FSP Sr CRA - Medical Device - East Coast

Thermo Fisher Scientific • Indianapolis, IN

4d • $88,600 - $144,900

About The Position

The Senior Clinical Research Associate (Level I/II) performs and coordinates clinical monitoring and site management activities for clinical trials, with options in medical devices or oncology. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manage trial documentation, and ensure studies follow approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures. It helps protect subjects’ rights and well-being, ensure reliable data and audit readiness, and build collaborative relationships with investigational sites.

The role applies risk-based monitoring, reviews trial data and investigational product records, documents observations, escalates and follows issues through resolution, and supports site initiation and closeout. It also tracks trial progress and study systems, ensures essential documents are complete, communicates with sites, clients, and project teams, responds to audits and inspections, and contributes to project tools and process improvements. Work involves frequent travel to sites, generally 60–80%, and may include extended overnight stays.

Requirements

• Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
• Experience comparable to at least 2 years as a clinical research monitor.
• Valid driver’s license where applicable.
• Effective clinical monitoring skills.
• Demonstrated understanding of medical or therapeutic area knowledge and medical terminology.
• Excellent understanding and demonstrated application of ICH-GCP, applicable regulations, and procedural documents.
• Well-developed critical thinking, including a critical mindset, in-depth investigation for root cause analysis, and problem-solving.
• Ability to manage risk-based monitoring concepts and processes.
• Effective oral and written communication skills, including the ability to communicate with medical personnel.
• Ability to maintain customer focus through listening skills, attention to detail, and perception of customers’ underlying issues.
• Effective interpersonal skills and strong attention to detail.
• Effective organizational and time-management skills.
• Ability to remain flexible and adaptable across a wide range of scenarios.
• Ability to work in a team or independently as required.
• Proficiency with Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.
• Ability to comply with specific sponsor, client, or site requirements, including requests to disclose vaccination status or other personal information.
• Ability to travel frequently to site locations; travel is generally 60–80% and may be higher for some individuals, with possible extended overnight stays.
• Ability to work in environments with potential exposure to biological fluids and infectious organisms, use required personal protective equipment, and tolerate rare exposure to fluctuating or extreme temperatures.

Nice To Haves

• An equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.
• Experience or interest in either medical devices or oncology, as multiple options are available.

Responsibilities

• Monitor investigator sites using a risk-based monitoring approach; apply root cause analysis, critical thinking, and problem-solving to identify process failures and corrective or preventive actions.
• Review source data, source documents, and case report forms as applicable to ensure data accuracy through on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner, escalate deficiencies and issues, and follow issues through resolution.
• Maintain contact with investigative sites between visits as needed to confirm protocol compliance, resolution of issues, and timely data recording.
• Conduct monitoring tasks according to the approved monitoring plan and 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 such as CTMS and perform quality checks of CTMS reports where required.
• Participate in investigator meetings as necessary and identify potential investigators in collaboration with the client company.
• Initiate clinical trial sites according to relevant procedures, ensure compliance with protocol and regulatory and ICH-GCP obligations, and 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 preparation of project publications and tools, share ideas with team members, and perform additional study tasks assigned by the Clinical Team Manager.
• Facilitate effective written, oral, and electronic communication among investigative sites, the client company, 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 and 10 paid holidays annually.
• Paid parental leave, including 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.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level