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

Thermo Fisher Scientific•Pittsburgh, PA

About The Position

As a Senior Clinical Research Associate I in the FSP model, you will be dedicated to one specific client and act as a representative of that client. You will perform and coordinate clinical monitoring and site management, conducting 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 supporting reliable data. The role also focuses on audit readiness and building collaborative relationships with investigational sites. You will monitor investigator sites using a risk-based approach; review data and investigational product records; document and escalate findings; and follow issues through resolution. You will support site initiation and closeout, maintain essential documents and study systems, communicate with sites and project teams, and contribute to project activities and process improvements. The position requires travel of more than 75% for site monitoring activities. The estimated salary range for this position based in Pennsylvania is $105,000–$112,000. The position may also be eligible for a variable annual bonus based on company, team, and/or individual performance. The U.S. Total Rewards package includes medical, dental, and vision plans; health incentive programs; employee assistance and family support programs; commuter benefits; tuition reimbursement; paid time off and holidays; paid parental leave; insurance and disability coverage; a 401(k) retirement savings plan; and an employee stock purchase plan.

Requirements

Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 3+ years.
Strong critical-thinking and problem-solving skills.
Excellent clinical trial monitoring skills, including remote and on-site monitoring.
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 use of 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.
Use root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective or preventive actions.
Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, during on-site and remote monitoring.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters promptly and in accordance with approved business writing standards.
Escalate observed deficiencies and issues to clinical management and follow them through resolution.
Maintain regular contact with investigative sites between visits to confirm protocol compliance, issue resolution, and timely data recording.
Conduct monitoring tasks in accordance with 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 (CTM) as required.
Keep study systems, including the Clinical Trial Management System (CTMS), updated according to agreed study conventions; perform quality-control checks of CTMS reports where required.
Participate in investigator meetings as necessary.
Identify potential investigators with the client company and assess the acceptability of qualified investigative sites.
Initiate clinical trial sites according to relevant procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations; make recommendations where warranted.
Ensure trial closeout and retrieval of trial materials.
Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations; conduct on-site file reviews as specified by the project.
Assist with project publications and tools and share ideas and suggestions with team members.
Perform additional study tasks assigned by the CTM, such as trip report review, newsletter creation, or leading CRA team calls.
Facilitate communication between investigative sites, the client company, and the project team through written, oral, and electronic contacts.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, promptly.
Contribute to other project work and process-improvement initiatives as required.

Benefits

National medical and dental plans and a national vision plan, including health incentive programs.
Employee assistance and family support programs.
Commuter benefits.
Tuition reimbursement.
At least 120 hours of paid time off (PTO).
10 paid holidays annually.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance.
Short- and long-term disability coverage in accordance with company policy.
Competitive 401(k) U.S. retirement savings plan.
Employee Stock Purchase Plan (ESPP), with eligible colleagues able to purchase company stock at a discount.
Potential eligibility for a variable annual performance bonus.