Senior Clinical Research Coordinator - Georgetown University Medical Center

Location
Washington D.C.
Posted
May 08, 2018
Closes
May 21, 2018
Function
Analyst, Research
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

Senior Clinical Research Coordinator - Georgetown University Medical Center

Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center whose missions of research, teaching and patient care are carried out with a strong emphasis on community outreach and the Jesuit principle of cura personalis - care of the whole person.  GUMC consists of the School of Medicine, the School of Nursing & Health Studies, Georgetown Lombardi Comprehensive Cancer Center, and Biomedical Graduate Research and Education.

The Senior Clinical Research Coordinator is a team lead position in the Clinical Research Coordinator Family with direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials. S/he performs expert and efficient integration of multiple complex programmatic activities, applying a sophisticated knowledge of clinical trials, leadership skills, and effectively working with a variety of people and organizations at GUMC (clinicians, investigators, clinical staff, administration, regulatory, contracts and grants).

Study Management

  • Performs all duties of the Clinical Research Coordinator II role including study initiation, enrollment, conduct and closeout.
  • Prepares and compiles data and documents during internal and external audits
  • Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.

Departmental

  • Coordinates multiple clinical trials simultaneously, and manages multiple Principal Investigator relationships.
  • Serves as point person and lead for all clinical trials.
  • Assists with or plans and implements the clinical study's goals and objectives, including organizing patient enrollment planning, meeting enrollment goals, and compiling and analyzing data.
  • Serves as the liaison with the sponsor for assigned studies.
  • Mentors, trains, and reviews the work of CRC, CRC I and CRC II on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).

GUMC Requirements

  • Complies with all GUMC and Clinical Trial Management procedures, as well as all Medicare compliance procedures.
  • Complies with all GUMC training requirements as applicable to position (CITI, COI, ACRP/SOCRA or equivalent, Bloodborne Pathogens, Billing Compliance).
  • Attends a minimum of 6 GUMC research meetings (CRN, CROO, LCC) per year.
  • Completes and uploads time & effort forms on-time each month into designated university Box folder.
  • Enter all study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.

Regulatory

  • Manages IRB submissions and develop regulatory submission strategies as applicable.
  • Prepares 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 

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

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, 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 (CCRC) and/or Clinical Research Associate (CCRA) certification
  • Fluency in spreadsheet software and ability to develop complex spreadsheets independently
  • Demonstrable skills in audit preparation, execution, and follow-up
  • Experience in risk management regarding study subjects, federal and non-federal sponsors. and regulating bodies

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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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