FSP CRA (Level I/II)

Thermo Fisher Scientific; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a detail-oriented Clinical Research Associate to monitor investigator sites and ensure compliance with protocols. This role is crucial for improving health outcomes through effective communication and problem-solving. You'll be part of a dedicated team that values integrity and innovation, working towards life-changing therapies on a global scale. With competitive remuneration and a supportive culture, this position offers a unique opportunity to contribute to meaningful work while advancing your career in clinical research.

Benefits

Competitive Remuneration

Annual Incentive Plan Bonus

Healthcare

Career Development Opportunities

Qualifications

• Strong background in HSA and IRB submissions.
• Ensures compliance with ICH-GCP and applicable regulations.

Responsibilities

• Monitors investigator sites with a risk-based approach.
• Documents observations in reports and letters timely.

Skills

Critical Thinking

Problem-Solving

Root Cause Analysis

Regulatory Compliance

Communication Skills

Education

Bachelor's Degree in Life Sciences

Experience in Clinical Trials

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Brings up observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. Maintains regular contact between monitoring visits with investigative sites to ensure protocol adherence, resolution of issues, and timely data recording. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Shares responsibilities with other project team members on issues and findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings. Assists in identifying potential investigators in collaboration with the client to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.

Keys to Success

Education and Experience:

• Strong background in HSA and IRB submissions, with substantial knowledge in ECOS.
• Ensures that essential documents are complete and compliant with ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports. Ensures study systems are complete, accurate, and up-to-date.
• Facilitates effective communication between investigative sites, the client, and internal teams through various contact methods. Responds to regulatory requirements, audits, and inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets promptly.
• Contributes to project team efforts by assisting in the preparation of publications/tools and sharing ideas for process improvement.
• Supports other project work and initiatives as needed.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides an innovative, forward-thinking organization with outstanding career and development prospects. Our company culture emphasizes integrity, involvement, and innovation!