Sr Clinical Research Associate (Cra)/Principal Cra - West

2+ years

$104600.00–$157000.00

Remote, USA

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate (CRA) / Principal CRA
Location: Remote, with up to 80% travel required
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Company Overview:

At Thermo Fisher Scientific, we are driven by a single mission: to enable our customers to make the world healthier, cleaner, and safer. Our global clinical research services provide essential support for clinical trials, from study startup through to closeout. With ongoing clinical trials conducted in over 100 countries, our portfolio includes laboratory, digital, and decentralized clinical trial services. By joining our team, you will be a part of a company that strives to improve health outcomes and deliver life-changing therapies worldwide.

Position Overview:

We are seeking experienced Clinical Research Associates (CRA) at multiple levels: Senior CRA (Level I), Senior CRA (Level II), and Principal CRA to join our clinical operations team. These roles are responsible for managing the monitoring and site management processes for clinical trials, ensuring protocol and regulatory compliance, and overseeing required documentation. As part of the team, you will play a key role in supporting clinical trials across commercial and government contracts, applying your clinical monitoring expertise to ensure the quality and integrity of trial data.

Key Responsibilities:

Site Monitoring & Compliance:
Monitor investigator sites using a risk-based approach, applying root cause analysis (RCA) and critical thinking to identify and resolve site process failures, ensuring protocol compliance and reducing risks.
Data Integrity & Reporting:
Review data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and CRF review during remote and on-site monitoring visits. Document findings in a timely and professional manner, following business writing standards.
Investigator & Site Interaction:
Maintain regular communication with investigative sites between visits to ensure protocol adherence, issue resolution, and timely data recording. Participate in investigator meetings as needed.
Regulatory & Trial Documentation:
Ensure essential documents are complete and compliant with ICH-GCP and regulatory standards. Perform trial closeout activities and facilitate the retrieval of trial materials.
Project Management:
Provide regular updates on trial status and progress to the Clinical Team Manager (CTM), and update study systems in accordance with agreed conventions (e.g., Clinical Trial Management System).
Risk-Based Monitoring:
Implement Risk-Based Monitoring (RBM) concepts and processes to ensure trial success and mitigate risks. Address findings promptly and work collaboratively with the project team to resolve issues.
Client & Team Collaboration:
Facilitate effective communication between investigative sites, clients, and internal teams. Maintain a focus on customer satisfaction and resolve issues with attention to detail.
Travel & Monitoring Tasks:
Travel up to 80% to conduct site visits, perform on-site file reviews, and monitor trial progress.

Qualifications:

Education & Experience:

Sr CRA (Level I):
Minimum of 2+ years of clinical research monitoring experience.
Sr CRA (Level II):
Minimum of 3+ years of clinical research monitoring experience.
Principal CRA:
Minimum of 5+ years of clinical research monitoring experience, with extensive expertise in all aspects of clinical monitoring.
Education:
Bachelor’s degree in a life science-related field or equivalent (Registered Nursing certification is also acceptable).
Valid Driver's License:
Required where applicable.

Knowledge & Skills:

Proven expertise in clinical monitoring and site management.
Strong understanding of ICH-GCP, applicable regulations, and procedural documents.
Exceptional critical thinking skills with a focus on root cause analysis and problem-solving.
Ability to manage Risk-Based Monitoring concepts and processes.
Excellent organizational, time management, and communication skills.
Experience with medical/therapeutic area knowledge and medical terminology.
Strong proficiency with Microsoft Office and clinical trial management systems.

Work Environment:

Ability to communicate and work effectively with diverse groups.
Must be able to travel up to 80%, including air, automobile, and train travel.
May be exposed to potentially hazardous elements typically found in healthcare or laboratory environments.
Able to perform duties under pressure while handling multiple projects or activities.

Compensation & Benefits:

The salary range for this position based in California is:

Sr CRA (Level I): $82,800 - $130,000
Sr CRA (Level II): $82,800 - $140,000
Principal CRA: $104,600 - $157,000

This role may also be eligible for a variable annual bonus based on performance.

Benefits Include:

Medical, dental, and vision plans
Paid time off (120+ hours), holidays, and parental leave
401(k) retirement savings plan
Employee Stock Purchase Plan (ESPP)
Employee Assistance Programs (EAP)
Tuition reimbursement, commuter benefits, and more.

For a full list of benefits, please visit: Thermo Fisher Total Rewards

Application Instructions:

Thermo Fisher is hiring for multiple levels of CRA positions, with competitive compensation and a comprehensive benefits package. Apply today to join a team that’s dedicated to improving lives through clinical research.