Clinical Research Associate II - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Position Purpose: 

The Clinical Research Associate (CRA) will act as the 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 in collaboration with Clinical Research Associate-Manager (CRAM)/Clinical Research Manager (CRM), Partner Line Manager (PLM) 

• 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 audits/inspection activities as needed 

• Performs co-monitoring visits where appropriate 

• Experience or ability to support and/or lead audit/inspection activities as needed 

• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training 

• Adheres to EP and Client SOPs and processes 

Skills and Education: 

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

• Minimum 2 years of direct site management (monitoring) experience in bio/pharma/CRO required 

Note: No compromise on minimum monitoring experience however specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs 

• 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 judgement 

• 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 appropri