Description

INHOUSE CRA. BARCELONA OR MADRID. SPONSOR DEDICATED

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 Summary

An In-house Clinical Research Associate will work closely with the Clinical Research Associates (CRAs) by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator/site communications and clinical monitoring tracking at a site, regional and global level. In addition, the In-house CRA will liaise with the study team to ensure study information is proper communication to the site and CRAs.
Performs remote site management and monitoring activities on assigned project(s) in accordance with FDA/EMA and/or local regulations and guidelines, ICH GCPs. Reviews study data from various sources remotely. Contacts study sites to collect study documentation, resolves issues and requests outstanding information.
• Provide general support to the CRAs to manage investigational sites and ensure protocol and regulatory compliance
• Remotely reviews EDC
• Remotely reviews drug accountability log (when possible)
• Ensures study systems are updated per agreed study conventions (e.g. CTMS)
• To assist local SSU specialist with contracts negotiations and RGL's site documentation
• Perform QC of the eTMF (country/site level) for a certain study
• Assist investigational sites with study start-up activities to ensure study specific supplies are received
• Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc.) as needed
• To contact Clinical sites for specific requests between visits:
o Enrollment updates, challenges with recruitment, supplies
o Missing TMF documentation
o Data entry timelines, data query follow-up
o Follow-up on action items from previous site visits
• Track patient enrollment and assist with recruitment efforts by maintaining regular site contact
• To assist CRAs with preparation and follow-up for all types of site visits (Communicating data entry, queries, tracking reports IRT/DM/Imaging/eCOA/Labs, TMF support and maintenance, site performance, point of escalation, etc.)
• Serve as primary CRA back-up for the site
• May assist with tracking project specific training for site personnel
• Conduct Pre-Study visits and/or Close-out Visits as needed; Independently as approved
• Co-monitor on assigned studies as needed
• Assist with site quality management activities, including site audits and site inspections
• Assist the CRA with Action Item and Protocol Deviation review and follow-up
• Maintain FAQ list for assigned studies, as needed
• Document site and sponsor contact and study interactions in a timely and professional manner
• Assist with resolution of investigational site data queries, especially during interim activities and DB Lock
• May provide study-specific direction, training, and mentoring to the monitoring team members

Qualifications

What we're looking for
 Position requires BA/BS preferably in the Life Sciences, or RN
 Minimum of 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator
 Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
 Strong knowledge of concepts of clinical research and drug development
 Strong working knowledge of EDC, IVRS and CTMS systems
 Proficient in the use of Microsoft Office
 Ability to work highly independently across multiple studies, projects and sites.
 Ability to work effectively in a team/matrix environment.
 Ability to understand technical, scientific and medical information.
 Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills
 Works with high quality and compliance mindset
 Possess a valid driver's license
 Must be willing to travel
 ExUS: Proficient in speaking and writing English and the country language when applicable.

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.