Clinical Research Professional - Biotech Resume Search
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Clinical Research Professional Resume


Desired Industry: Biotech SpiderID: 62441
Desired Job Location: Raleigh, North Carolina Date Posted: 7/20/2012
Type of Position: Full-Time Permanent Availability Date: 07/30/12
Desired Wage: 74000
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, 50-75%
Highest Degree Attained: Bachelors Willing to Relocate: No


Objective:
OVERVIEW:
Bachelor’s level research professional
with both regulatory and clinical
experience seeks challenging career in a
clinical research.

STRENGTHS and ABILITIES:
• Study Start Up, Project
Management, Clinical Trials Assistant
• Reviewing and reconciling
monitoring trip reports
• Write and review informed
consents for Clinical Studies and
Investigator sites
• Sending, Collecting, and
Reviewing of Regulatory Documents
• Negotiation of Investigator and
Vendor Contracts
• Reviewed, Maintained and
Prepared Trial Master File for FDA Audit
• Familiar with Regulatory
agencies both US & International studies
• Has a broad working knowledge of
the industry which allows the ability to
make sound decisions quickly


Experience:
2/2012 - Current Project Coordinator,
Novella Clinical Duties: Tracking,
measurement and evaluation of project
metrics to implement efficiencies,
Suggests recommendations for outliers
found in output, Works in conjunction
with Project Manager to formulate a
project specific training matrix,
Communicates with training department to
ensure matrix is uploaded into LMS,
Electronic distribution of expedited
safety reports, tracking the sent date
in CTMS and filing the project specific
email electronically in the Outlook site
public folder for the study as well as a
hard copy of the email is to be sent to
the Novella Clinical Central File Room,
Setting up projection meetings for their
Novella Clinical internal teams
attending the meetings in order to
provide their projected metrics for
Project Coordination billable hours
throughout the course of the trial,
Provides justifications for overages in
Project Coordination billable time,
Assists Project Manager with quarterly
project master file audit and formulates
recommendations for missing components,
Collaborates in the design, development,
and maintenance of CTMS, Participates in
user acceptance testing (UAT) Updates
CTMS operations guide with project
specific information Manages protocol
deviation tracking including client
evaluation and subsequent documentation.
Formulates recommendations to create
efficiencies, Develops methodology for
site training documentation and
interfaces with client, Develops project
specific working practices, Maintains
support responsibility, including
scheduling, managing agenda updates,and
meeting notes for Project Review
Meetings, post-study review meetings,
and other meetings, as assigned,
Participate and assist in the planning
and creation of client and investigator
meetings and related materials,
6/2011 - 12/2011 Clinical Trial
Specialist, PAREXEL International
through Anchor Technologies
Duties:Conduct and facilitate specific
start-up activities on a country level
with a high accountability on quality
and timelines site identification,
feasibilities SRP collection, review and
approval,ICF customization and approval,
EC and RA submissions, as well as
preparation and negotiation of Clinical
Site Agreements (CSAs) and budgets
8/2009 – 6/2011 Clinical Trial
Assistant, UCB through Accord Scientific
Duties: Assisted one or more clinical
trial team(s) to manage trials
efficiently and to the required
regulatory standards especially with
document management and tracking,
including setup and maintenance of Trial
Master Files. Provided assurance that
studies followed all relevant SOPs and
GCP.Created, maintained and updated
trial tracking tools/lists (e.g.
Clinical Trial Management System,
IMPACT) and trial budget spreadsheets.
Participated in the site selection
procedures by determining appropriate
sites, making contact with potential
sites, discussing the protocol(s),
sending out feasibility packets.
All regulatory documents; initial and
ongoing review and filing and all study
start up and maintenance activities.
Negotiation contracts and budgets when
the primary contact was not available.
Organization of investigator meetings:
selection of venue, team building
activities, creation of agenda, slides
and binders, regulatory document
presentation and investigator meeting
rehearsal ensuring every presentation
was updated and accurate to meet the
needs of the study. Investigator
payments and all study invoices.
Creation of study materials:regulatory
document binders study reference manuals
Sending out study supplies and pertinent
study information. Point of contact for
incoming site information: DCFs
transmittals, pass through invoices
Assisted with the maintenance of the
working relationships with the study
vendors, Assisted in the handover
training meeting to the CRO. Assisted
Project Manager:Review timelines and
forecast budget and study milestones.
Provide explanation of budget variances
Creation of MMP, Review of Vendor
Manuals and Specifications,
Participation in round table discussions
of the protocol in preparation of for
finalization, Participated in the,
Generation of purchase orders for study
needs Tracked all study cost:Monthly
accruals, Pass through cost,Reoccurring
vendor monthly cost, Investigator
Payments, Received and coded all study
invoices for payment,
9/2006 – 5/2009 Westat Research, Inc
Mentor – Duties:Provided weekly review
of performance with Data Collectors,
Creation and presentation of weekly
group training session,Provided
additional traing for Data Collector who
were in need of more guidance and
