FSP Senior CRA I - U.S. Northeast Region - Multiple Therapies

Thermo Fisher Scientific•Pittsburgh, MA

8d•$105,000 - $112,000

About The Position

As a Senior Clinical Research Associate I in Thermo Fisher Scientific’s Functional Service Provider (FSP) model, you will be dedicated to one specific client and act as its representative. You will perform and coordinate clinical monitoring and site management, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. You will help ensure trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and ensuring reliable data. The role also supports audit readiness and collaborative relationships with investigational sites. The position involves monitoring investigator sites using a risk-based approach, identifying and resolving site-process issues, ensuring data accuracy, reviewing investigational product inventory and records, documenting observations, escalating deficiencies, and tracking issues through resolution. You will maintain communication with sites, update and quality-check study systems and reports, support investigator payments and meetings, and provide progress updates to the Clinical Team Manager. You will also help identify and initiate qualified sites, ensure trial closeout and retrieval of materials, maintain essential documents and conduct file reviews, contribute to project materials and process improvements, and communicate among sites, the client, and the project team. The role includes responding to audits and inspections and completing administrative tasks such as expense reports and timesheets. Travel of more than 75% may be required for site monitoring activities.

Requirements

Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Comparable to 3 or more years of relevant experience.
Strong critical-thinking and problem-solving skills.
Excellent remote and on-site clinical-trial monitoring skills.
Demonstrated understanding of ICH-GCP guidelines, applicable regulations, and SOPs.
Ability to analyze data and evaluate identifiable factors when working on problems of diverse scope.
Good judgment in selecting methods and techniques to obtain solutions.
Strong communication and collaboration skills, including the ability to interact effectively with investigative sites, clients, and internal teams.
Ability to represent the client while maintaining professional relationships.
Advanced written and oral communication skills.
Strong organizational skills and attention to detail.
Demonstrated experience using computer systems, including CTMS and other trial-management platforms.
Ability to travel more than 75% as required for site-monitoring activities.

Nice To Haves

Oncology experience.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach.
Apply root cause analysis, critical thinking, and problem-solving to identify site-process failures and corrective or preventive actions.
Ensure data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters promptly using approved business writing standards.
Escalate deficiencies and issues to clinical management and follow them through resolution.
Maintain regular contact with investigative sites between monitoring visits to check protocol compliance, issue resolution, and timely data recording.
Conduct monitoring tasks according to the approved monitoring plan.
Participate in the investigator payment process.
Share responsibility with project team members for resolving issues and findings; investigate and follow up on findings as applicable.
Provide trial status tracking and progress updates to the Clinical Team Manager as required.
Update study systems, including the Clinical Trial Management System (CTMS), according to agreed study conventions.
Perform quality-control checks of reports generated from CTMS where required.
Participate in investigator meetings as necessary.
Identify potential investigators in collaboration with the client to assess the acceptability of qualified sites.
Initiate clinical trial sites according to relevant procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations.
Ensure trial closeout and retrieval of trial materials.
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
Conduct on-site file reviews according to project specifications.
Contribute to project publications and tools and share ideas with team members.
Perform additional study tasks assigned by the Clinical Trial Manager, such as trip report review, newsletter creation, or leading CRA team calls.
Facilitate effective written, oral, and electronic communication among investigative sites, the client, and the project team.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.
Contribute to other project work and process-improvement initiatives as required.

Benefits

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 of 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.
Short- and long-term disability in accordance with company policy.
Competitive 401(k) U.S. retirement savings plan.
Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results.