Lead Clinical Research Coordinator, Biomedical Graduate Research Organization - Georgetown University Medical Center

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Requirements

Lead Clinical Research Coordinator, Biomedical Graduate Research Organization - Georgetown University Medical Center

Georgetown University Medical Center (GUMC) - as one of approximately 140 academic health and science centers in the United States - seeks to provide, in a synergistic fashion, excellence in education — training physicians, nurses and other health care professionals, as well as biomedical scientists — and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health.

The Lead Clinical Research Coordinator (CRC) implements a diverse portfolio of research activities within GUMC's Biomedical Graduate Research Organization for one or more studies which may include multicenter clinical trials, and performs expert and efficient integration of multiple complex programmatic activities, applying a sophisticated knowledge of clinical trials and leadership skills. They interact directly with patients and research participants and directly communicate with multiple institutional departments, as well as the Sponsor and/or Clinical Research Organization (CRO) managing the research study and all regulatory boards.

Reporting directly to the Clinical Research Services Manager, and training and reviewing the work of less experienced clinical research staff, including study coordinators, data managers and regulatory coordinators, the Lead CRC has duties that include but are not limited to:

Departmental

• Coordinate multiple clinical trials simultaneously, and manage multiple Principal Investigator relationships
• Serves as point person and lead for all clinical trials for all CRCs and data mangers
• Assist with or plan and implement the clinical study's goals and objectives including the ability to organize patient enrollment planning and meet enrollment goals; compile and analyze data
• Serve as the liaison with the sponsor for assigned studies
• Mentor, train and review the work of CRC, CRC I and CRC II on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs)

Study Management

• Perform all duties of the Lead CRC role, including study initiation, enrollment, conduct and closeout
• Prepare and compile data and documents during internal and external audits, and take responsibility for quality of submissions
• Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected

Regulatory

• Manage IRB submissions and develop regulatory submission strategies as applicable.
• Prepare documents and reports for the IRB including IND Safety Letters, Protocol Amendments, Continuing Review Reports, Protocol Violations and Deviations, and Serious Adverse Event Reports as necessary

Financial

• Assist in the financial accounting of multiple clinical research projects, including budget development and billing reconciliation
• Oversee research participant stipends

Qualifications

• Bachelor's degree in a scientific or related field and at least 5 to 7 years of clinical research experience [An equivalent combination of education and experience may be substituted]
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures
• Significant clinical trial management experience including regulatory and compliance responsibilities
• Exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions
• Excellent interpersonal, verbal and written communication skills
• Ability to operate effectively in a changing organizational and technological environment
• Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
• Ability to interpret and apply GUMC policies and federal, state, and local regulations
• Ability to manage other research staff

Preferred qualifications

• Master's degree in related field
• Supervisory experience
• Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification [certification is required within one year of eligibility]
• Fluency in spreadsheet software and the ability to develop complex spreadsheets independently
• Demonstrated skills in audit preparation, execution, and follow-up
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies

Current Georgetown Employees:

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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.

Benefits:

Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Lead-Clinical-Research-Coordinator--Biomedical-Graduate-Research-Organization---Georgetown-University-Medical-Center_JR10542





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