Jacqueline Ellis, B. Sci. Biology, cum laude

Durham, NC

acwoyl@r.postjobfree.com

919-***-****

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.

Contact this candidate