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Clinical Team Lead Resume
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| Desired Industry: Biotech |
SpiderID: 17450 |
| Desired Job Location: Waynesboro, Virginia |
Date Posted: 12/3/2007 |
| Type of Position: Full-Time Permanent |
Availability Date: 12/3/07 |
| Desired Wage: 70k |
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U.S. Work Authorization: Yes |
| Job Level: Experienced with over 2 years experience |
Willing to Travel: Yes, Less Than 25% |
| Highest Degree Attained: Bachelors |
Willing to Relocate: No |
Objective:
To continue my career in Clinical Research with an
ultimate goal of Project Management/Clinical Study
Management within a CRO or Pharmaceutical
Company.
Experience:
PRA International
Charlottesville, VA
Clinical Team Lead
August 2006-September 2007
Manages investigational sites to ensure
compliance with the trial protocol, ICH-GCP and
applicable regulations
o Interacts with other project team members to
ensure site management outcomes are achieved as
required
o Reviews Essential Documents to ensure
sponsor and investigator obligations are being met
and are in compliance with applicable local
regulatory requirements and ICH guidelines
o Responsible for participating in Investigator
meetings and assisting with presentations as
required
Addresses and resolves all internal and
external clinical issues for client research projects
o Liaises with CRAs regarding site monitoring
issues providing recommendations and suggestions
for issue resolution
o Creates and maintains clinical project
documents, including Clinical Management Plans
Monitoring Guidelines, Site Operations Manuals and
Monitoring Visit Letter templates, other CTMS
activity templates, Monitoring visit
presentations/scripts as appropriate
o Provides data for clinical operations
performance and project status metrics as needed
o Identifies out of scope tasks from site
management team and escalates to the project
manager or Global Project Manager
o Liaises with Clinical Operations Managers to
resolve resource and performance issues
Leads the clinical team on a project, providing
training and monitoring as required
o Determines and tracks projected hours for
CRA/COS and Clinical Team Lead activities ensuring
adherence to contract and budget
o Assists with review of monitoring and trip
reports
TEG of Virginia, LLC
Charlottesville, VA
Research Associate IV/Project Management
June 2006-August 2006
Supervision of clinical projects; providing
leadership in the delivery of services to clients;
ensuring projects are delivered on time, within
budget, and in accordance with project proposal,
company policies, procedures, and SOPs
Responsible for project planning and
scheduling, data analysis plans, data management
planning, troubleshooting, and providing assistance
to all analysts on the team
Reported project status to clients and internal
management on a weekly basis
Analyzed, evaluated, and reported all clinical
data
Developed and disseminated results reporting
through various media types
Contributed to clinical publications, protocols,
manuscripts, and study proposals
Created study assessment tools in order to
obtain the appropriate data requested by the
sponsor
INC Research, Inc.
Charlottesville, VA
Project Research Associate
November 2005-June 2006
Participated in strategy meetings providing
process proposals and feedback on implementing
improvement procedures
Acted as the communications liaison for
multiple study sites, vendors, and sponsors
Provided direct support to Project
Management, Lead CRAs and Sponsors ensuring
that all study initiatives are met in a timely manner
Attended study team meetings along with
Investigator Meetings providing study status
feedback and updates as needed
Managed study sites for multiple studies in
order to retrieve outstanding Case Report Forms,
resolve queries and maintain the sites essential
regulatory documentation
Managed IRB status for study sites ensuring
that the site maintains the appropriate
communication regarding their site status
Reviewed, Revised, and provided feedback on
essential study documentation including
Communications Plans, Project Management Plans,
Essential Document Review Guidelines, and Clinical
Monitoring Plans
Performed Trial Master File audits and
reconciliation in order to ensure that all files were
being housed according to the ICH/GCP Guidelines
and acted as a reference point for how processes
could be improved for efficiency moving forward
PRA International
Charlottesville, VA
Clinical Operations Specialist III
May 2005-November 2005
Clinical Operations Specialist II
August 2003-May 2005
Clinical Operations Specialist I
May 2002-August 2003
Performed as the Lead COS on multiple studies
providing support for the randomization of
patients, answering protocol questions, and
ensuring that the sites maintain IRB, PRA, and
Sponsor Approval
Composed Site Support Specifications for
studies in start-up
Presented the LCOS project plan for multiple
Sponsor Kick-off meetings
IRB submissions for site regulatory and all new
or updated documentation
Electronic regulatory submissions uploading
documents into sponsor-specific databases
Provided weekly deliverable reports to Lead
CRA and Project Manager including subject
enrollment, IRB status, and monitor visits
Responsible for maintaining study databases in
order to track all recruitment and active study
information including subject enrollment, site
status, site visit, site information, protocol
deviations, etc.
Managed multiple sites in-house in order to
maintain consistent correspondence with
investigative sites in order to retrieve outstanding
regulatory documentation, tracking the status, and
providing weekly status reports
Performed investigative site file reconciliation;
requested any new or updated site-related
essential and non-essential documents and
reviewed them for content, consistency with other
documents, and compliance with appropriate local
regulatory requirements, ICH guidelines, project
Standard Operating Procedures (SOPs), and sponsor
requirements
Trial Master File preparation for internal and
external audits including intensive file review to
ensure that the TMF files are accurate and current
Coordinated and participated in the end of
study TMF Reconciliation to ensure the review
completion of files prior to study close out after
first conducting an internal file audit
Tracked, reported, and followed up for all TMF
reconciliation findings
Query resolution and retrieving missing CRF
pages to ensure that all patient data is collected
prior to all data transfers and database lock for all
desired data
Documented and filed all site, client, and
vendor correspondence and study interactions
Provided projected hours, metrics, and
requested reports to Project Managers, Lead CRA,
and Functional Manager
THERAPEUTIC EXPERIENCE
Oncology
CNS
Colorectal
Diabetes/Tight Glycemic Control (TGC)
Dermatology
Device
Education:
B.A. Communications and Public Relations, May, 2001
George Mason University, Fairfax, VA
Affiliations:
Member of the Project Management Institute and
eligible to take the CAPM (Certified Associate of
Project Management) exam.
Skills:
Thorough knowledge of ICH-GCP guidelines
Strong background in training and mentoring
other employees
Solid customer service skills including
marketing and advertising.
Ability to work independently as well as in a
team-oriented environment.
Exceptional learning potential and ability to
multi-task.
Flexibility to travel.
Ability to learn at an advanced rate in addition
to being detail-oriented.
Clinical Research experience in Phase I-IV
studies
Additional Information:
PRESENTATIONS
Investigator Meeting Presentation for
investigational product handling and administration
Client presentations to discuss project plans
for multiple Sponsor and Internal Kick-off
meetings.
Participated in a Panel Discussion to answer
job-related, functional, and departmental questions
from employees in different departments in 2004.
Conducted a training session in July of 2003 on
Management of Essential Documents.
Reference:
Available upon request
Candidate Contact Information:
This candidate has chosen not to make contact information available on this page.
Click "Contact Candidate" to send this candidate a response. |
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