Study Start-Up Specialist - Remote

REQUIRED QUALIFICATIONS:

Knowledge of:

• Clinical research study processes and protocol management.
• Medical terminology and anatomy/physiology.
• ICH GCP guidance and FDA regulations.
• Computer proficiency, including the use of standard business and clinical research software (e.g., Microsoft Office Suite, databases, CTMS) and the use of internet.
• Training and conflict resolution skills.
• Quality assurance.

Ability to:

• Demonstrate excellent oral and written communication.
• Manage multiple deadlines and priorities while ensuring quality and timeliness.
• Perform tasks requiring excellent attention to detail.
• Demonstrate independent problem-solving and decision-making for straightforward situations, but requires guidance for complex situations.
• Must exemplify NMDP values in a highly professional manner in all settings.
• Adapt to change.
• Navigate processes and people involved in clinical research, demonstrating organizational awareness and interpersonal skills necessary to complete work efficiently.

Education and/or Experience:

• Bachelor’s degree in a scientific or health related field; however, upon evaluation, equivalent related experience or education may be substituted for the scientific or health-related degree requirement.
• Minimum of three years’ experience directly supporting clinical trials. Related advanced degrees may be considered in substitution for clinical trial experience.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
• ACRP or SOCRA certification.
• Experience with CRO teams and developing clinical strategies and study design.
• Experience leading study and site activation and reviewing informed consent forms.

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