Senior Clinical Research Associate

hace 5 meses

Barcelona, España ClinChoice A tiempo completo

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a **Clinical Research Associate** in our Clinical Operations department in Spain.

Our Clinical Research Associate will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies. This is a full-time, permanent position based in Barcelona, Spain.

Join our team: you can be part of making a difference in peoples' 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 the 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 in order 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.

**Education, Experience and Skills**:

- University Degree in scientific, medical or paramedical disciplines.
- Proven experience as a CRA, performing on-site monitoring activities.
- Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Fluent in English and local language(s).
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
- Willingness to travel.

**Our Benefits in Spain**:

- Competitive Salary
- Health insurance
- Home office allowance
- Meal vouchers
- 23 days of holiday per year + 2 convenio days and bank holidays
- Excellent work-life balance
- Dedicated Line Manager
- Monthly meetings with the line manager
- Full performance and development process with end-of-year reviews
- Team events and end-of-year party
- Career opportunities within in ClinChoice, locally and globally
- Employee satisfaction survey - your feedback is important for continuous improvement

**_ The Application Process_**

**_ Who will you be working for?_**

**_ About ClinChoice _**

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare

**_ Our Company Ethos_**

Our mission drives our culture: to contribute to a healthier and safer world by acceleratin

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