Senior Clinical Research Associate

Rose Ann R. Vandetty Page - *

ROSE ANN R. VANDETTY

*** ***** ******

Collegeville, PA 19426

Cell: 610-***-****

e-mail: *******@*****.***

Profile

Senior Clinical Research Associate with extensive expertise in global registration and post-

marketing development programs. Results-oriented individual who is highly focused on internal

and external customer satisfaction, timely issue resolution, and integrated team process. Strong

team member recognized for excellent communication, collaboration, and mentoring skills.

Site Monitoring/Data Evaluation Serious Adverse Event Analytical and Tactical

(document and track) Thinking

Plan/Manage Clinical Trials Medical Device CRO/Vendor Oversight

Dermatology/Musculoskeletal Recruitment/Feasibility Site Management/Relations

Infectious Disease/In Vitro CNS/Chronic Pain/Oncology Early Phase

Fertilization (IVF) Phase II/III

Phase IV

PROFESSIONAL EXPERIENCE

Sr. Clinical Research Associate 12/15/2014-Present

Accelovance, Inc. Home-based

• Participate in identification of potential investigators and clinical sites, conduct pre-study

site visits, collect/review site documents, prepare site qualification reports and associated

documentation, participate in final selection of investigators and study sites.

• Assist with development and implementation of study-specific monitoring/reporting

procedures, methods, guidelines and tools; participate in development of subject tracking

systems.

• Conduct site initiation visits, train site personnel on sponsor and regulatory requirements

for study conduct; participate in site meetings and multicenter investigator meetings;

prepare site initiation visit reports.

• Conduct site monitoring visits and follow-up to identify significant problems and issues and

ensure that all clinical aspects of studies are being carried out in accordance with study

plans, GCPs, and applicable regulations; prepare monitoring visit reports.

• Review on-site files and records, Case Report Forms, and source documents for

completeness, accuracy, consistency, and compliance; identify deficiencies and

discrepancies; initiate corrective action as required; ensure training is provided within a

reasonable timeframe, is current, and is documented appropriately.

• Ensure appropriate transmission of clinical data management centers; review data

queries, clarify and/or obtain changes to data as appropriate.

• Assist in close-out of clinical studies by identifying items and issues for review and/or

follow-up; assemble necessary documents, conduct site close-out visits to include

Investigational Product reconciliation and disposition, review of completeness and

accuracy of files, and retrieval of relevant codes and documents; prepare site close-out

reports and associated documentation.

• Attend team meetings as required.

Study Assignments:

In Vitro Fertilization

Responsibilities:

• Countries: US and Canada

• Study Stage: Phase III

Clinical Research Associate 7/2013-7/2014

Jazz Pharmaceuticals, Inc. Philadelphia, PA

• Assisted with managing CRO and vendors

• Assisted with investigator selection

• Prepared study documents such as the Monitoring Manual, Study Operations Manual,

Source Data Verification Plan and Laboratory Manual

• Coordinated and was responsible for the design of study materials such as CRFs, patient

diaries, study participation cards and source documents

• Assisted with protocol development and study report completion

• Performed monitoring activities at clinical study sites to assure adherence to Good Clinical

Practices (GCPs), SOPs and study protocols

• Tracked patient enrollment; qualified, initiated, monitored, performed closeout activities;

and assisted in coordination of data management activities

• Co-monitored with contract research organizations and reviewed site monitoring reports

• Coordinated study supplies

• Reviewed Informed Consent Forms, CRFs, and study related materials

• Planned and participated in investigator meetings

• Assisted and supported data query process

• Assured regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs,

FDA regulations, and ICH guidelines

• Reported PSUR and annual reports; tracked and reported clinical trial information and

progress regarding patient recruitment, screening, monitoring, clinical and laboratory

(PK/PD/ADA) data, data cleaning status for assigned clinical study.

• Ensured trial master file was current and maintained.

