Research Specialist 2, Clinical Research Operations Office - Georgetown University Medical Center

5 days left

Location
Washington D.C.
Posted
Jul 30, 2018
Closes
Nov 24, 2018
Industry
Education, Research
Hours
Full Time
Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Research Specialist 2, Clinical Research Operations Office - Georgetown University Medical Center

The mission of Georgetown's Clinical Research Operations Office (CROO) is to provide services to: ● Georgetown researchers, assisting with study start-up and administration; ● Patients and the general public, providing up-to-date information about ongoing clinical studies at Georgetown University Hospital Medical Center (GUMC); ● and Sponsors, helping them identify GU investigators for participation in their research.

The Research Specialist 2 is a team lead responsible for, and critically important to, the overall operational management of clinical research activities, and has as direct responsibility for implementing a diverse portfolio of research activities for studies spanned across multiple disciplines. S/he performs  expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, leadership skills, effectively working with a variety of people and organizations GUMC and elsewhere, exhibiting an in depth knowledge of specific programs. Reporting to the Clinical Research Manager and Principal Investigator, the D has duties that include but are not limited to:

Mentorship and Training

  • Works directly with Manager of Central Research Support Services to provide mentorship and training for junior level CRC roles (Clinical Research Coordinator, Clinical Research Coordinator I).
  • Assists in the completion of CRC competency checklists under the supervision of the Manager of Central Research Support Services.
  • Networks and builds trusting relationships with potential GUMC CRC pool users.
  • Participates in GUMC activities to promote the CRC pool.

Departmental Support

  • Provides CRC support to multiple departments and projects conducted at GUMC.
  • Liaises with sponsor regarding site management, data review, and query resolution issues, providing guidance and suggestion for resolution.
  • Provides strategic and operational regulatory guidance to internal project teams.
  • Completes and submits case report forms on as close to a "real time basis" as possible.

Research Participants

  • Ensures all research participants encounters are updated as appropriate and within 24 hours in OnCore CTMS
  • Collects, enters, and analyzes subject data, and compiles reports using OnCore CTMS.
  • Provides monthly enrollment numbers to the Manager of Central Research Support Services.

Collateral Duties

  • Submits study-specific time sheets weekly to the Manager of Central Research Support Services.
  • Attends monthly CROO meetings and weekly study team meetings.
  • Completes and maintains GCP and Human Subjects Protection Training.

Requirements

  • Bachelor's degree in a scientific or related field  - preference for Master's degree in related field
  • 3 to 5 years of clinical research experience - preference for supervisory experience
  • 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 demonstrated interpersonal, and 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

Preferred qualifications

  • Clinical Research Coordinator (CRC) and/or Clinical Research Associate (CRAA) certification
  • Fluency in spreadsheet software; ability to develop complex spreadsheets independently; and demonstrable skills in audit preparation, execution, and follow-up
  • Experience in risk management regarding study objects, 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.

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