Senior Clinical Research Associate - Poland

Everything we do has the potential to impact patient lives, and our Senior Clinical Research Associates (SCRA) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client, and site satisfaction.

As a SCRA at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Position Purpose:

The SCRA with the support of Clinical Research Associate (CRA), Clinical Research Associate - Manager (CRAM) and/or Partner Line Manager (PLM) will act as a primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Primary Duties:

·      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:

·      Data generated at site are complete, accurate and unbiased.

·      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.

·      Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and various other systems as appropriate and per timelines.

·      Supports and/or leads audits/inspection activities as needed.

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

Skills and Education:

·      B.A./B.S. preferred with a strong emphasis in science and /or biology.

·      Minimum 3 years of direct site management (monitoring) experience in bio/pharma/CRO required: Note: No compromise on minimum monitoring.

·      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.

·      Fluent in local languages and English (verbal and written) and excellent communication skills.

·      Preferred: located Northern Poland (Koszalin, Bydgoszcz, Poznań, Trójmiasto) or central Poland.