Clinical Trials Manager - School of Medicine, Emergency Medicine

Emory University • Atlanta, GA

5d • Hybrid

About The Position

Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials. 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. Acts as a resource person for 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.)

Requirements

• 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.
• Demonstrates a knowledge of and competency in all regulatory requirements (FDA, GCP, ICH and HIC.)

Nice To Haves

• Six years clinical trials research experience which includes previous project management or leadership experience.
• Two years of supervisory or managerial experience.
• Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC).
• Previous grant writing experience.
• Knowledgeable and proficient in the use of various computer applications/systems.
• May be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents.

Responsibilities

• Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials.
• Supervises a staff of 2 - 5 employees.
• 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.
• 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.
• Acts as a resource person for 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.)

Benefits

• Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law.
• Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
• Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination.
• Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities).
• Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager