FSP CRA I or II

Thermo Fisher Scientific•Dallas, TX

About The Position

As an FSP Clinical Research Associate (Level I or II), you will perform and coordinate clinical monitoring and site management for one specific sponsor. You will conduct remote or 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 SOPs. The role supports the protection of subjects’ rights and well-being, data reliability, audit readiness, and collaborative relationships with investigational sites. The position involves risk-based monitoring, site management, documentation review, issue escalation and resolution, and communication with investigative sites, sponsor staff, and the PPD project team. Work may take place in an office, laboratory, clinical, or home-office environment and requires frequent travel to site locations, generally 60–80%, sometimes with extended overnight stays.

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.
Well-developed 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.
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.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach; apply root cause analysis, critical thinking, and problem-solving to identify process failures and recommend corrective or preventive actions.
Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) 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 promptly using approved business writing standards.
Escalate observed deficiencies and issues to clinical management and follow issues through to resolution.
Maintain contact between monitoring visits as needed to confirm protocol adherence, issue resolution, and timely data recording.
Conduct monitoring tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process.
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 other relevant workers on a daily basis.
Work with the client company to help ensure the acceptability of qualified investigative sites.
Initiate clinical trial sites according to applicable procedures and ensure compliance with the protocol, regulations, 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 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 (CTM) as required.
Update study systems according to agreed study conventions, such as the Clinical Trial Management System.
Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral, or electronic contacts.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, promptly.
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.