Project Clinical Research
Resume:
Jacqueline Ellis, B. Sci. Biology, cum laude
Durham, NC
**********.**********@*****.***
CAREER HIGHLIGHTS
A Clinical Research Associate with over 18 years of North American and Global clinical research monitoring experience within the CRO environments. Key therapeutic areas include: solid and liquid tumor oncology and hematology. Performed site feasibility, site selection/ initiation/ monitoring/ close-out visits to ensure delivery within contractual obligations. Reviewed trip reports, approved expense reports, provided CRA training and mentoring, conducted CRA performance evaluation visits, query and data management, study metrics tracking, development of project management and monitor plans.
THERAPEUTIC EXPERIENCE
Oncology/Hematology Infectious Disease/Respiratory
Breast, 8 trials – Phase I- III CAP, 1 trial - Phase III
NSCLC, 10 trials – Phase I-III Bronchitis, 1 trial - Phase III
Colon, 2 trials – Phase III Sinusitis, 1 trial - Phase III
Ovarian, 3 trials – Phase II
Lymphoma, 2 trials – Phase II Pancreatic, 1 trial –Early Phase II
Gastric/GE Junction, 1 trial –Phase II
Hepatocellular, 1 trial – Phase II
SCLC, 2 trial – Phase I
AML, 2 trials, Phase I
MDS, 1 trial, Phase I
CNS Various
Schizophrenia Phase II, 1 study Hypertension, 1 trial - Phase III
Chemotherapy-Induced Emesis, 1 study Ulcerative Colitis: 2 trials – Phase I
EDUCATION
Bachelor of Science, cum laude, May, 1993
North Carolina State University, Raleigh, North Carolina
EMPLOYMENT
INC Research
Regional and National: Durham NC
Home-based Senior Clinical Research Associate
January 2015 – August 2016
Performed SSV, SIV, quality inspection and retraining, routine monitoring visits, COVs, SWAT visits, and Ad-hoc monitoring visits.
●Implemented applications, reports and document repositories
●Monitored clinical trials to ensure investigator compliance with applicable local regulatory requirements and ICH guidelines
●Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, review data and ensure data accuracy, and to terminate study sites (70% travel)
●Provided regular clinical status information to team members and project management, data and issue trends, followed escalation, corrective as warranted
●Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures (SOPs)
●Worked closely with team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff
●Performed investigative site file reconciliation: requested any new or updated site-related essential documents and reviewed them for content, consistency, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements
●Performed source document verification, electronic data capture verification, and remote data review
●Performed query resolution in a timely manner and drug accountability.
●Ensured Serious Adverse Events (SAEs) are reported according to project, ICH and GCP requirements
●Responded to clinical supply, query, and system access requests from investigative sites
PSI-CRO AG
Regional and National: Durham NC
Home-based Clinical Team Lead/Senior Clinical Research Associate
April 2014 – October 2014
●Performed trip report review, performance evaluation and sign off visits (35-40% travel), Perform expense report review
●Conducted regular data and monitoring metrics review
●Provided CRA training and mentoring
●Conducted weekly CRA team meetings
●Performed regular study metrics management
●Conducted study data management
●Participated in weekly and ad hoc client meetings
●Conducted monitoring visits with CRAs during data sweeps and as needed (35-40% travel)
●Created/Developed Clinical plans, manuals, and reference documents as needed.
Quintiles Transnational, Inc.
Regional and National: Durham NC
Home-based Senior Clinical Research Associate
April 2013- April 2014
●SE and Central Regional oncology monitoring
●Managed query and data management, study metrics tracking
●Performed SSV, SIV, routine monitoring visits, COVs, SWAT visits, and Ad hoc monitoring visits, high enroller principal monitoring
● Implemented applications, reports and document repositories
●Monitored clinical trials to ensure investigator compliance with applicable local regulatory requirements and ICH guidelines
●Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, review data and ensure data accuracy, and to terminate study sites (70% travel.)
●Provided regular clinical status information to team members and project management, data and issue trends, followed escalation, corrective as warranted.
●Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures (SOPs).
●Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff.
●Performed investigative site file reconciliation: requested any new or updated site-related essential documents and reviewed them for content, consistency, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements.
