Mgr, Clinical Research

Emory University - Atlanta, GA (30+ days ago)4.1


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.
Plans and develops budgets for new protocols. Regularly monitors expenses and receipts for active protocols.
Develops plans to ensure clinical research generates sufficient income to cover operating expenses.
Demonstrates a knowledge of and competency in all regulatory requirements (FDA, GCP, ICH and HIC.).
Submits applications and maintains Investigational New Drug (INDs) and Investigational Device Exemptions (IDEs) with the FDA.
Responsible for regulatory compliance at every level.
Develops and audits appropriate record-keeping procedures.
Develops and prepares operational and statistical reports for management and regulatory agencies.
Provides information for grant and contract applications and assists in the preparation of grants, contracts, and Requests for Proposal (RFPs).
Performs related responsibilities as required.

MUST BE Licensed as a Registered Nurse in the state of Georgia.
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) preferred.
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.