Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.)
Monitor investigator sites with a risk-based monitoring approach
Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
Document observations in reports and letters in a timely manner using approved business writing standards
Conducts monitoring tasks in accordance with the approved monitoring plan
Ensures study systems are updated per agreed study conventions
Facilitate effective communication between investigative sites, the client company and the PPD project team

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years as an on-site clinical research monitor) or completion of PPD Drug Development Fellowship
Oncology, Neurology, and/or Ophthalmology therapeutic experience is highly preferred
Valid driver's license where applicable
Must be legally authorized to work in the United States without sponsorship

A choice of national medical and dental plans, and a national vision plan
A wellness program, and valuable health incentive opportunities for company contributions to Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA)
Tax-advantaged savings and spending accounts and commuter benefits
Employee assistance programs
At least 120 hours paid time off (PTO)
10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short
and long-term disability, and volunteer time off in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Clinical Research Associate II – Oncology, Neurology, Ophthalmology

Key skills