Lead Clinical Research Associate
RemoteUnited States
Job Summary
Monitor project timelines, patient enrollment, and data cleaning while implementing corrective and preventive measures. Review monitoring visit reports, manage query resolution, and oversee source data verification and study risks at the site and country levels. Act as the primary communication line between monitors, site management, and project leads, leading country-level team calls and providing status updates. Provide project-specific training, supervise Investigator Site File reconciliation, and coordinate safety information flow and protocol deviations. Manage clinical supplies with vendors, conduct supervised monitoring visits, and oversee CAPA development and process deviation reporting. Prepare draft regulatory and ethics submission packages and deliver presentations at investigator meetings.
Required Qualifications
- Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience
- Minimum of 4 years' site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level
- Experience with all types of monitoring visits in Phase II and/or III
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Excellent Communication, collaboration, and problem-solving skills
- Ability to travel
- Valid driver's license (if applicable)
- For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future
Desired Qualifications
- Strong experience in Oncology preferred
- Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred
- Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred
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