FSP Clinical Research Associate II

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Clinical Research Associate II (CRA Level II) performs and coordinates clinical monitoring and site management activities. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manages required documentation, and works with procedures and guidelines across different sponsors and monitoring environments. 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 and audit readiness. The CRA also develops collaborative relationships with investigational sites. The position involves risk-based site monitoring, review of data and investigational product records, site initiation and closeout, essential document management, issue follow-up, and communication with sites, clients, and project teams. It requires frequent travel to sites, generally 60–80% and potentially more, with the posting also specifying a travel requirement above 75%. Overnight stays may be required. Work may take place in an office, laboratory, clinical, or home-office environment and can involve exposure to biological fluids and infectious organisms, with personal protective equipment required.

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 one year as a clinical research monitor, or other experience providing the knowledge, skills, and abilities to perform the job.
Valid driver’s license where applicable.
Proven clinical monitoring skills.
Understanding of medical or therapeutic-area knowledge and medical terminology.
Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents.
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.
Good oral and written communication skills, including the ability to communicate effectively with medical personnel.
Ability to maintain customer focus through listening skills, attention to detail, and understanding customers’ underlying issues.
Good organizational and time-management skills.
Effective interpersonal skills and attention to detail.
Flexibility and adaptability across a wide range of scenarios.
Ability to work independently or as part of a team, as required.
Good computer skills, including solid knowledge of Microsoft Office and ability to learn appropriate software.
Good English-language and grammar skills.
Good presentation skills.
Ability to work upright and/or stationary for 6–8 hours per day, perform frequent mobility, and complete repetitive hand movements.
Ability to occasionally crouch and stoop and frequently bend and twist the upper body and neck.
Ability to lift or carry light to moderate objects, including luggage and a laptop, with a maximum weight of 15–20 pounds.
Ability to perform under stress, multitask, and work with variable demands and changing conditions.
Regular and consistent attendance.
Ability to comply with specific sponsor, client, or site requirements, including providing vaccination status or other personal information when requested.

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 recommend corrective and preventive actions.
Ensure data accuracy through source document review, source data verification, and case report form 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 using approved business writing standards; escalate deficiencies and issues and follow them through to resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol adherence, resolution of identified issues, and timely data recording.
Conduct monitoring tasks in accordance with 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.
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 in accordance with relevant procedures and protocol, regulatory, and ICH-GCP obligations, making recommendations where warranted.
Perform trial closeout and retrieve 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.
Provide trial status tracking and progress updates to the Clinical Team Manager as required.
Update study systems, such as the Clinical Trial Management System, according to agreed study conventions.
Facilitate communication among investigative sites, the client company, and the project team through written, oral, or electronic contacts.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, promptly.
Assist with preparation of project publications and tools, share ideas with team members, and contribute to project work and process-improvement initiatives as required.
Travel frequently to site locations; travel is generally 60–80%, may be higher for some individuals, and may include extended overnight stays.