training to reach compliance,Tracking
and dealt with attendance issues and
timesheet issues,Performance of line HR
responsibilities: semi annual
performance reviews, dealing with
employee issues etc. Team Leader-
Duties:Monitor and provide feedback and
coaching tips to data collectors,
Assisted with and performed project
training for data collectors
8/2006 – 10/2007 Clinical Document
Specialist, Otsuka through Precept Life
Sciences Duties:Reviewed, organized, and
QC’ed paper and electronic clinical
trial documents, Audited clinical trial
master files and investigator files in
preparation for document scanning,
verify that all required documentation
is present in the clinical file, and
identify any missing documentation,
Reviewed, audited, and processed
clinical study documents in EPIC; and
ensure that the quality of the
electronic document is adequate and that
correct naming conventions are used.
Identified and tracked issues for
follow-up with the CRA(s), CRO, or study
site, as directed by the clinical
development manager for the therapeutic
area, Prepared materials for inclusion
in final study reports and other
regulatory submissions
11/2004 – 3/2006 Site Start Up
Specialist and Site Start Up Lead,
Quintiles Site Start Up Lead Duties:
Trained all associates, coordinators and
specialist assigned to the project,
Assignment of duties to the team
members, Maintained study start up
metrics,Provided reports to project
management and the sponsor on the
studies,Delivered the site start up
portion on time based off the
projections given by the sponsor.
Tracked IRB approvals, contracts and all
documentation required for site start-
up, Created a manual for team members
that contained all needed material for
the conduct of the study (Protocol,
Regulatory Document Templates,
Guidelines on review, FQA, contract
negotiation perimeters, ICF/Regulatory
Review Checklist). Creation of the local
sites ICF, the clinical trial agreement,
the budget template and all trackers to
be used by the site start up
coordinators. Assisted the Clinical Team
on scheduling SIVs and ensuring a smooth
transition from site start up.
Participated in the preparation of bid
defense for prospective client awards.
Provide feedback to the managers of the
site start up coordinators assigned to
my projects on their performance.
Responsible for at most three sites
study start up process on each of the
assigned studies on top of my duties as
lead. Site Start up Specialist Duties:
Collection and management of study
sites' Regulatory Document Approval
Process including 1572s, CVs, Financial
Disclosures and Contract submissions
Review of all regulatory documents for
submission to IRB and sponsor
Submission of IND reports to IRB and
sites. Negotiations of study
budgets/contracts. Mentored new site
start up associates and coordinators.
11/2003 – 11/2004 Clinical Study
Specialist, GSK Duites: Sent, collection
and management of study sites'
Regulatory Approval Process (Study Start
Up) including 1572s, CVs, Financial
Disclosures and Contract submissions
Reviewed of all regulatory documents for
submission to IRB Sending of CDAs and
regulatory packets to the potential
Investigators Mass mailings and faxes to
the sites Submission of IND reports to
IRB and sites, took and typed minutes
for team meetings Maintained tracking on
essential documents, Prepared site file
notebooks for shipment to the sites
Negotiations of study budgets/contracts
Created study tools, study reference
binders, retention and recruitment
items. Generation of investigator
payments, Creating retention/recruitment
kits, Point of contact for in-coming
site communications,Assisted the project
manager in managing global
communications, Documented Study Conduct
Team meetings, decisions, and other
required documentation, Assisted in site
selection and feasibility, Negotiated
contracts with vendors,Ordered all study
supplies, Managed the working
relationship with the vendors and
assisted in the monitoring of their
performance, Tracked all IRB approvals,
contracts, and all documentation
required for site start-up, Tracked and
assisted in analyzing patient enrollment
Tracked down study documents (revised
regulatory documents from the sites),
Assisted occasionally on monitoring
visits on the collection of regulatory
documents, Provided assurance that
studies followed all relevant SOPs and
GCP, Organized investigator meetings:
selection of venue,creation of agenda,
slides and binders,regulatory document
presentation and investigator meeting
rehearsal ensuring every presentation
was updated Assisted in the development
of the CRF
1/2003-6/2003 Research Assistant II, PPD
Development Duties:Collection and
management of study sites' Regulatory
Document Approval Process including
1572s, CVs, Financial Disclosures and
Contract submissions,Reviewed of all
regulatory documents for submission to
IRB and sponsor,Submission of IND
reports to IRB and sites, Maintained
tracking on essential documents,
Assisted with negotiations of study
budgets/contracts to complete the study
start up procedures.


Education:
EDUCATION:
University of North Carolina at Chapel
Hill – Biology


Skills:
THERAPEUTIC AREAS: Auto immune disease,
Cardiovascular, Oncology, Neurology,
Gastroenterology, Respiratory,
Infectious Disease, CNS and Hypertension

COMPUTER PROFICIENCIES:
• Microsoft Office, Excel, Word,
PowerPoint
• Outlook
• EDMC
• Impact
• InfoLink 1 and 2
• Site Descriptor
• SAP
• MS Project 98
• Lotus Notes


Additional Information:
AWARDS: Quintiles - Customer Care
Awards given for outstanding service
recognized by the client (received 5
awards). STAR Awards given for
teamwork, leadership, customer service,
loyalty, and integrity from internal
team members (received 8)


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