Clinical Research Operations Lead

Mount Sinai; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Mount Sinai Health System in the United States is seeking a skilled clinical research professional to generate, reconcile, and interpret highly complex data from clinical studies. You will oversee protocol development, testing, and data workflows while mentoring junior staff and coordinating between multiple sites.

The role involves supporting budget processes, IRB submissions, and ensuring regulatory compliance throughout ongoing trials.

Qualifications

• Bachelor's degree in sciences or related field.
• Master's degree preferred.
• 5 years of clinical research.

Responsibilities

• Generates highly complex data gathered on clinical research studies.
• Interprets complex clinical research data.
• Conducts clinical testing, develops protocols and assures all protocol procedures are approved.
• Prepares reports for presentation in conferences and seminars.
• Mentors, trains and reviews the work of less experienced clinical research staff.
• Develops workflow policies and procedures, prepares manuals and documents related to operations of the function.
• Oversees the clinical assessments of the study subjects including but not limited to screening, evaluation and testing of the subjects.
• Oversees data collection, processing, storage, inventory and quality control for clinical research studies.
• Assists in budget preparation and negotiation.
• May prepare and ensure grant applications, IRB / GCO documents are submitted.
• Coordinates protocols and human subject approvals between various sites.
• Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
• May obtain informed consent under general supervision of the Investigator(s) and educate participants regarding study requirements
• Performs other related duties.

Skills

MS Excel

MS Word

Outlook

SSPS/SAS

Education

Bachelor's degree in sciences or related field

Master's degree preferred

Tools

Microsoft Access

Job description

Mount Sinai Health System in the United States is seeking a skilled clinical research professional to generate, reconcile, and interpret highly complex data from clinical studies. You will oversee protocol development, testing, and data workflows while mentoring junior staff and coordinating between multiple sites.

The role involves supporting budget processes, IRB submissions, and ensuring regulatory compliance throughout ongoing trials.