Description

CRA II - Barcelona or Madrid. Early Phases and experience in Ophthalmology studies.

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to inVentiv Health Clinical SOPs and/or client guidelines

Recruit investigators for participation in clinical trials

Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites

Develop Case Report Forms for clinical trials Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators' Meetings

Prepare and process Serious Adverse Event (SAE) reports

Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries

Resolve queries of CRF data with study site personnel

Review Tables and Listings generated from study data

Assist in writing Clinical Study Reports

Train junior CRAs on monitoring, internal procedures, and query resolution

CRAs ensure patient safety and data integrity as well as regulatory reconciliation to always maintain audit readiness

The CRA supports project teams in the placement, implementation, communication, site management, co-monitoring, recruitment and retention (R&R), issue/deviation identification and resolution, site specific corrective action plan set-up/follow-up, audit preparation and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects

Qualifications

What we're looking for

4-6 years of general pharmaceutical industry or clinical research experience, and 2-3 years of monitoring experience.

Bachelor's Degree or RN

English fluent

Experience in Early Phases and Ophthalmology studies.

Excellent written and verbal communications skills

Ability and willingness to travel

Excellent organizational skills and ability to manage time and work independently



Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.