Clinical Research Associate (Spain, Home-based) - IQVIA Biotech
Location: Barcelona, Spain; Madrid, Spain
At IQVIA Biotech, we offer a unique approach to serving biotech customers. A flexible model, therapeutically-aligned teams and dedicated resources in a transparent partnership. As a Senior Clinical Research Associate, you’ll have the opportunity to work directly with customers in a collaborative environment where you'll be part of a team bringing important treatments to patients.
In this highly specialized and dynamic role, you’ll utilize your extensive therapeutic knowledge to oversee uniquely-focused clinical studies. Working at the core of clinical research, you’ll be exposed to cutting-edge protocols and experience a dedicated partnership with your team like never before.
Join us and help reimagine the future of biotech.
- Full Time
- Level: Senior
- Travel: Yes
What makes a Senior Clinical Research Associate at IQVIA Biotech successful? Check out the top traits we’re looking for and see if you have the right mix.
As you grow your CRA career at IQVIA Biotech, you’ll play an important role in helping our customers drive healthcare forward and impact the lives of patients around the world.
What makes IQVIA Biotech different from my past companies is that I partner directly with smaller pharmaceutical companies and am able to become a true ‘expert’ by being aligned with a smaller amount of projects with a larger site load. IQVIA Biotech promotes a strong culture of communication and mentorship and I’ve thoroughly enjoyed my time since joining last year.Leah, Clinical Research Associate 2
Resources that promote your career growth
Leaders that support flexible work schedules
Roles that require specialty knowledge and training
Protocols aligned to your specific expertise
Dynamic work environments that expose you to new experiences
Programs to help you build your therapeutic-knowledge
Clinical Research Associate (Spain, Home-based) - IQVIA Biotech
IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.
We have a vacancy within our Clinical Monitoring Team for an experienced permanent Clinical Research Associate to join our team in Spain
This is a great opportunity for a CRA to join a progressive and developing CRO. Being an integral part to the clinical monitoring team. Making an impact in Biotech and Med-Tech markets, you’ll have training and development to plan and progress your career in the direction you choose. IQVIA Biotech offers a dynamic and fast paced environment that allows to utilise your current skill set and experience.
- Participates in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
- Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
- Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
- Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.
- Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
- May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
- Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
- Assists with, and attends, Investigator Meetings for assigned studies.
- Attends study-related, company, departmental, and external meetings, as required.
- Ensures all study deliverables are completed per IQVIA Biotech and study timelines
- Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
- Serves as mentor for junior CRAs and those new to the company and/or study.
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
- Experience in monitoring and/or coordinating clinical trials required.
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
- Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
- Able to handle several priorities within multiple, complex trials.
- Able to reason independently and recommend specific solutions in clinical settings.
- Able to work independently, prioritize, and work within a matrix team environment.
- Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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