FSP CRA I / CRA II - U.S. South Central Region - Multiple Therapeutic Areas

Thermo Fisher Scientific•Dallas, TX

About The Position

The FSP Clinical Research Associate (Level I or II) performs and coordinates clinical monitoring and site management for one specific sponsor. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and help ensure trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and standard operating procedures. The CRA supports subject rights and well-being, data reliability, audit readiness, and collaborative relationships with investigational sites. The role may be assigned at Level I or II, with specific tasks outlined in a task matrix. The position works on a standard Monday–Friday schedule and is performed in an office, laboratory, clinical, or home-office environment. It involves frequent driving to site locations and frequent travel, generally 60–80%, potentially including extended overnight stays. The role may involve exposure to biological fluids and infectious organisms, electrical office equipment, and, rarely, fluctuating or extreme temperatures. Personal protective equipment such as protective eyewear, garments, and gloves is required.

Requirements

Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to one year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.
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 recognition of customers’ underlying issues.
Good organizational and time-management skills.
Effective interpersonal skills and attention to detail.
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.
In some cases, a combination of appropriate education, training, and/or directly related experience may be accepted as equivalent.

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, 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 observed 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 compliance, resolution of issues, and timely data recording.
Conduct monitoring tasks according to 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.
Participate in investigator meetings as necessary.
Engage directly with sponsor staff and complementary workers on a daily basis.
Collaborate with the client company to ensure 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 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 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, on time.
Contribute to the project team by assisting with project publications and tools and sharing ideas and suggestions.
Contribute to other project work and process-improvement initiatives as required.