Office Manager Clinical Trial

JENNE ROSTEK

Pennington, NJ

***********@*****.***

Mobile 732-***-****

Professional Summary

Office Manager - Speech Academy LLC - January 2023 - April 2024

● Oversee and execute diverse human resource plans and protocols for all company personnel; collaborate with senior

management on developing and implementing personnel policies and procedures

● Facilitate communication with employees regarding payroll, benefits, and updates to HR policies as needed

● Manage the onboarding process for new hires, including payroll and coordination with IT for seamless employee

integration

● Handle terminations of employees•Support recruitment efforts by sourcing and screening candidates

● Manage employee relations, maintain company organization charts, and update the employee directory

● Ensure compliance with federal and state employment regulations

● Demonstrate understanding of basic accounting and finance principles, coordinating outsourced activities

● Proficient in data collection, assembly, and presentation for meaningful analysis

● Identify gaps and propose new approaches, policies, and procedures to enhance efficiency continually

● Negotiate procurement of office supplies, furniture, equipment, etc., adhering to company purchasing policies and

budget constraints

Johnson & Johnson - Clinical Trial Assistant (Contract) January 2010 - December 2016

● Collaborate with Study Teams to develop and facilitate approval of Registry and Reporting content

● Assist with results reporting to global databases as required (eg, CT.GOV, and ROW National Registries)

● Enters and releases the initial protocol information and revised protocol information on clinicaltrials.gov and

other websites as required by international law/guidance Policy

● Consults with relevant team functions to assimilate the required results data fields for posting. Ensures information is

entered in appropriate databases and reviews information for accuracy. Releases information to the public and responds

to government agencies to resolve issues if needed.

● Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies

● Archives registration and results posting documentation

● Communicates registrations and results dates and links to relevant stakeholders

● Updates existing registries with changes in ongoing clinical trial status including recruitment status, protocol

amendments, site updates and actual dates

● Monitors and tracks existing clinical trial registrations for future results posting and notifies appropriate team members of

upcoming deadlines

JENNE ROSTEK

Clinical Research Associate

● Assist with editing and reviewing clinical trial documents, including protocol, sample ICF or operations manuals

● Site management of clinical sites including, site training, protocol adherence, general correspondence

● Performs pre-study evaluation and site initiation visits to ensure compliance with the study protocol

● Develops/reviews visit reports on completeness and accuracy, and monitors clinical sites

● Assures correct shipping, storage, inventory and reconciliation; both in-house and at site of investigational product,

● Responsible for quality check of communication of essential regulatory documents

● Coordinate tracking and payment of grant-in-aid funds

● Review and analyze data reports for content and assimilates comments to internal team and/or vendor

● Perform GCP audit of Trail Master Files (TMF) for 3 Phase III international studies

● Reconcile file content versus required content

● Provide summary of discrepancies found in TMF; create / maintain database; track outstanding

documents, present status updates to clinical team during weekly team meeting, work with Clinical Operations, Monitors,

and Investigators to collect and track essential documents Roche Inc. - Clinical Operations Associate (Contract, Cost Management Incentives) December 2008 – May 2009

● Coordinate activities for LSIT with central laboratories, randomization organizations, and other courier companies,

Oversee the management of tracking systems for LSIT related to drug supply and use, enrollment of subjects, regulatory

document flow, study timelines, financial information, Serious Adverse Events, AIMS, data flow, Assist in the management

of US central labs for LSIT related to budget/contract specifications and negotiations, quality assurance, and invoice

review and payments.

● Assist in the management of US CROs related to budget/contract specifications and negotiations, performance related

to defined scope of work, timelines and quality, adherence to study criteria, invoice review and payment reconciliation

● Review monitoring reports to identify trends/issues within the US requiring local intervention

● Manage local drug ordering, shipping, retest/expiry, destruction/return and tracking

● Manage data flow process in conjunction to data review, query resolution and CRF collection and retrieval

● Monitor and track SAEs for the U.S.

● Manage the processing of SAE information received from investigators including review, clarification, and interactions

with monitors, sites, Drug Safety, and Clinical Science

● Assist with US study budget reconciliation and forecasting using standard planning and tracking tools

● Review audit plans and reports and assist in resolution of US issues identified by PDQ

(Quality Assurance)

JENNE ROSTEK

Forest Research Institute - Clinical Research Scientist- Gastroenterology (Contract, Clinical Dynamic) January 2008 – December 2008

● Work closely with investigative sites during the regulatory document process from start-up through closeout phases,

Implements and conducts study planning, execution, and assists in monitoring and completion activities

● Work closely with other departments to ensure the overall study timelines are met

● Assists the Regulatory Documents Coordinator with developing and maintaining databases for tracking of regulatory

documents, work flow process and other essential trial related documents

● Conduct study set-up activities - including the development of documents used during the study (such as Delegation of

Authority log, Investigator Study Binder, Source Document Worksheets, Drug/Device Accountability Logs, etc.).

● Review Confidentiality Disclosure Agreements and Clinical Trial Agreements

● Assist in the design of the Informed Consent template; Review protocol and assist and approve CRF design

● Organization and preparation of trial related material and presentations for Investigator meetings.

