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 a specific sponsor. The role includes remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure trials are conducted according to approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs. The CRA supports the protection of research subjects, data reliability, audit readiness, and collaborative relationships with investigational sites. The position involves risk-based monitoring, site initiation and closeout, essential document review, investigational product checks, issue escalation and follow-up, study tracking, and communication among sites, the client company, and the project team. Work is performed in an office, laboratory, clinical, and/or home-office environment, with frequent driving and travel to sites, generally 60–80%, and possible extended overnight stays.

Requirements

Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
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 and 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 across a wide range of scenarios.
Ability to work independently or as part of a team.
Good computer skills, including solid knowledge of Microsoft Office and ability to learn relevant software.
Good English language and grammar skills.
Good presentation skills.
An equivalent combination of appropriate education, training, and/or directly related experience may be considered.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach, including root cause analysis and corrective or preventive actions to address site-process failures and reduce risks.
Review source data, source documents, and case report forms as applicable to ensure data accuracy through on-site and remote monitoring.
Assess investigational product through physical inventory and records review.
Document monitoring observations in reports and letters promptly and in accordance with approved business writing standards.
Escalate site deficiencies and issues to clinical management and follow issues through resolution.
Maintain contact with investigational sites between monitoring visits as needed to confirm protocol compliance, resolution of 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.
Participate in investigator meetings as necessary.
Engage directly with sponsor staff and complementary workers on a daily basis.
Work with investigators and the client company to assess qualified investigative sites; initiate sites according to relevant procedures and make recommendations where warranted.
Perform 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.
Provide trial-status tracking and progress reports to the Clinical Team Manager as required, and update study systems according to agreed conventions.
Facilitate communication among investigative sites, the client company, and the 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.
Assist with project publications and tools, share suggestions with team members, and contribute to other project work and process-improvement initiatives as required.