Parexel FSP is looking for a Sr CRA / CRA in the MIDWEST REGION of the United States!
Oncology experience required.
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