FSP Sr CRA - Oncology OR Medical Device - Central US

Thermo Fisher Scientific•Indianapolis, IN

About The Position

The Senior Clinical Research Associate (Level I/II) performs and coordinates clinical monitoring and site management activities for clinical trials in either medical devices or oncology. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and apply procedures and guidelines across different sponsors and monitoring environments. As a site processes specialist, the Senior CRA helps ensure trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and supporting reliable data. The position also supports audit readiness and collaborative relationships with investigational sites. The role uses a risk-based monitoring approach, reviews clinical data and investigational product records, documents findings, and follows issues through resolution. It provides study progress updates, supports site identification, initiation, and closeout, maintains essential documents and study systems, and communicates with investigative sites, clients, and project teams. Other duties include supporting audits and inspections, completing administrative tasks, and contributing to project and process-improvement work. Work is performed in an office, laboratory, clinical, and/or home-office environment, with frequent driving to site locations and frequent travel, generally 60–80% and potentially more. Extended overnight stays may be required. The role may involve exposure to electrical office equipment, biological fluids and infectious organisms, and rarely fluctuating or extreme temperatures. Required personal protective equipment includes protective eyewear, garments, and gloves. The employee must comply with applicable sponsor, client, and site requirements, which may include disclosure of vaccination status or other personal information.

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.
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, investigation, root cause analysis, and problem-solving skills.
Ability to manage risk-based monitoring concepts and processes.
Effective oral and written communication skills, including the ability to communicate with medical personnel.
Customer focus demonstrated through listening skills, attention to detail, and ability to perceive underlying customer issues.
Effective interpersonal skills and strong attention to detail.
Effective organizational and time-management skills.
Flexibility and adaptability across a wide range of scenarios.
Ability to work independently or as part of a team.
Proficiency with Microsoft Office and ability to learn appropriate software.
Good English-language and grammar skills.
Good presentation skills.
Ability to travel frequently, generally 60–80% and potentially more, drive frequently to site locations, and undertake extended overnight stays when needed.
Ability to comply with sponsor, client, and site requirements, potentially including disclosure of vaccination status or other personal information.
Ability to use required personal protective equipment and work in environments that may involve exposure to biological fluids and infectious organisms.

Responsibilities

Monitor investigator sites using a risk-based approach and apply root cause analysis, critical thinking, and problem-solving to identify process failures and corrective or preventive actions.
Assess 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 deficiencies and follow issues through resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol compliance, issue resolution, and timely data recording.
Conduct monitoring tasks according to the approved monitoring plan and share responsibility with project team members for resolving issues and findings.
Participate in the investigator payment process and investigate and follow up on findings as applicable.
Provide trial-status tracking and progress updates to the Clinical Team Manager (CTM), update study systems such as the Clinical Trial Management System (CTMS), and perform quality checks of CTMS reports where required.
Participate in investigator meetings as necessary and collaborate with the client company to identify potential qualified investigators and 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, and conduct on-site file reviews as specified by the project.
Assist with project publications and tools, share suggestions with team members, and complete additional study tasks assigned by the CTM.
Facilitate communication among investigative sites, the client company, and the PPD 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, in a timely manner.
Contribute to other project work and process-improvement initiatives as required.