Description
In-house CRA Germany
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
For one of our clients we will be looking for an in-house CRA.
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 properly communicated to the site and CRAs.
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
To contact Clinical sites for specific requests between visits: enrollment updates, challenges with recruitment, supplies, missing TMF documentation, data entry timelines, data query follow-up, 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
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
Assist with preparing the IRB related documents and materials for the submission
Qualifications:
Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Minimum of 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator
Strong organizational skills.
Ability to manage time and work independently.
High proficiency with full MS Office Applications.
Fluency in German and a high level of competence in English language
Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
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.
http://www.syneoshealth.com
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.
Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.
