FSP CRA II (Neuro & Rare Disease) - US West

Overview

Clinical Research Associate (Level II) who performs and coordinates all aspects of clinical monitoring and site management, conducting remote or on-site visits to assess protocol and regulatory compliance.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previous issues and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with project team members for issue and finding resolution, investigating and following up on findings as applicable.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol, regulatory and ICH GCP obligations, making recommendations where warranted.
• Perform trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place per ICH-GCP and applicable regulations; conduct on-site file reviews per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required, and keep study systems such as the Clinical Trial Management System updated per agreed study conventions.
• Facilitate effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements, audits and inspections.
• Complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas, and contribute to process improvement initiatives as required.

What you'll need

• Bachelor's degree in a life sciences related field, or a Registered Nursing certification or equivalent, and relevant formal academic / vocational qualification.
• Previous experience providing the knowledge, skills and abilities to perform the job (comparable to 1 year as a clinical research monitor), or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain working knowledge of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Customer focus through good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Good organizational and time management skills.
• Effective interpersonal skills and attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills; good presentation skills.

Details

• Location: Remote, California, USA.
• Work schedule: Standard (Mon-Fri).
• Travel: frequent drives to site locations; frequent travel, generally 60-80% but more for some individuals, may include extended overnight stays.
• Working conditions: office, laboratory, clinical and/or home office environment; exposure to biological fluids with potential exposure to infectious organisms; personal protective equipment required; rare exposure to fluctuating and/or extreme temperatures.
• Salary range for California: $57,100.00–$87,125.00; may be eligible for a variable annual bonus.