Description

In-house CRA Germany

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.