FSP CRA I or II

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 activities for a specific sponsor. The role includes conducting remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, ensure audit readiness, and develop collaborative relationships with investigational sites. The CRA ensures trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to protect subjects’ rights and well-being and ensure data reliability. The position involves risk-based monitoring, identifying site process failures and appropriate corrective and preventive actions, reviewing clinical data and investigational product records, documenting findings, and escalating and following issues through resolution. The CRA supports site initiation and closeout, maintains essential documents and study-system records, communicates with sites, sponsor staff, and project teams, and contributes to project activities and process improvements. Work is performed in an office, laboratory, clinical, and/or home-office environment and includes frequent travel to sites, generally 60–80%, which may involve 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 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 effective communication with medical personnel.
Customer focus, including listening skills, attention to detail, and ability to perceive underlying customer issues.
Good organizational and time-management skills; effective interpersonal skills and attention to detail.
Ability to remain flexible and adaptable, and 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 and good presentation skills.
Ability to travel frequently to site locations, generally 60–80%, with possible extended overnight stays.
Ability to work with exposure to biological fluids and potential infectious organisms, using required personal protective equipment.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach; identify site process failures and corrective or preventive actions through root cause analysis, critical thinking, and problem-solving.
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 monitoring observations in reports and letters in a timely manner using approved business-writing standards.
Escalate deficiencies and issues to clinical management promptly and follow issues through resolution; maintain contact with sites between visits as needed.
Conduct monitoring activities according to the approved monitoring plan and participate in investigator payments.
Share responsibility with project team members for resolving issues and findings, and investigate and follow up on findings as applicable.
Participate in investigator meetings as necessary and engage directly with sponsor staff and other project personnel.
Work with the client company to assess qualified investigative sites; initiate sites according to relevant procedures and recommend actions where warranted.
Perform trial closeout and retrieval of trial materials.
Ensure essential documents are complete and in place in accordance with ICH-GCP and applicable regulations; conduct on-site file reviews as specified by the project.
Provide trial-status tracking and progress updates to the Clinical Team Manager as required, and update study systems according to agreed study conventions.
Facilitate communication between 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, in a timely manner.
Assist with project publications and tools, share ideas with team members, and contribute to project work and process-improvement initiatives as required.