Clinical Research Associate - FSP

 
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.

• Oncology experience preferred - but multi-specialty also encouraged to apply
• All US locations - West and Central preferred

• The 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
• Job Description
• 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 International Conference on Harmonization / Good Clinical Practices, 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready  Participates and 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, 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 to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required  Supports and/or leads audits/inspection activities as needed  Performs co-monitoring visits where appropriate  Compliance with Parexel Standards Complies with required training curriculum  Completes timesheets accurately as required  Submits expense reports as required  Updates CV as required  Maintains 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  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 appropriately  Capable of managing complex issues, working solution – oriented manner  Performs root cause analysis and implements preventative and corrective action  Effective time management, organizational and interpersonal skills, conflict management, problem solving skills  Demonstrated high level of monitoring skill with independent professional judgement  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 2 years of direct site monitoring experience in bio/pharma/CRO
• Note: Specific monitoring and therapeutic area 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