Senior Clinical Research Associate

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Senior Clinical Research Associate to join our Clinical Data Sciences team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

The position can be offered as home based, office based (Madrid) or a hybrid mix.

What you’ll be doing:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plans day to day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
• Monitors with knowledge of quality/scope/timeline and budget parameters
• Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.

What we are searching for:

• Undergraduate degree or local equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse)
• Previous clinical monitoring experience as a CRA
• Fluency in English and local language
• Previous experience in clinical trials
• Excellent team player, collaborative and able to enable an effective team
• Ability to multitask and work effectively in a fast-paced environment with changing priorities
• Strong verbal and written communication skills
• Excellent organizational and time-management skills, able to meet deadlines
• Valid driver’s license, passport as required

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Fecha de publicación: 17/09/2022