Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Lead Clinical Research Coordinator - Georgetown University Medical Center
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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).
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).
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.
Assists in the financial accounting of multiple clinical research projects, including budget development and billing reconciliation.
Oversee research participant stipends.
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.
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.
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
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.
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