● Present as necessary at Investigator and Coordinator Meetings

● Assist in the training of investigative sites on protocol and procedures

● Work with Senior CRA and Sponsor in identifying and screening qualifications of appropriate investigative site

● Assist in the maintenance of a site/investigator selection system/process

● Provides centralized investigative site support, communication and coordination to assure accurate and timely

completion of all contracted activities

● Ensures that the project team assigned to the study meets all deadlines; maintains a close effectual relationship with

Sponsors, Research Coordinators, Principal Investigators, and designated regional CRAs

● Assist with managing all "in-house" site related activities, including Monitoring report review. Maintain communications

on a regular basis with the investigator and/or his/her assigned contact Daiichi Sankyo - Clinical Research Associate (Contract, Clinical Dynamic) January 2007 – June 2007

● Track study metrics, monitor Case Report Forms (CRFs) and study-related documentation, and assist with the

preparation of clinical trial protocols, clinical study reports, Investigator Brochures and Investigational New Drug (IND) and

New Drug Application (NDA) submissions

● Participate in Investigator's Meeting preparation and conduct

● Develop CRF completion guidelines, subject questionnaires, and maintain study timelines

● Ensure that study material; study-specific equipment, central labs, ethics committee/ regulatory approval, confidentiality

agreements, and other required documentation allow for initiation of the investigational trial

● Coordinate with the clinical supplies department to ensure proper distribution of investigational drug supplies. Liaise with

vendors (e.g. central laboratory, drug supply, data management, and CRO) to ensure that investigational trials are

conducted according to project timelines and objectives

● Management and track study budget and payments to investigators and contract groups

● Collaborate with data management to ensure the timely entry of CRF data, resolution of data queries

● Verify that Data Discrepancy Forms are filed and paginated correctly JENNE ROSTEK

● Document missing data and discrepancies for tracking in database and project plan, reconcile missing TMF documents

by performing a QC of all site files and country files for completeness and accuracy; generating request form to clinical

sites and field monitors to retrieve documents, prepare transmittal forms for submission to Clinical Documentation, meet

with clinical team weekly to discuss findings/progress

● Sign-off on complete CRFs for filing in Clinical Documentation

● Review scanned, book-marked CRFs to ensure links are accurate and documents are legible

● Conduct site initiation and monitoring visits

● Perform study close out and prepare reports related to study Johnson & Johnson (Kelly Scientific) - Medical Research Associate - Endovascular February 2006 – November 2006

● Protocol and CRF review, assist with site selection, work with legal department and site to finalize CA’s (Confidentiality

Agreement) and contract negotiation

● Interacts directly with investigators and/or other study site personnel regarding document updates or corrections, and

other routine business needs during the course of the trial, maintain timelines, develop study manuals, manage drug

accountability, CRO management

● Create & manage trial tracking spreadsheets and databases, Regulatory documents review: Study Survey, CV, Medical

Licenses, SOI (Statement of Investigator), and Legal Agreements and ensure document accuracy

● Monitor and maintain study-related materials are adequately supplied at the sites; ensure all unused trial related

supplies and materials are returned to the company or destroyed

● Review trip reports and provide feedback to the clinical team in a timely manner

● Perform co-monitoring to review accuracy of source documents, ensure site maintains license and certifications, and

resolve CRF discrepancies

● Perform GCP audit of trail master files (TMF) for 3 Phase III international studies to include, but not limited to: Reconcile

file content versus required content, Provide summary of discrepancies found in TMF, Work with Associate Director,

Clinical Operations to collect and track outstanding essential Key Interface include: Regulatory, Legal, HCC (Health Care

Compliance), and Marketing

Clinical Project Lead

● Project Lead: setting-up and maintaining Clinical Trial Master Files (TMF) as per SOPs and trial specific instructions

● Create workflow and assign tasks accordingly. Initiated an Internal guideline to perform Internal Audit of TMFs

● Construct and maintain a tracking database to monitor incoming documents from Clinical Affairs and the CRO

● Contact sites and/or monitors to retrieve missing documents

● Log queries and participate in QC review and report findings to assure accuracy JENNE ROSTEK

Altana Pharma - Clinical Trial Associate (Contract, Clinical Resource Network) March 2005 – February 2006

● Review adverse event forms from the site

● Alert database managers to any updated or corrected information obtained in subsequent reports, including follow-up

confirmation of updates, maintain a cumulative computer listing of adverse events

● Responsible for review of regulatory documents, which includes; 1572 forms, Financial Disclosures and Informed

Consents Forms and ensure document accuracy

● Create and maintain trip reports, follow-up letters and telephone contacts for assigned investigative sites

● Review CRFs for submission to clients & sponsors

● Devise and maintain project specific North American Medical Services master files

● Interacts directly with investigators and/or other study site personnel regarding document updates,

corrections, and other routine business needs during the course of the trial

● Manages trial tracking spreadsheets and databases, including document tracking, clinical and non-clinical supplies

tracking (ex: case report forms) and CRA management logs. (Pulmonary-COPD) Aventis Pharmaceuticals - Clinical Coordinator- Cardiovascular (Adecco) September 2000 - July 2003

● Accurately entered and verified clinical data from source document into clinical study database, performed quality

control (QC) checks against database to ensure correct data was entered and performed various checks

● Issued Case Report Forms to trial sites and scanned documents

● Review/maintained database for SAEs, and queried research sites to correct discrepancies found in Case Report Forms

● Maintain and track common area files; safety letters and IB’s

● Provide status updates for department meeting, Maintain data in CTMS and other tracking

systems/spreadsheets, assist with archiving activities

● Coordinator- Oncology (Contract Adecco)

● Researched company/vendor relations for future projects, as well as created and launched promotional ideas,

generated departmental monthly reports

● Completed monthly budget and expense reports; process invoices for payment and monitor budget

expenditures

● Created presentations, and coordinated staff & committee meetings

● Organized video & teleconferences, travel arrangements, advanced web research, maintained office

Education

Phoenix University 2017

Mercer County College 2024 (current)

Technical Skills

Microsoft Word: Word, Excel, PowerPoint, Access, Outlook; Visual Basic, FrontPage, FoxPro, IMPACT, Documentum 4.0,

AESOP, EasyTrak, Consumer Link, Adobe Acrobat, Oracle Clinical (4.0), Clintrial, InfoLInk 2, MedDRA and web design

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