Clinical Research Project Management

LORA L. ROBERTSON

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

765-***-****(Cell)

SUMMARY OF QUALIFICATIONS

Results-driven management professional with over 20 years of experience in Clinical Research, Insurance, Medical Assisting and Quality Management. Well versed in ICH and GCP guidelines. Effective communicator possessing excellent interpersonal and relation-building skills, who has earned a reputation for outstanding people management and process management while delivering results that exceed organizational goals.

~I’m successful, because I enjoy people and processes

PROFESSIONAL EXPERIENCE

KEYWORDS STUDIO 2018 – 2024

Distribution @ Eli Lilly

Manager/Trainer

Product Transfer, productivity and efficiency management

Export Verification training

Resource Management, Task Metrics

BP, SOP creation and revision

Site specific shipping and shipment audits

INSURANCE SPECIALIST III

Black Insurance Billing Specialist 2014 - 2018

Medical billing, coding, credentialing

Accounts Receivable

Issue resolution

Authorizations specialist

COVANCE CENTRAL LABORATORIES 1998 -- 2013

Held several positions at Covance, including all aspects of Phase I – IV research. Roles held range from data administration, customer facing roles, project management, and clinical data management. Instrumental in the development of a new global department that managing referral lab data.

COVANCE CENTRAL LABS SERVICES – Data Manager 2010- 2013

Resolved data discrepancies with sites, internal departments and clients

Transferred customer files via interface

Manage client query issues and monitor site resolutions

Performed quality assurance activities for Data Management department ensuring adherence to GCP and SOPs.

Accomplishments:

Re-organized Sharepoint Database to a more user-friendly format

Facilitated Management Essentials Training for new managers

Identified and helped implement an automated solution to clinical data files delivery

COVANCE CENTRAL LABS SERVICES 2008 - 2010

Project Management

Monitored lab flow and customer team results against client expectations

Managed site issues utilizing, Project Manager, Statement of Work and site contact

Site monitoring determination, reflex testing

Accomplishments:

Facilitated soft skills and leadership training programs on; Mentoring, Motivation, Diversity, Coaching for Leaders, Peer Facilitation, Lunch and Learn

COVANCE CENTRAL LABS SERVICES - 2004 - 2008

Resource Management

Consultant for Cost Estimation database, task metric analysis to determine FTE necessity

Maintained monthly reports and served as upper management liaison

Accomplishments:

Project Management lead involving the creation, initiation and implementation for new kit ordering process globally. Ace and Bravo award

Customized Presentation Skills eliminating external client fees, Signature

Client Services Presentation at the request of management

COVANCE CENTRAL LABS SERVICES 1998 – 2004

Senior Administrator - Reference Laboratory Interface

Served internal and external customers as a technical expert of the Reference Laboratory Interface Department

Maintained accurate FDA compliant protocol specifications relating to medical data transfer, specification documentation, and format design and implementation

Accomplishments:

Trained and organized new department globalization in Geneva

Created process improvement for site requisition form. Ace and Bravo award

Facilitated presentations for Reference Laboratory Interface Department

NASSER SMITH AND PINKERTON/DIAGNOSTIC INTERNAL MED 1990 - 1996

Front and Back Office Medical Assistant / Trainer and Supervisor

Trained front and back office Medical Assistants

Clinical Research Study Coordinator/Trainer

Trained employees on Regulatory Compliance

Obtained HMO authorizations

Assisted in coding, billing / insurance claims processing, and collections

Scheduled appointments, tests and surgeries

Other responsibilities included supervision and training of staff, physician credentialing, transcription, facility maintenance and inventory of supplies and equipment

CONTINUING PROFESSIONAL EDUCATION & SEMINARS

Indiana Tech Bachelors Degree Organizational Leadership

Degree Pending 6 Classes

Minor: Training and Development

PCI – Medical Assisting – Graduate 1988

Facilitations/Certification

Coaching Skills CMOE Certification

DDI Certification – Soft Skills Training

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