Sr. Clinical Research Coordinator

Clinical Research Analyst

Under general supervision, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops protocols. Develops work flow policies and procedures. Mentors, trains and reviews the work of less experienced clinical research staff. Oversees the clinical assessments of the study subjects. Assists with protocol submissions, database enhancements, and budget preparation.

Essential Duties and Responsibilities:

• Analyzes 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 work flow 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.
• Independently obtains informed consent for all types of clinical studies and educates participants regarding study requirements.
• Performs other related duties.

Skills:

• Previous Experience: 3 years of clinical research experience
• Strong Knowledge of Industry sponsored clinical research
• Excellent written and oral communication skills
• Exceptional attention to detail and accuracy
• Ability to manage multiple tasks; priorities
• Knowledge of variety of concepts, practices and procedures in directly related field
• Able to hit the ground running with limited training

Education:

Required: Bachelor's degree in sciences or related field.

Preferred: Clinical Research Coordinator Certification granted by the Association of Clinical Research Professionals.

Schedule Notes: 9-5