CRA (II/Sr), Oncology, client-dedicated, home-based, Germany

Syneos Health Careers; Deutschland; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Join a dynamic team as a Clinical Research Associate with a leading biopharmaceutical company dedicated to improving patients' lives. This role offers flexibility to match your experience level and involves managing site relationships throughout clinical trials. You'll ensure compliance with regulations while conducting monitoring activities both remotely and on-site. The company values diversity and fosters a culture where everyone can thrive. If you're passionate about making a difference in the clinical research field, this is your chance to grow your career in a supportive environment.

Leistungen

Comprehensive benefits program

Flexible work arrangements

Professional development opportunities

Qualifikationen

• Minimum 2 years of direct onsite monitoring experience in bio/pharma/CRO.
• Strong emphasis in science and/or biology required.

Aufgaben

• Acts as primary site contact and site manager throughout clinical research studies.
• Performs monitoring activities in compliance with ICH-GCP and local laws.

Kenntnisse

Onsite Monitoring

Clinical Research Knowledge

German Language

English Language

Communication Skills

Data Analysis

Good Documentation Practices

Ausbildung

Bachelor's Degree in Science/Biology

Tools

MS Office

CTMS

eTMF

Jobbeschreibung

Description

Clinical Research Associate - home based, sponsor dedicated, flexible level based on your work experience

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Here at Syneos Health we are currently recruiting for a Clinical Research Associate opening,to work on a sponsor-dedicated role in Germany. Based on your experience, we have the flexibility to adjust the role to the level of the successful candidate. The roles are part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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.

Your responsibilities:

• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased
o Subjects' right, safety and well-being are protected
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct,
recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed

Qualifications

What we're looking for
• Min B.A./B.S. required with strong emphasis in science and/or biology coupled with relevant work experience
• Min. 2 years of direct onsite monitoring experience of sites in a bio/pharma./CRO as a CRA (the more you have, the role will be adjusted to your level). Previous experience with monitoring Oncology trials in Germany
• Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Proven Skills in Site Management including management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyze data/metrics and act appropriately

• Willingness to perform 5-6 onsite monitoring visits per month, within Germany (the limit is 7-8, but usually it never really reaches this amount). Also, travel time is work time