Senior Clinical Research Associate (m/f/d)

Job Description

We aspire to be the premier research-intensive biopharmaceutical company in the world.

We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases, such as HIV and Ebola, and emerging animal diseases.

Our purpose is to save and improve lives for generations. Our strategy is simple: We follow the science. The path to discovery is often unclear, but we are tireless in seeking solutions for some of the world’s most difficult health challenge

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

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.

• 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 internally 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.

• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

• Supports and/or leads audit/inspection activities as needed.

• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate

Experience and Educational Requirements:
• Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO.
Or
• Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO.

Required Experience and Skills:  

• Fluent in Local Language and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Demonstrated ability to mentor/lead.

• Hands on knowledge of Good Documentation Practices.

• Proven Skills in Site Management including independent management of site performance and patient recruitment.

• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet an