CRA (Level II) - FSP

ThermoFisher Scientific; United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to oversee remote or on-site visits, ensure protocol compliance, and manage essential documentation across sponsors and monitoring environments. You will coordinate with study sites and maintain audit readiness, supporting data integrity and patient safety.

As a field-based role with 60-80% travel, you will conduct site qualification, initiation, and ongoing monitoring per ICH-GCP, and work with cross-functional teams

Qualificações

• Bachelor Degree or equivalent (Science or Health Care related).
• 1 year of clinical research monitoring experience or completion of PPD Drug Development Fellowship.

Responsabilidades

• Monitors sites and ensures data accuracy through SDR/SDV review.
• Conducts site qualification, initiation, monitoring and close-out visits.
• Ensures regulatory compliance with ICH-GCP and SOPs; maintains essential documents.

Conhecimentos

Clinical monitoring

GCP/ICH knowledge

Communication skills

Time management

Attention to detail

Critical thinking

Teamwork

Formação académica

Bachelor Degree

Science/Health care related

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

Job Description As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What You'll Do

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary. Identifies potential
• investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.
• Conduct site qualification, site initiation, continuous monitoring and close out visits as per Client process, applicable legislations, ICH/GCP.
• Be the frontline liaison between Client and sites to ensure successful collaboration, meeting client expectations on milestone and deliveries.
• Implementing site management activities with a risk-based mind set and approach.
• Manage assigned study sites and networks
• Conducting phase I-IV protocols according to the Site Monitoring Plan.
• Ensure timely delivery, of high quality, robust and reliable data of the monitored sites

Education and Experience Requirements

• Excellent knowledge of drug development process specifically clinical trials/research/site management.
• Solid understanding of international standards (GCP/ICH, FDA, EMEA).
• Strong communicator and presenter (oral and written), ability to communicate to Senior Leaders/Stakeholders internally and externally.
• Bachelor Degree or equivalent (preferably Science or Health Care related).
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

Knowledge, Skills and Abilities

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexibile and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Working Conditions and Environment

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.