Clinical Research Associate m/f/d

Job Description

As part of a dynamic and passionate team, the Clinical Research Associate is the laboratory's ambassador to the centers, and the defender of the entire product portfolio.
He/she plays a key role in all phases of a study, and assumes overall responsibility for the conduct of clinical studies at assigned sites.

Responsibilities include, but are not limited to:

• 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 CRA Manager, CRM, TA Head and CRD as needed.

• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.

• 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.

• Performs co-monitoring visits where appropriate.

• Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

CORE Competency Expectations:

• Fluent in Local Languages 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.

• Ability to understand and analyse data/metrics and act appropriately.

• Capable of managing complex issues, works in a solution-oriented manner.

• Performs root cause analysis and implements preventative and corrective action.

Behavioural Competency Expectations:

• Demonstrated high level of monitoring skill with independent professional judgement.

• Able to work highly independently across multiple protocols, sites and therapy areas.

• Positive mindset, growth mindset, capable of working independently and being self-driven.

Experience Requirements:

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements: Preferred: B.A./B.S. with strong emphasis in science and/or biology

Our offer :

- Full training and support for employees
- Career opportunities within the laboratory

- Very attractive package with target bonus, profit-sharing, vacation vouchers
- Flexible working conditions

Current Employees apply HERE<