Worldwide Clinical Trials este o organizație globală de cercetare clinică pe bază de contract, care sprijină companiile farmaceutice și de biotehnologie pe parcursul întregului ciclu de dezvoltare a medicamentelor. Cu o experiență de peste 30 de ani, compania oferă servicii de monitorizare clinică, gestionare a datelor, recrutare a pacienților și consultanță de reglementare în domenii terapeutice precum oncologia, cardiologia și bolile rare. Abordarea sa combină expertiza vastă în studiile clinice cu sprijin personalizat și soluții adaptate studiilor complexe.
In-House Clinical Research Associate I - Romania Remote
Supports clinical trial site data quality, safety reporting, and regulatory documentation. Works remotely on clinical operations for Worldwide Clinical Trials.
Descriere
- Maintain the quality of data submitted by study sites and support timely data delivery
- Coordinate appropriate reporting and follow-up for safety events managed by site personnel
- Compile complete regulatory and ethics submission packages, including IRB approval, informed consent, and laboratory certification
- Update site documentation as needed for filing in the Trial Master File (TMF)
- Conduct feasibility assessments and identify potential study sites when requested
- Work remotely with clinical operations teams, sponsors, and site personnel
Cerințe
- Demonstrated strength in interpersonal, verbal, and written communication
- Ability to work effectively as part of a remote team
- Strong customer orientation and professional communication with sponsor contacts
- Working knowledge of Microsoft Office, CTMS, and EDC systems
- A four-year college program focused on life sciences is preferred but not mandatory
- A two-year college program or equivalent education and training, plus one year of clinical research or related experience
- Fluency in English and Romanian, plus one of German, French, Italian, Spanish, or Polish
Beneficii
- Equal employment opportunity is provided without regard to race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or any other category protected by applicable law