FSP Experienced Clinical Research Associate (CRA II/Sr. CRA I) – Oncology – Respiratory – Cardiovascular – US West

ThermoFisher Scientific; Bothell (WA); On-site; USD 95,000 - 104,000; Full time

Benefits offered by this job

National medical and dental plans

Vision plan

Employee Stock Purchase Plan (ESPP)

PTO 120 hours annually

10 paid holidays

Parental leave (3 weeks bonding, 8 for

401(k) retirement plan

Job summary

Thermo Fisher Scientific is seeking a Clinical Monitor to oversee monitoring at investigational sites, either remotely or on-site in California. You will conduct visits, ensure protocol and ICH-GCP compliance, manage documentation, and coordinate with the sponsor and project team.

Travel will be extensive, and you will contribute to data integrity and audit readiness. The role requires a life sciences degree or RN certification, strong monitoring skills, and proficiency in SOPs and regulatory

Qualifications

• Bachelor’s degree in a life sciences field or RN certification with related qualification.
• 1–5 years clinical research monitor experience or equivalent depending on level.
• Valid driver’s license where applicable.

Responsibilities

• Monitors investigator sites with a risk-based monitoring approach.
• Performs RCA and corrective actions to ensure site compliance.
• Review SDR, SDV and CRF data for accuracy.
• Assess investigational product through inventory and records.
• Document observations in reports, escalate issues for resolution.
• Maintain regular contact between monitoring visits with sites.
• Participate in investigator meetings and monitoring plan execution.
• Update study systems (CTMS) and share progress with the team.
• Travel requirement >75%.

Skills

Clinical monitoring

Medical terminology

ICH-GCP knowledge

Root-cause analysis

Critical thinking

Risk-based monitoring

Communication skills

Time management

Documentation

Teamwork

Attention to detail

Microsoft Office

Education

Bachelor’s degree in life sciences

Registered Nursing certification

Tools

CTMS

Microsoft Excel

Electronic data capture (EDC)

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions and Other Job Information:

Major Job

Responsibilities

• 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.
• Assess investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the 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.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team
• Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System (CTMS)).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.
• Travel requirement >75%.

Job Knowledge

Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Job Complexity

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Supervision

Received /

Freedom to act

Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgement within defined procedures and practices to determine appropriate action.

Interactions /

Business

Relationships

Contracts are primarily internal to the company with infrequent external customer/vendor contact on routine matters. Builds productive internal/external working relationships.

Qualifications:

Education and Experience:

Bachelor’s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-5 years as a clinical research monitor, depending on the level).

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 for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• 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 but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Management Role:

No management responsibility.

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment
• Frequent drives to site locations.
• Frequent travel, generally 60-80% but more for some individuals
• May also include extended overnight stays
• Exposure to biological fluids with potential exposure to infectious organisms
• Personal protective equipment required such as protective eyewear, garments and gloves
• Exposure to fluctuating and/or extreme temperatures on rare occasions
• Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site

Percent Billable:

80% – 100%

Compensation and Benefits

The salary range estimated for this position based in California is $95,000.00–$104,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.