Lisa Marie Shepherd
Clinical Research Coordinator at Comprehensive Clinical Development- Claim this Profile
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Bio
Credentials
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GCP
EFGCP -- European Forum for Good Clinical Practice
Experience
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Comprehensive Clinical Development
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Research Coordinator
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2011 - Present
Promote safety and confidentiality of research participants at all timesAdhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control proceduresPlan and coordinate the initiation of research study protocol, and the implementation of operating policies and proceduresPlan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research dataRecruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scopeCoordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectivesOrganize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectivesDocument all correspondence and communication pertinent to the research. Interact and communicate effectively with Principal Investigator, other site personnel, research participants, Comply with all the rules and regulations as applicable to assigned duty stationCreate and adhere to a data quality and quality assurance planAssist with interim and annual reports. Complete required and applicable research training needed to complete researchMaintain and update files of all applicable regulatory documentation to IRB (including protocols, approvals, amendments, modifications, etc.)
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Clinical Research Coordinator
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May 2006 - Present
The Clinical Research Coordinator (CRC) comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal and hospital regulations. Depending on departmental organization, the CRC may also have responsibility for budget negotiation, monthly invoicing, account management, and regulatory paperwork. CRCs also give potential sponsors a "first impression" of the University of Utah, including the ability of the University to recruit and retain research subjects.Some responsibilities of the Clinical Research Coordinator (CRC), depending on the wishes of the PI, include:•Submitting regulatory documents to IRB and Sponsor•Submitting the clinical study agreement to OSP for review•Attending investigator meeting(s)•Developing a preliminary budget and verify all costs•Helping PI negotiate the study budget direct costs with sponsor to cover all costs (F&A costs are not negotiable)•Preparing for study initiation•Obtaining physician signatures•Recruiting subjects•Screening and scheduling subjects•Getting voluntary subject consent•Teaching subjects about protocol expectations for them•Performing study/protocol procedures in a detailed, accurate manner•Maintaining study files•Tracking and maintaining the study budget and payments, including invoicing the sponsor for completed work•Tracking subjects, avoiding lost-to-follow-up•Documenting an adverse event, including:◦describing the event◦severity and frequency◦treatment◦resolution•Processing and shipping lab work•Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel, including:◦IRB◦Office of Sponsored Projects◦Research AccountingHospital's Patient Accounting Office•Completing case report forms (CRA) for PI review and approval•Helping study monitors with CRA corrections
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Admitting Coordinator
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Sep 2003 - May 2006
The Clinical Research Coordinator (CRC) comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal and hospital regulations. Depending on departmental organization, the CRC may also have responsibility for budget negotiation, monthly invoicing, account management, and regulatory paperwork. CRCs also give potential sponsors a "first impression" of the University of Utah, including the ability of the University to recruit and retain research subjects.Some responsibilities of the Clinical Research Coordinator (CRC), depending on the wishes of the PI, include:Submitting regulatory documents to IRB and Sponsorsubmitting the clinical study agreement to OSP for reviewattending investigator meeting(s)Developing a preliminary budget and verify all costs•Helping PI negotiate the study budget direct costs with sponsor tPreparing for study initiation•Obtaining physician signatures•Screening and scheduling subjects•Getting voluntary subject consent•Teaching subjects about protocol expectations for them•Performing study/protocol procedures in a detailed, accurate mannerMaintaining study files•Tracking and maintaining the study budget and payments, including invoicing the sponsor for completed work•Tracking subjects, avoiding lost-to-follow-up•Documenting an adverse event, including:◦describing the event◦severity and frequency◦treatment◦resolution•Processing and shipping lab work•Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel, including:◦IRB◦Office of Sponsored Projects◦Research Accounting◦University Hospital's Patient Accounting Office◦ARUP LaboratoriesCompleting case report forms (CRA) for PI review and approval
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Education
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2000 - 2002
Advance College Business Management / Accounting
Business Administration and Management, General -
1987 - 1988
Larson Training Center
Business, Management, Marketing, and Related Support Services -
1982 - 1984
Cerritos College
Associate of Arts (AA) -
1978 - 1982
Excelsior High School
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2004 -
California Real Estate Studies
California Real Estate License
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