Cancer Center Jobs

CRMO Clinical Research Manager

Georgetown Lombardi Comprehensive Cancer Center

April 3, 2019
CRMO Clinical Research Manager - Georgetown University Medical Center

Requirements

The Clinical Research Management Office (CRMO) is a shared institutional resource of the Lombardi Comprehensive Cancer Center at Georgetown that provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. The Clinical Research Manager oversees the implementation of clinical trials in the Lombardi Comprehensive Cancer Center ClRMO to ensure compliant management and support of clinical trials.  S/he provides expert level knowledge in clinical trial practices and regulations. Working under the direct supervision of the CRMO Administrative Director and CRMO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials, the Clinical Research Manager has duties that include but are not limited to:

Guides and directs a team of clinical research nurses and coordinators assigned to the various disease teams within the CRMO.
Provides support, direction and coaching to clinical research coordinators in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
Provides daily management/supervision to the clinical research coordinators to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities within the CRMO.
Oversees adherence to SOPs, Good Clinical Practice, and FDA regulations.
Ensures that accrual data and each subject data is entered into the study calendars in Clinical Trial Management System (CTMS) OnCore.
Assists CRMO leadership in developing strategic planning goals and initiatives for clinical research.
Liaises and works efficiently with other department at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.
Interacts on a daily basis with the CRMO Regulatory Manager, CRMO Senior Data Managers and CRMO Lab and Imaging Technicians to ensure all protocol requirements are met.
Works with study sponsors, IRB, and other regulatory offices as needed.

Qualifications

Bachelor’s degree, preferably in a scientific field
5 years of clinical research experience
Knowledge of clinical research, human subjects research ethics, and IRB procedures
Advanced knowledge of human subject’s research ethics and clinical trial practices and policies to include ICH, GCP, FDA regulations, complex visit structures, budgets and contracts

Knowledge of medical terminology as well as the policies and regulations relevant to oncology clinical trials

Ability to build, lead, motivate, and assess a professional team

Excellent verbal and written communication skills in daily interactions with the ability to interpret and apply GUMC policies and federal, state, and local regulations

Strong organizational skills with the ability to manage large volumes of information

Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies

Knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)

Preferred Qualifications

Master’s degree in in scientific field with at least 3 years of supervisory experience
Nursing Degree and experience with management of oncology trials
Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA) certification

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law.