Study Assignments:

Severe Chronic Pain

Responsibilities:

• Countries: US and Canada

Rose Ann R. Vandetty Page - 3

• Study Stage: Observational Study (Registry)

• Infusion pump

Narcolepsy Study

Responsibilities:

• Countries: US

• Study Stage: Phase I

Oncology - Non-Hodgkin’s Lymphoma – Pediatric Oncology Study

Responsibilities:

• Countries handled: US and Canada

• Study Stage Handled: Phase III

Clinical Research Associate 1/2012-7/2013

ICON Clinical Research North Wales, PA

• Identified, selected, initiated, and closed-out investigational sites for clinical studies.

• Monitored sites in order to ensure that studies were carried out according to the study

protocol, ICON SOPs, applicable regulations and the principles of ICH-GCP.

• Maintained timelines, assisted in preparation of regulatory submissions; design of patient

information sheets and consent forms; ensured timely submission of protocol/consent

documents/safety reports for Ethics/IRB approval, according to local requirements; pre-

study, placement and initiation visits;

• Conducted regular monitoring visits in accordance with Company site-monitoring

SOP/Sponsor site monitoring SOP.

• Assisted in other areas of study management and staff training, and contributed to the

review of ICON systems and procedures as appropriate; provided a benchmark of

monitoring competence to inexperienced/less experienced colleagues.

Study Assignments:

CNS - Major Depressive Disorder - Pediatric Study

Responsibilities:

• Countries handled: USA

• Study Stage Handled: Phase III

Dermatology – Psoriasis

Responsibilities:

• Countries handled: USA

• Study Stage Handled: Phase III

Clinical Trial Assistant 12/2011-1/2012

ICON Clinical Research North Wales, PA

• Provided general administrative support to the Clinical Operations Department and

assistance to Project Manager(s) and Project Director(s);

• Assisted the Clinical Operations team in the completion of all required tasks to meet

departmental and project goals;

• Supported the Clinical Operations team with the ongoing conduct of studies;

• Followed appropriate regulations, relevant ICON SOPs and internal tracking systems;

• Became familiar with role of CRA, including site visits; set up, organized, maintained

clinical study documentation (i.e. Main Study Files, CRFs, etc.), including preparation for

internal/external audits, final reconciliation and archival; processed Data Collection Forms,

i.e. Log In, Tracking, Quality Control;

• Coordinated ordering/dispatch and tracking of trial materials (i.e. CRFs, diary cards, lab

and drug supplies);

• Assisted project teams with trial progress tracking by updating Clinical Trial Management

systems.

• Copied and routed incoming correspondence, internal documentation, CRFs, etc.;

• Contacted sites for specific requests (enrollment updated, missing documentation,

meeting arrangements);

• Assisted in tracking and distribution of safety reports; assisted in coordination of

Investigator Meetings.

Study Assignments:

Oncology - Positive Acute Lymphoblastic Leukemia (ALL)

Responsibilities:

• Countries handled: US; EX-US

• Study stage handled: Study Transfer to Alliance Partner

Senior Site Relations Manager (Contract) 9/2011-11/2011

Medici Global King of Prussia, PA

• Managed all study site interactions for each of the assigned projects.

• Established relationships and maintained on-going communication with

research sites throughout the project.

• Assisted in referral processing and the pull-through process.

• Identified barriers at the site level that were impacting recruitment/retention.

• Collaborated with internal teams to ensure study success.

• Project Set Up - Facilitated initial contact (email, phone or survey) with the sites at the start

of every study and documented all pertinent information; collected specific details about

study site and communicated to project team.

• Performance Tracking of Study Sites - Analyzed site metrics on a weekly basis, evaluated

site performance and communicated which sites should continue to receive advertising

support and which should be placed on hold; notified Project Team and eMarketing.

• Site Relations - Identified responsible study staff handling the patient recruitment and/or

retention efforts at the study sites; built relationships with sponsors, sites, CROs and

CRAs; served as the primary contact for study coordinators on assigned

recruitment/retention projects; participated in client and CRO calls/meetings.

Study Assignments:

Musculoskeletal/Arthritis - Gout Study

• Countries handled: US and Canada; Australia/New Zealand (90 sites)

• Study stage handled: Phase IV

Clinical Trial Assistant/Executive Administrator 6/2007-3/2011

Pfizer Inc. (formerly Wyeth Pharmaceuticals) Collegeville, PA

• Support for the planning, implementation, and management of multiple Phase IV lifecycle

clinical trials.

