[Hiring] Senior Clinical Research Associate @ClinChoice

Role Description

We are currently seeking a Senior Clinical Research Associate (Senior CRA) to join our team on a full-time, permanent basis. This is a remote position based in Spain, with Barcelona as the ideal location. Regular travel to clinical trial sites is required.

In this role, you will support 2–3 clinical trials and be responsible for site monitoring activities, including study start-up, conducted both on-site and remotely.

You will have the opportunity to work across a diverse portfolio of projects for clients ranging from small and emerging companies to large pharmaceutical, biotechnology, medical device, and consumer health organizations.

Join our team: you can be part of making a difference in people’s lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

• Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
• Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites.
• May act as Feasibility Associate.
• Train site staff in all study procedures.
• Conduct periodic monitoring visits, including completion of monitoring visit report.
• Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
• Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
• Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
• Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• Act as the main contact person for the site to ensure close follow up.
• Provide general support to the Clinical Research Division on quality control of clinical data.
• Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.
• Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
• Develop training material and give training in collaboration with the Training & Qualification Management Unit.
• May assist with contract negotiation with sites on study budget after appropriate training.
• Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.
• May support the submission process in the project including submission requirements, timelines, informed consent development, etc.
• Guide and supervise Clinical Research Associate I (CRA I) in order to coach and train them on the job.

Qualifications

• University Degree in scientific, medical or paramedical disciplines.
• At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate (CRA) performing on-site monitoring activities.
• Previous experience working for a CRO is required.
• Experience with a broad range of therapeutic areas is desired.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Fluent in English and Spanish - required.
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel.

Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.