Sr CRA I/II - FSP - Spain

ThermoFisher Scientific; España; A distancia; EUR 42.000 - 62.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Clinical Research Associate (Level I) to monitor clinical sites in a risk-based approach. You will ensure data integrity through SDR/SDV and CRF reviews, manage site visits on-site or remotely, and maintain compliant trial conduct per ICH-GCP.

Strong communication, problem solving, and collaboration with global teams are essential. This role requires 3+ years as CRA, 2+ years in cell therapy, and willingness to work across multiple locations.

Formación

• Total experience: at least 3 years as a CRA.
• Cell therapy experience: at least 2 years on-site.
• Location: various locations.

Responsabilidades

• Monitor investigator sites using risk-based monitoring and perform RCA to identify process failures and CAPAs.
• Provide trial status updates to the Clinical Team Manager and ensure CTMS data is current.
• Participate in investigator meetings and initiate sites per protocol while ensuring regulatory compliance.
• Verify essential documents per ICH-GCP and conduct on-site file reviews as required.
• Assist in publication tooling and share insights with the project team to improve processes.
• Facilitate communication between sites, client and project team and support audits/inspections.

Conocimientos

Risk-based monitoring

Root cause analysis

SDR/SDV/CRF review

Regulatory compliance

CTMS familiarity

Communication skills

Herramientas

CTMS

Microsoft Office

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You’ll Do:

• Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF 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
• 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, CTMS). Performs QC check of reports generated from CTMS system where required.
• 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. Ensures 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.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• 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 other project work and initiatives for process improvement, as required.

Education and Experience Requirements:

• Total experience: at least 3 years as a CRA
• Cell therapy experience: at least 2 years of on-site, hands-on experience
• Location: various locations

Knowledge, Skills and Abilities:

• Effective clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manages Risk Based Monitoring concepts and processes
• Effective 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 detailand the ability to perceive customers’ underlying issues
• Effective interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• 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: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

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.