file reviews per project specifications and provide trial status tracking and progress updates to the Clinical Team Manager (CTM)
- Ensure study systems are updated per agreed study conventions and facilitate effective communication between investigative sites, the client company and the PPD project team
- Respond to company, client and regulatory requirements/audits/inspections and maintain administrative tasks such as expense reports and timesheets
- Contribute to project publications/tools, process improvement initiatives and other project work as required
- Progressive and/or more extensive job duties expected with increasing CRA level
Requirements
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Therapeutic Experience Required: Renal, Transplant and/or Nephrology
- CRA (Level II): comparable to 1+ years as a clinical research monitor
- Sr CRA (Level I): comparable to 2+ years as a clinical research monitor
- Sr CRA (Level II): comparable to 3+ years as a clinical research monitor
- Principal CRA: comparable to 5+ years clinical research monitoring experience
- Valid driver's license where applicable
- In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including root cause analysis (RCA) and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills
- Ability to maintain customer focus, good listening skills and attention to detail
- Good organizational and time management skills
- Effective interpersonal skills and ability to remain flexible and adaptable
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
- Frequent travel, generally 60-80%