• Facilitated activities across three large global clinical trials to ensure consistency of trial

Rose Ann R. Vandetty Page - 5

design, medical review, and statistical data analysis in complicated skin and skin structure

and complicated intra-abdominal infection indications. Chaired bi-weekly integrated team

meetings to discuss study status, share and resolve issues, and anticipate potential

roadblocks to meeting timelines.

• Communicated and resolved issues not requiring medical judgment with other internal

team members; facilitated contract issues with CROs, Vendors, Legal and Central

Contracting groups.

• Assisted in distribution of IND Safety Letters to investigators.

• Facilitated processing of time-sensitive documents, gathering authorizations for labeling,

safety, publications, legal, promotional materials or finance.

• Expedited labeling documents for review and approval through all arteries, such as

Medical, Marketing, Regulatory, etc., and distributed amended versions.

• Diplomatically navigated through executive management to expedite reviews and

approvals.

• Communicated sensitive issues, exercising judgment and discretion.

• Prepared travel itineraries, agendas, reports and presentations.

• Composed routine communication; distributed and/or responded to routine

correspondence.

• Documented incoming serious adverse events, delivered to clinician for classification and

then to medical monitor for approval signature. Follow-up by forwarding to Safety US and

EURO, also documented.

• Conducted literature searches and ordered relevant articles.

Clinical Trial Assistant/Senior Administrator 2/2001 – 5/2007

Wyeth Pharmaceuticals Collegeville, PA

• Supported Infectious Disease Team during the oversight of a large North American Phase

IV complicated intra-abdominal infection study consisting of 50+ investigator sites which

resulted in a number of supportive scientific publications to grow the franchise.

• Supported a variety of smaller studies for publication and bioequivalence testing studies

for other Wyeth anti-infective products.

• Ensured the successful and timely completion of all aspects related to Phase IV studies as

assigned.

• Drafted clinical study agreements, composed correspondence, scheduled interviews.

• Prepared investigator grants payment requests and corresponding cover letters for

distribution to company Finance and Clinical Investigators.

• Maintained clinical grant tracking database for each study, generated periodic reports on

status of grant payments and resolved payment inquiries from investigator sites.

• Collaborated with U.S. and Global Marketing in joint meeting planning, training scheduling.

Clinical Trial Assistant/Senior Administrator 6/2000 – 1/2001

Wyeth Pharmaceuticals Collegeville, PA

• Created and maintained central files for regulatory documents required for clinical trials,

(FDA Form 1572, CVs, Financial Disclosure, Lab Certifications)

• Assisted Clinical Research Manager in preparing and tracking investigational product

supplies, packaging and shipment requests and circulating these requests for appropriate

approval.

• Collaborated with Cardiovascular Marketing personnel for meeting/travel planning for

investigator meetings, advisory board meetings, point of action meetings and training

seminars.

• Maintained and updated clinical investigator and study data in IMPACT (International

Management Package for Administration of Clinical Trials)

• Assisted with training program planning for salespeople and medical science liaisons in

launch of cardiovascular drug.

• Supported Senior Director, Director and Market Research Manager of Cardiovascular

Therapeutic Area by planning meetings, training and travel.

EDUCATION

Bachelor of Business Administration August 2007

American Intercontinental University Hoffman Estates, IL

• Concentration in Healthcare Management

• GPA: 3.70 Magna Cum Laude

Associate of Arts in Business Administration July 2006

American Intercontinental University Hoffman Estates, IL

• GPA: 3.79 Honors

SOCRA

• Clinical Science Course for Clinical Research Professionals July 2011

35 CE Credits

TECHNICAL SKILLS

ARIBA MS Office

CONCUR MS Outlook

Documentum OC-RDC

ELARA Peoplesoft

eTMF Planview

Groupwise Power2Learn

GTS (Grant Tracking System) RighTrackII

ICOTrial SAP

IMPACT Sharepoint

IMPALA Medidata (RAVE)

Medrio

PROFESSIONAL MEMBERSHIPS

• Society of Clinical Research Associates (SoCRA) 2007-Present.

• Association of Clinical Research Professionals (ACRP) 2010-Present.

Contact this candidate