Lead Clinical Research Coordinator - Georgetown University Medical Center

Job description



Lead Clinical Research Coordinator - Georgetown University Medical Center

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

The Lead Clinical Research Coordinator (Sr. CRC) is a team lead position title in the Clinical Research Coordinator Family. With minimal supervision, the Sr. CRC has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials. This position 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 and other research staff).

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.
  • 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), Standard Operating Procedures (SOPs).


Study Management
  • Performs all duties of the Lead Clinical Research Coordinator role including study initiation, enrollment, conduct and closeout.
  • Prepares and compiles data and documents during internal and external audits, and is ultimately responsible for quality of submissions.
  • Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.


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


Regulatory
  • Manage 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


The Lead Clinical Research Coordinator is required to comply with institutional policies regarding clinical research participant studies, regulatory and data management and usage of OnCore Clinical Trial Management System (CTMS) as applicable.

Work Interactions

The Lead CRC will work directly under the Clinical Research Services manager to conduct and manage study related activities. The incumbent will receive little supervision and mentors, trains and reviews the work of less experienced clinical research staff including study coordinators, data managers and regulatory coordinators. This position interacts directly with patients and research participants. They are responsible for direct communication with multiple institutional departments as well as the Sponsor and/or Clinical Research Organization (CRO) managing the research study and all regulatory boards.

Qualifications
  • Bachelor's degree in a scientific or related field with a minimum of 5-7 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 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.
  • Ability to manage other research staff


Preferred Qualifications
  • Master's degree in related field and supervisory experience strongly preferred.
  • Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification is preferred. Certification is required within one year of eligibility.
  • Fluency in spreadsheet software; 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:

If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.

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 [email protected].

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-----Georgetown-University-Medical-Center_JR10300





Copyright ©2017 Jobelephant.com Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency

jeid-f383c8e8a07db04eb3f4f0babcfe5b57

 

 

 

Diversity Profile: University

 

AAUP COMPENSATION SURVEY DATA

View more

Learn more on Inside Higher Ed's College Page for University

Arrow pointing right
Job No:
Posted: 6/7/2021
Application Due: 6/7/2033
Work Type: Full Time
Salary: