Sr CRA (Level I)

Thermo Fisher Scientific

About The Position

The Senior Clinical Research Associate (Level I) performs and coordinates clinical monitoring and site management activities, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. The role manages procedures and guidelines across different sponsors and monitoring environments, such as FSO, FSP, and government programs. As a site processes specialist, the CRA helps ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and supporting reliable data. The role also helps maintain audit readiness and collaborative relationships with investigational sites. Work is performed in an office, laboratory, clinical, and/or home-office environment. The position involves frequent driving to site locations and frequent travel, generally 60–80%, with possible extended overnight stays. The role may involve exposure to electrical office equipment, biological fluids and infectious organisms, and, rarely, fluctuating or extreme temperatures. Personal protective equipment such as protective eyewear, garments, and gloves is required. The position must comply with specific 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.
At least 3 years of completed on-site clinical monitoring experience.
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 skills, 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 using good listening skills, attention to detail, and the ability to perceive 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 independently or as part of a team, as required.
Good computer skills, including proficiency with Microsoft Office and the ability to learn appropriate software.
Good English-language and grammar skills.
Good presentation skills.
Ability to travel frequently, generally 60–80%, including frequent driving to site locations and possible extended overnight stays.
Ability to use required personal protective equipment and comply with specific sponsor, client, and site requirements.

Nice To Haves

Experience in infectious disease (pneumonia), respiratory, ophthalmology, and oncology clinical studies.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach, applying root-cause analysis, critical thinking, and problem-solving to identify 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 issues through resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol compliance, resolution of previously identified issues, and timely data recording.
Conduct monitoring tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process and 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.
Update study systems, including the Clinical Trial Management System (CTMS), according to agreed study conventions, and perform quality-control checks of CTMS-generated reports where required.
Participate in investigator meetings as necessary.
Identify potential investigators with the client company and assess whether investigative sites are qualified and acceptable.
Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol, regulatory requirements, and ICH-GCP obligations; make recommendations where warranted.
Ensure trial closeout and retrieval of trial materials.
Ensure required essential documents are complete and in place in accordance with ICH-GCP and applicable regulations, and 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, and leading CRA team calls.
Facilitate effective written, oral, and electronic communication among investigative sites, the client company, and the PPD 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.