Job description
Assistant CRA – Madrid or Barcelona (home or office based)
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.
PPD clinical research services are looking for an Assistant CRA to join our growing Clinical Operations Team in Spain. The role could be either home or office based in Madrid, or home based in Barcelona.
The main responsibilities include, but are not limited to:
• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
- Completes and documents study-specific training. Orients and trains on any CRG/study-specific systems
- Provides in-house support during pre-study assessments
- Reviews study data from various sources remotely
- Supports site staff, where applicable
- Supports Essential Document collection, review and updating in systems
- Verifies document collection status and drives action for missing/incomplete/expired documents and open document findings, as directed
Education and Experience:
Bachelor’s Degree in a life science-related field or relevant/equivalent combination of education, training and experience that provides the individual with the required knowledge, skills, and abilities.
Prior clinical research experience (comparable to 1 year) would be preferable, as well as, knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Knowledge, Skills and Abilities:
• Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and PPD clinical research services procedural documents
- Effective oral and written communication skills. Fluency in English and Spanish language is essential
- Excellent interpersonal and customer service skills
- Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven flexibility and adaptability
- Ability to work in a team or independently, as required
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
- Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software.
- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
How to apply: Please submit your CV in English.
#LI-SG1
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