FSP CRA I/II Gen Med - Respiratory - HIV - Oncology

Thermo Fisher Scientific•Austin, 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 conducts remote and on-site monitoring visits to assess protocol and regulatory compliance, oversee documentation, maintain audit readiness, and support collaborative relationships with investigational sites. The CRA ensures trials are conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting participants’ rights and well-being and supporting reliable data. The role covers therapeutic areas including respiratory conditions (such as COPD, asthma, and nasal polyps), HIV, and oncology; respiratory and HIV experience are preferred. Work may take place in an office, laboratory, clinical, or home-office environment. The role involves frequent travel to sites, generally 60–80%, and may include 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 knowledge and skills 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.
Customer-focus skills, including listening, attention to detail, and ability to identify customers’ underlying issues.
Good organizational, time-management, and interpersonal skills.
Attention to detail and flexibility and adaptability across a wide range of scenarios.
Ability to work independently or as part of a team.
Solid knowledge of Microsoft Office and ability to learn appropriate software.
Good English-language and grammar skills.
Good presentation skills.

Nice To Haves

Experience in respiratory therapeutic areas, including COPD, asthma, or nasal polyps, and/or HIV; respiratory and HIV experience are preferred.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify process failures and implement 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 activities.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters in a timely manner using approved business writing standards; escalate deficiencies and follow issues through to resolution.
Maintain contact with investigational sites between monitoring visits as needed to confirm protocol compliance, issue resolution, and timely data recording.
Conduct monitoring tasks according to the approved monitoring plan and participate in the investigator payment process.
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 workers.
Work with investigators and the client company to assess qualified investigative sites; initiate clinical trial sites according to relevant procedures and make recommendations where warranted.
Perform trial closeout and retrieval of trial materials.
Ensure required essential documents are complete and in place in accordance with ICH-GCP and applicable regulations, and 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 conventions.
Facilitate effective communication among investigational 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 preparation of project publications and tools, share ideas with team members, and contribute to other project work and process-improvement initiatives as required.