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 for a specific sponsor. The role includes remote and on-site visits to assess protocol and regulatory compliance, manage documentation, support audit readiness, and build collaborative relationships with investigational sites. The CRA ensures trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and supporting reliable data. Therapeutic areas include Respiratory, HIV, and Oncology, with Respiratory and HIV preferred.

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 understanding 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 in a team or independently 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.

Nice To Haves

Therapeutic-area experience in Respiratory (including COPD, asthma, and nasal polyps), HIV, or Oncology; Respiratory and HIV are preferred.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach; apply 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 in a timely manner using 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 compliance, resolution of previously 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.
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.
Work with the client company to ensure the acceptability of qualified investigative sites.
Initiate clinical trial sites according to relevant procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations; 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.
Conduct on-site file reviews according to project specifications.
Provide trial-status tracking and progress updates to the Clinical Team Manager as required.
Keep study systems, such as the Clinical Trial Management System, updated according to agreed study conventions.
Facilitate effective 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, in a timely manner.
Contribute to the project team by helping prepare project publications and tools and sharing ideas and suggestions.
Contribute to other project work and process-improvement initiatives as required.