Clinical Trials Manager - School of Medicine, Emergency Medicine

About the role

This position oversees the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials. The role typically supervises a staff of 2-5 employees, trains new clinical trials staff, tracks enrollment, sponsor payments, and salary, and provides leadership in business development.

Responsibilities

• Manages financial, regulatory, patient management, and human resources functions associated with conducting clinical trials.
• Trains new clinical trials staff.
• Tracks enrollment, sponsor payments, and salary.
• Provides leadership in business development.
• Assists residents in preparing research projects by facilitating IRB submissions and protocol writing.
• Responsible for preparing NIH proposals and routing through the system.
• Assists in creating and maintaining Standard Operating Procedures.
• Performs related responsibilities as required.

Additional Job Details

• Provides leadership and oversight of significant clinical research project(s) with an emphasis on managing, evaluating, and training research staff.
• Recruits, orients, and typically manages a research and administrative staff of eight to fifteen employees.
• Plans protocol, develops policies and establishes standards for the research unit.
• Develops and writes proposals for grants to conduct research.
• Manages research studies and related protocols.
• Affords assistance to the medical staff and community outreach.
• Develops and provides educational information and expertise in research protocol and research-driven treatment modalities.
• Collaborates with others to develop and oversee effective internal quality assurance and control procedures.
• Demonstrates a knowledge of and competency in all regulatory requirements (FDA, GCP, ICH and HIC).

Qualifications

• A bachelor's degree in a related field and seven (7) years experience in clinical trials, two of which are in the clinical area.
• A master's degree and four years of experience in clinical trials, one of which is in the clinical area will be considered equivalent.
• Six years clinical trials research experience which includes previous project management or leadership experience.
• Current supervisory or managerial experience.
• Experience with trial management, including contracting and IRB management.
• Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC).
• Previous grant writing experience.
• Knowledgeable and proficient in the use of various computer applications/systems.

Skills

Knowledgeable and proficient in the use of various computer applications/systems.

Benefits

N/A

Pay

N/A

Schedule

N/A