Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documents
Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures
Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages
Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities
Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise
Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders
Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases
Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
Collaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialists

Requirements

Bachelor's degree in a related field
Minimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA I
In-depth knowledge of clinical trial processes and regulations
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Strong scientific background
Strong experience in Cell & Gene Therapy
Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Proficiency in clinical trial management systems and software
Ability to manage multiple projects and priorities
Strong attention to detail and organizational skills
Ability to travel as required for on-site monitoring
Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Benefits

company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical research monitoringclinical trial processesregulatory compliancedata managementprotocol deviations resolutionadverse events managementmonitoring plans developmentstandard operating proceduresanalytical skillsproblem-solving skills

Soft Skills

communication skillsinterpersonal skillsteamworkindependenceattention to detailorganizational skillsmentoringcollaborationtrainingfacilitation

Certifications

Certified Clinical Research Associate (CCRA)