CRA II/Sr CRA - US Southeast Region - Multiple Therapeutic Areas Available

Thermo Fisher Scientific•Miami Beach, FL

About The Position

The Clinical Research Associate (Level II) performs and coordinates clinical monitoring and site management activities. The role involves remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and apply procedures and guidelines across different sponsor and monitoring environments. As a site processes specialist, the CRA helps ensure that trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, while protecting participants’ rights and well-being and supporting reliable data. The role also supports audit readiness and collaborative relationships with investigational sites. The CRA monitors investigator sites using a risk-based approach; reviews trial data and investigational product records; documents and escalates issues; and follows findings through resolution. The role supports site identification, initiation, monitoring, and closeout, maintains essential documents and study systems, provides status updates to the Clinical Team Manager, and facilitates communication among sites, clients, and the project team. The position also involves administrative duties, participation in investigator meetings, and contributions to project tools and process-improvement initiatives. Work is performed in an office, laboratory, clinical, and/or home-office environment. The role involves frequent driving to sites and frequent travel, generally 60–80%, with possible extended overnight stays. There may be exposure to biological fluids and infectious organisms, electrical office equipment, and, rarely, fluctuating or extreme temperatures. Personal protective equipment may be required.

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 role, 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 root cause investigation, 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, attention to detail, and recognizing customers’ underlying issues.
Good organizational and time-management skills.
Effective interpersonal skills and attention to detail.
Flexibility and adaptability 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.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify process failures and 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.
Assess investigational products through physical inventory and records review.
Document observations in reports and letters promptly and according to approved business-writing standards.
Escalate deficiencies and issues to clinical management and follow issues through resolution.
Maintain contact with investigational sites between monitoring visits when 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 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.
Identify potential investigators with the client company and assess the acceptability of qualified investigative sites.
Initiate clinical trial sites according to applicable procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations; 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.
Conduct on-site file reviews according to project specifications.
Provide trial-status tracking and progress reports to the Clinical Team Manager as required.
Keep study systems, such as the Clinical Trial Management System, updated according to agreed study conventions.
Facilitate written, oral, and electronic communication among investigative sites, the client company, and the PPD project team.
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 project publications and tools, share ideas with team members, and assist with other project work and process-improvement initiatives as required.