Clinical Trials Manager - School of Medicine, Emergency Medicine

Emory•Atlanta, GA

About The Position

Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description JOB DESCRIPTION: Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials. Typically 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. 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. 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.

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.)