Clinical Research Associate II (Trial Monitor) - Hybrid/Remote
REQUIRED QUALIFICATIONS:
Knowledge of:
- Clinical research study processes, study design and/or protocol management.
- Clinical trial monitoring procedures and clinical data reporting processes.
- ICH GCP guidance and FDA regulations.
- Medical terminology and anatomy/physiology.
- Microsoft Suite of software products.
- Intermediate project management, training, and conflict resolution skills.
Ability to:
- Perform tasks requiring excellent attention to detail.
- Manage multiple deadlines and priorities while ensuring quality and timeliness.
- Work effectively and efficiently in a remote environment.
- Travel anywhere from 25-50% travel, both domestic and international, depending upon assigned studies. Travel at times may increase up to 70% as required (domestic and international).
Education and/or Experience:
- Bachelor’s degree in healthcare/science related field.
- Minimum of two years’ experience monitoring clinical research studies and/or protocol management according to ICH GCP/FDA guidelines or verifying clinical data from medical records.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Functional knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
- ACRP or SOCRA certification.
DEI COMMITMENT:
As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.
BENEFITS:
NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information