Hybrid Senior Clinical Research Associate, Field Monitor

Posted last month

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About the role

  • Participate in clinical research teams to ensure effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support
  • Develop, review and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
  • Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods
  • Communicate scientific rationale for assigned studies to team members and clinical sites
  • Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
  • Create/edit, distribute and collect site feasibility questionnaires
  • Oversee and support collection of essential documents during study start-up
  • Collect study and site metrics and maintain study trackers
  • Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed
  • Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits
  • Partner with field CRAs to resolve issues identified during site visits
  • Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) and resolve IP temperature monitoring excursions and train or assist sites with corrective actions
  • Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
  • Clinical specimen log review and coordinating shipment of specimens to the sponsor or contracted vendor
  • Conduct remote monitoring tasks including reconciliation of site investigational product accountability
  • Provide mentorship and training to newly hired research staff
  • Perform other duties as assigned

Requirements

  • Bachelor’s degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting; or a high school diploma with 8 years of experience in a clinical research setting
  • Minimum of 2 years’ experience as a Clinical Research Associate II or higher required
  • Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
  • Excellent written/oral communication skills
  • Strong organizational and multi-tasking skills
  • Understand the job-specific system, processes as defined by the company’s SOPs, and adhere to the requirements listed in those documents
  • Maintain corporate confidentiality at all times
  • Ability to set priorities and independent decision making
  • Ability to work independently as well as in teams
  • Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues
  • Outgoing and confident demeanor
  • Independent thinker and persuasive communicator
  • Detail oriented, with solid organization and time management skills
  • Completes projects with reliability and minimal guidance
  • Knowledge of drug development process
  • Computer literacy: EDC, eTMF, CTMS, etc.
  • Working knowledge of ICH E6, and the Code of Federal Regulations
  • Must be able to travel up to 75% of the time based on study requirements
  • Remote with ability to work flexible hours for various time zones

Benefits

  • Medical, Dental and Vision Plan Options
  • Health and Financial Wellness Programs
  • Employer Assistance Program (EAP)
  • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
  • Healthcare and Dependent Care Flexible Spending Accounts
  • 401(k) Retirement Plan with Company Match
  • 529 Education Savings Program
  • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  • Paid Time Off (PTO) includes: 11 Holidays
  • Exempt Employees are eligible for Unlimited PTO
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
  • Discretionary bonus and equity award eligibility
  • Professional development opportunities
  • Tools and resources to optimize Health and Wellness

Job title

Senior Clinical Research Associate, Field Monitor

Job type

Experience level

Senior

Salary

$128,000 - $140,000 per year

Degree requirement

High School Diploma

Location requirements

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