Clinical Research Associate - MedTech CRO (Onsite, Germany)

About RQM+

RQM+ is a leading MedTech Contract Research Organization dedicated to accelerating patient impact by providing comprehensive regulatory and quality expertise, FDA-recognized laboratory services, clinical trial management, and reimbursement strategies across diverse device types and therapeutic areas. Our mission is to facilitate the successful development and approval of medical technologies, enhancing patient outcomes with speed and safety.

Our teams are collaborative, adaptive, and customer-centric, maintaining transparent communication and fostering strong client and site relationships. We provide real-time data access through cutting-edge technology platforms to ensure study transparency.

Role Overview

The Clinical Research Associate (CRA) supports all stages of clinical investigations from pre-market to post-market. Duties include site qualification, initiation, monitoring visits, and study close-out activities conducted onsite. The CRA monitors adherence to Good Clinical Practice (GCP) and ISO 14155 standards, coordinating closely with Project Managers and Lead CRAs to meet study protocols and timelines.

Key Responsibilities

• Engage in investigator recruitment and conduct site qualification assessments to evaluate capability for clinical research.
• Collaborate with start-up teams for site preparation and initiation activities including training on study plans, electronic Case Report Forms (eCRF), and monitoring procedures.
• Manage regulatory documentation and approvals from Institutional Review Boards, Ethics Committees, and Competent Authorities to facilitate study implementation and monitoring.
• Train site personnel on the Electronic Data Capture (EDC) system and ensure appropriate site computer system validation.
• Conduct on-site monitoring to ensure compliance with GCP/ISO 14155, verifying source documentation and eCRF data integrity.
• Oversee investigational product accountability, storage, return, and disposal per sponsor requirements.
• Serve as liaison between RQM+, sponsors, and investigative sites, maintaining clear communication and timely data exchange.
• Execute study close-out procedures including final reconciliation, site file audits, data query resolution, and database lock preparation.
• Assist with investigator meetings and support mentoring junior staff members.
• Participate in study-related training sessions and attend internal and external meetings as needed.

Required Qualifications and Experience

• Degree in life sciences or an allied health profession (e.g., nursing, medical technology) or equivalent professional certification.
• Alternatively, relevant clinical research experience within pharmaceutical, CRO, or related sectors will be considered.
• Working knowledge of ICH-GCP guidelines, regulatory clinical trial procedures, and medical terminology.
• Competence in clinical data review, source document verification, and resolution of data discrepancies within defined timelines.
• Strong communication skills in German (excellent), English (proficient), and preferably French (advantageous).
• Ability to comprehensively review study protocols, investigator brochures, SOPs, and ancillary documentation.
• Proficiency in Microsoft Office Suite and electronic data capture systems.
• Committed to customer-focused interactions, fostering effective collaboration with internal and external stakeholders.
• Willingness and ability to travel frequently (approximately 40–70%).

Behavioral Attributes

• Action-oriented with a proactive approach to tasks.
• Team-player fostering effective collaboration.
• Strong business acumen and decision-making skills.
• Committed to integrity, trust, and customer focus.
• Ability to maintain composure and demonstrate courage in managerial settings.

Work Environment and Equal Opportunity

• This role operates in a professional office and clinical environment, requiring use of standard office equipment and occasional physical activities such as sitting, stooping, and balancing.
• RQM+ promotes equal employment opportunities for all, ensuring a workplace free from discrimination or harassment across protected characteristics.

Additional Information

RQM+ prioritizes employee development through continuous learning and offers a competitive compensation package alongside a strong work-life balance culture. Candidates can expect an inclusive environment where every team member is valued as part of the RQM+ family.

Note: All legitimate RQM+ job openings are publicly listed, and candidate interviews will involve voice/video steps to maintain security. Applicants should be vigilant regarding unsolicited offers or requests for sensitive data.