Työnkuvaus:
Uusimmat työtiedot yritykseltä FTFIN Fortrea Development Ltd Suomen sivuliike tehtävään CRA II, Suomi. If the CRA II, Suomi avooin työpaikka kohteessa Helsinki vastaa pätevyyttäsi, lähetä uusin hakemuksesi tai CV:si suoraan päivitetyn Jobkos-työpaikkaportaalin kautta.
Huomioithan, että työpaikan haku ei ole aina helppoa, sillä ehdokkaiden on täytettävä yrityksen asettamat vaatimukset. Toivomme, että uramahdollisuus yrityksessä FTFIN Fortrea Development Ltd Suomen sivuliike tehtävään CRA II, Suomi vastaa tavoitteitasi.
Overview
We are currently looking for a Clinical Research Associate based in the Helsinki area with at least 2 years of independent monitoring experience and a willingness to work across multiple sponsors. This is a great opportunity to join Fortrea and contribute to high-quality clinical trials, supporting diverse studies while ensuring compliance, data integrity, and patient safety at every stage.
Responsibilities
- Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
- Conduct site monitoring responsibilities for clinical trials according to Fortrea’s SOPs, ICH guidelines and GCP; including Pre‑study, Site Initiation, Process Monitoring, Routine Monitoring, and Close‑out Visits.
- Prepare and implement project plans related to Clinical Monitoring responsibilities.
- Ensure protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines.
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
- Guarantee that the study Investigational Product inventory and accountability are accurate and that study materials are stored securely and per protocol requirements.
- Ensure adherence to global quality control and CRA performance metrics and audit readiness at site level.
- Act in the project role of a Lead CRA as assigned.
- Ensure staff have proper materials and instructions to safely enter subjects/patients into the study.
- Perform eligibility review, screening, and informed consent verification per regulatory requirements.
- Monitor source data and ensure accurate, complete, and compliant data entry.
- Identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
- Manage travel expenses efficiently in accordance with Fortrea travel policy.
- Travel, including air travel, may be required and is an essential function of the job; prepare and submit trip reports.
- Perform eCRF review, 100% source data verification, query generation and resolution as assigned.
- Assist with administration of clinical research projects, recruiting investigators (if applicable), collecting documentation, and site management.
- Maintain trial management tools/eClinical systems.
- Track IP shipments and supplies as needed.
- Track and follow‑up on serious adverse events as assigned.
- Work closely with the study team to align monitoring with critical study timelines and deliverables.
- Prepare and implement study‑specific monitoring plans and site initiation slides as assigned.
- Attend investigators’ meetings, project team meetings, and teleconferences as needed.
- Perform training presentations for site initiation.
- Assist with training of new employees (e.g., co‑monitoring).
- All other duties as needed or assigned.
Qualifications
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and English, written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience
- Minimum of 2 years of Clinical Monitoring experience.
Physical Demands / Work Environment
- Travel Requirement is 60% of the time (traveling to study sites).
EEO & Accommodations
Learn more about our EEO & Accommodations request here.
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Tiedot työpaikasta:
- Yritys: FTFIN Fortrea Development Ltd Suomen sivuliike
- Tehtävä: CRA II, Suomi
- Työskentelypaikka: Helsinki
- Maa: FI
Näin lähetät työhakemuksen:
Kun olet lukenut ja ymmärtänyt kriteerit sekä vähimmäisvaatimukset, jotka on mainittu työpaikkailmoituksessa CRA II, Suomi at the office Helsinki yllä, valmistele välittömästi hakuasiakirjat, kuten työhakemus, CV, kopio tutkintotodistuksesta ja muut liitteet. Lähetä hakemus 'Seuraava sivu' -linkin kautta alta.
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