FSP Sr Clinical Research Associate

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Sr CRA (Level I) 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 applies sponsor-specific procedures and guidelines across monitoring environments. As a site processes specialist, the Sr CRA helps ensure trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs; protects subjects’ rights and well-being; supports reliable data; and maintains audit readiness. The role develops collaborative relationships with investigational sites and performs assigned tasks as outlined in the task matrix. The position represents the department as a prime contact on projects and coordinates with internal and external personnel. It generally works with little day-to-day instruction, using judgment to select methods and resolve a diverse range of issues. There is no management responsibility. Travel is required, with the posting specifying more than 75% in the job responsibilities and generally 60–80% in the working conditions; extended overnight stays may be included.

Requirements

Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent and relevant formal academic or vocational qualification.
Experience comparable to 2 or more years as a clinical research monitor; equivalent combinations of appropriate education, training, and/or directly related experience may be considered in some cases.
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 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 through listening skills, attention to detail, and recognizing customers’ underlying issues.
Effective interpersonal skills and strong attention to detail.
Effective organizational and time-management skills.
Ability to remain flexible and adaptable in 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 comply with specific sponsor, client, and site requirements, which may include disclosure of vaccination status or other personal information.
Ability to work upright and/or stationary for 6–8 hours per day; perform repetitive hand movements; maintain frequent mobility; occasionally crouch or stoop and frequently bend or twist the upper body and neck; and lift or carry objects such as luggage and a laptop weighing up to 15–20 pounds.
Ability to access and use computer software; communicate complex information; listen to and understand spoken information; interact frequently with others; handle variable tasks and changing conditions; perform under stress; and multitask.
Regular and consistent attendance.

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 data 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 and according to approved business writing standards.
Escalate deficiencies and issues to clinical management and follow them through to resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
Conduct monitoring tasks according to 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 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 and perform quality-control checks of CTMS reports when 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 the protocol, regulatory requirements, and ICH-GCP obligations; make recommendations when warranted.
Ensure trial closeout and retrieval of 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.
Contribute to the project team by assisting with project publications and tools and sharing ideas and suggestions.
Perform additional study tasks assigned by the CTM, such as trip report reviews, newsletter creation, or leading CRA team calls.
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, promptly.
Contribute to other project work and process-improvement initiatives as required.
Travel frequently to site locations; travel is stated as greater than 75% in the responsibilities section.