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 conducting remote and on-site visits to assess protocol and regulatory compliance, managing required documentation, and working with procedures and guidelines across different sponsors and monitoring environments. As a site processes specialist, the CRA ensures trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, supporting subject rights and well-being and reliable data. The position also supports audit readiness and collaborative relationships with investigational sites. Travel is frequent, 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 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 root cause investigation, 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, attention to detail, and identifying customers’ underlying issues.
Good organizational and time-management skills, effective interpersonal skills, attention to detail, and flexibility and adaptability.
Ability to work independently or as part of a team.
Good computer skills, including solid knowledge of Microsoft Office and the 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 in environments with exposure to biological fluids and potentially infectious organisms, using required personal protective equipment.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach; apply root cause analysis, critical thinking, and problem-solving to identify 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 remote and on-site monitoring.
Assess investigational products through physical inventory and records review.
Document observations in reports and letters promptly, escalate deficiencies and issues to clinical management, and follow issues through resolution.
Maintain contact with investigative sites between visits as needed to confirm protocol compliance, resolution of identified issues, and timely data recording.
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; investigate and follow up on findings as applicable.
Participate in investigator meetings as needed and identify potential investigators with the client company.
Initiate clinical trial sites according to relevant procedures and make recommendations as 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, and conduct on-site file reviews as specified by the project.
Provide trial status tracking and progress updates to the Clinical Team Manager and update study systems, such as the Clinical Trial Management System, according to agreed conventions.
Facilitate effective 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.
Assist with project publications and tools, share ideas with team members, and contribute to other project work and process-improvement initiatives as required.