Clinical Trials Manager

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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.)

MINIMUM 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.

PREFERRED QUALIFICATIONS:

• 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.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

Additional Details

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). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

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Job Number 155476

Job Type Regular Full-Time

Division School Of Medicine

Department SOM: Emerg Med: Admin

Job Category Clinical Research

Campus Location (For Posting) : Location US-GA-Atlanta

Location : Name Steiner Building Grady Campus

Remote Work Classification Primarily On Campus

Health and Safety Information Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials