Experienced Clinical Study Coordinator / Clinical Research Associate (CRA) in the Clinical Services department
MAIN DUTIES & RESPONSIBILITIES
Write and collate the main documents for clinical trials, including:
Clinical Protocol and Informed Consent Form (ICF),
Case Report Form (CRF),
Clinical Study Report (CSR), and
Sponsor Trial Master File (TMF).
CRF online revision, data query resolution management with clinics.
Data entry process.
Project management with Sponsors and clinics assistance.
Archive electronic and paper documents.
Actively support senior members of the Clinical Services team in, among others, defining procedures and document templates.
REQUIRED PROFILE & QUALIFICATIONS
Bachelor/Master Degree in life sciences studies.
Minimum 3 years’ experience as a Medical Writer or Clinical Research Associate (CRA).
It will also be greatly valued experience in regulatory medical writing of essential documents (incl. Protocols, subject Informed Consent Forms, or Clinical Study Reports) for EMA clinical trials (within Pharma Industry or Clinical CRO).
Experience with Bioequivalence studies will be also valued.
Excellent working knowledge of ICH GCP guidelines.
Fluent spoken English and solid English grammar and editorial skills.
Proficiency in MS-Office, Adobe Acrobat and Outlook.
OTHER REQUIRED SKILLS
Good organizational skills and high attention to detail, with the ability to handle multiple tasks effectively and efficiently.
Ability to work both as part of a team and independently, as required.
High level of motivation and an enthusiastic personality.
WHAT IS OFFERED
Opportunity to work and contribute to the success of an expanding CRO and a growing team.
Highly reputed and experienced clinical team with career growth opportunities.
International and multicultural environment in company based in Barcelona.
Diligent, professional organization, with a human touch.