● Performed source document verification, electronic data capture verification, and remote data review.
●Performed query resolution in a timely manner and drug accountability.
●Ensured Serious Adverse Events (SAEs) are reported according to project, ICH and GCP requirements. Respond to clinical, supply, query, and system access requests from investigative sites.
On assignment with Pharm-Olam, Inc. via Novella, Inc.
Regional and National: Durham NC
Home-Based Contract Senior Clinical Research Associate
October 2012 – April 2013
Visited sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies (Travel 80%)
Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and were in compliance with applicable local regulatory requirements and ICH guidelines.
Provided regular clinical status information to team members and project management, escalated issues as warranted
Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures (SOPs)
Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff
Communicated common site trends to study management team
Performed investigative site file reconciliation; requests any new or updated site- related essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements
Performed source document verification and electronic remote data verification
Performed drug accountability and safety information reconciliation at investigative sites
Ensure Serious Adverse Event (SAE) reported according to project specifications.
Beardsworth Consulting Group, Inc.
Regional and National: Durham, North Carolina
Home-Based Contract Senior Clinical Research Associate
July 2012 to October 2012
Responsibilities included extensive involvement with site management & sponsor contact as follows:
Conducted SIV and IMVs for multiple study sites nationwide
Assessed sites to identify root problems and resolve them as needed
RPS, Inc.
Regional and National: Durham, North Carolina
Home-Based Senior Clinical Research Associate
April 2011-July 2012
Implemented and monitored clinical trials to ensure sponsor and investigator site compliance
Provided regular clinical status updates to project team, escalated issues as warranted
Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures (SOPs)
Worked closely with other team members to ensure timely resolution of project and/or clinical issues
Communicated common site trends to Clinical Operations and Project Managers
Performed investigative site file reconciliation; processed new or updated essential documents
Performed source document verification and electronic data verification.
Performed query resolution in a timely manner
Conducted complete investigational product accountability
Ensured Serious Adverse Event (SAE) were reported according to project specifications
Responded to supply and access requests from investigative sites in a timely manner
Mentored junior level CRAs and served as a training resource for new employees
PRA International
Regional: Durham, North Carolina
Home-Based Senior CRA
April 2003-March 2011
Conducted CRA performance evaluation visits and sign-off visits
Provided CRA project-specific training and mentoring
Performed routine monitoring visits, Ad-hoc monitoring visits, high enroller principal monitoring
Implemented and monitored clinical trials, ensured investigator compliance with applicable local regulatory requirements and ICH guidelines.
Visited sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, ensured data accuracy (90% travel)
Provided regular clinical status information to team members and project management, data and issue trends, followed escalation, corrective as warranted
Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures (SOPs)
Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff
Performed investigative site file reconciliation; requested any new or updated site- related essential documents and reviewed them for content, consistency, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements.
Performed source document verification, electronic data capture verification.
Performed query resolution in a timely manner and drug accountability.
Ensured Serious Adverse Events (SAEs) were reported according to project, ICH and GCP requirements
Responded to clinical supply and system access requests from investigative sites
Mentored junior level CRAs and served as a resource for new employees
PPD Development
Research Triangle Park, North Carolina
Senior Clinical Research Associate, permanent
January 2000- March 2003
Provided leadership and guidance for up to 35 CRAs on multiple global studies
Provided project-specific training, and skills development training for new hires
Conducted Monitoring Visit Evaluations and Sign-Off Visits per Study Management Plan (55-65% travel)
Reported metrics, backlog and issues weekly to Project Manager and as needed
Performed routine co-monitoring visits to high enroller sites, ad-hoc site visits, and data sweep monitoring visits (35-45% travel)
Contract Clinical Research Associate
August 1998 – January 2000
●Conducted pre-study, site initiation, regular interim, and closeout visits to assess sites’ compliance with protocol, Code of Federal Regulations, Good Clinical Practice, and pertinent SOPs; performed 100% review of source documentation against CRF documentation to determine accuracy and completeness of data submissions; wrote field correction forms as needed, and followed up with sites to ensure data omissions and or discrepancies were resolved in a timely manner; conducted site and investigator file audits; performed project-specific lead CRA tasks and training as defined by study project; completed job and role-specific ongoing training on time.
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