Senior Clinical Research Associate

3 days ago

Reston, Virginia, United States Parexel Full time
About the Role

Parexel is seeking a highly skilled Senior Clinical Research Associate to join our team in the Minnesota, North Dakota/South Dakota area.

Key Responsibilities
  • Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
  • Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
  • Perform 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.
  • Gain an in-depth understanding of the study protocol and related procedures.
  • Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participate & provide inputs on site selection and validation activities.
  • Perform remote and on-site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased, and subjects' right, safety and well-being are protected.
  • Conduct 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.
  • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
  • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Identify, assess, and resolve site performance, quality or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager.
  • Manage and maintain 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
  • Contribute 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.
  • Support and/or lead audits/inspection activities as needed.
  • Mentor / buddy junior CRAs on process/study requirements.
  • Contribute to initiatives and projects adding value to the business.
  • Perform 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 comply with Parexel/Client processes, ICH-GCPs and other applicable requirements.
Requirements
  • Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.
  • 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.

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