Parexel FSP is looking for a Sr CRA/CRA in the Minnesota, North Dakota/South Dakota area!
Job Purpose:
The Senior Clinical Research Associate is responsible for the following:
• Act as the primary site contact and site manager throughout all phases of a
clinical research study, taking overall responsibility of allocated sites.
Key Accountabilities:
Site Management Responsibilities
• 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 Good Clinical Practice (GCP) / International Council for Harmonization (ICH), 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, closeout 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 Manager and Partner Line Manager
• Manages and maintains information and documentation in Clinical Trial Management System, Electronic Trial Master File and various other systems as appropriate and per timelines
Team Development and Support
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required
• Supports and/or leads audits/inspection activities as needed
• Mentors / buddies junior CRAs on process/study requirements
• Contributes to initiatives and projects adding value to the business
• Performs co-monitoring as appropriate
Compliance with Parexel Standards
• Comply with required training curriculum
• Complete timesheets accurately as required
• Submit expense reports as required
• Update CV as required
• Maintain a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements
Skills:
• Fluent in local languages 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 and country clinical research law and guidelines
• Hands on knowledge of Good Documentation Practices
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Demonstrated ability to mentor/lead
• Proven skills in Site Management including independent 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 appropriately
• Experience with conducting site motivational visit designed to boost site enrollment
• Capable of managing complex issues, works in a solution-oriented manner
• Performs root cause analysis and implements preventative and corrective action
• Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• Able to work highly independently across multiple protocols, sites, and therapy areas
• High sense of accountability / urgency
• Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment; ability to establish and maintain culturally sensitive working relationships
• Demonstrates commitment to customer focus
• Works with high quality and compliance mindset
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
• Ability to travel domestically and internationally approximately 65%-75% of working time
• Expected travelling ~2-3 days/week
• Current driver’s license required
Knowledge and Experience:
• Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO
Note: Specific monitoring or therapeutic experience/requirements may vary depending on the Country or study needs
Education:
• Bachelor’s degree preferred with a strong emphasis in science and /or biology
