Customer Service Quality Assurance

Address: *** **** ******

New Cumberland, PA *****

Home: 717-***-****

Mobile: 717-***-****

Email: ************@*******.***

Sara (Koval) Hayes

Experience 02/2010 – present Gettysburg Cancer Center Gettysburg, Pennsylvania

Clinical Research Manager

• Manage all phases of clinical trials and associated patient and research activities for busy oncology practice at multiple locations.

• Actively participate in patient recruitment, enrollment and continuum of care.

• Manage all incoming budgets and contracts for clinical research trials with vendors, sponsors and CROs.

• Key role in Initiation and Monitoring visits as well as other visits and/or meetings as needed.

• Responsible for site documentation including, Regulatory Binder, Safety Reporting, and Patient CRFs.

• Maintain training for all active EDC systems for patient CRF completion, queries and reporting. Complete all eCRFs and answer queries with assistance from the Research Nurse.

• Liase with community physicians and practices for networking potential as well as expanding access for patient care to the best possible facilities as well as treatments.

• Attend workshops and trainings for most current with medical practices, compliance guidelines, treatments and research.

• Currently working on RN degree as well as CCRA certification.

10/2008 – 02/2009 Lantheus Medical Imaging (c/o BioBridges) North Billerica, Massachusetts

Clinical Trial Associate

• Short term contractor for essential Phase 2 Study Start up. Key program with high level priority.

• Actively participated in site and local Radiopharmacy identification.

• Managed all active site activities including document collection and disbursement, budget and contract negotiations, informed consent revisions, IRB submissions and vendor communications.

• Key role in setting up as well as directly managing regional Investigator Meetings for active and potential sites.

• Responsible for document creation and revisions of key parts of the Study Procedures Manual, including writing key sections and editing previous versions for use with new projects and recent discoveries for assisting the site use the product.

• Acted as a liaison with the Clinical Program Manager and other working parts of the Clinical team. Acted as the Trial Lead up until a new candidate for the position could be trained and acclimate.

11/2007 – 05/2008 Biopure Corporation Cambridge, Massachusetts

Clinical Research Associate

• A key player in the close knit Clinical Operations team. Created, updated and maintained major regulatory documents such as new Study Protocols, Informed Consents, and Investigator’s Brochures.

• Actively participated in teleconferences and meetings involving FDA, potential Investigators and interdepartmental relations.

• Managed international CRAs in Greece and South Africa.

• Key role in Compassionate Use program, involved travel to deliver product to physicians in emergency situations as well as quality assurance with sites, data collection and product usage.

• Major player in regulatory submission both internationally and domestic.

• Developed monitoring skills with wide range of Phase 2 programs and Compassionate Use program, primarily involved in day to day managing of Trauma Trial to take place in Australia.

• Involved in many day to day administrative responsibilities, including correspondence, communications, meeting minutes, conference and interdepartmental meetings, both domestic and international. Also coordinated travel arrangements with other team members in situations as necessary.

03/2005 – 10/2007 Genzyme Corporation Cambridge, Massachusetts

Clinical Research Coordinator II/ Jr. Clinical Research Associate

• Gained experience with monitoring at local sites, attended site visits with a various experienced CRAs.

• Liaised between Investigators, sites, vendors, contractors and Genzyme.

• Assisted with management of vendor and Investigator payments and contract milestones.

• Utilized major multi-tasking skills with three major ongoing program teams with 3 to 4 projects within each team, in different Phases of Clinical Research and human trials. A Late-Onset disease trial in Phase 3 in a high profile fast paced team environment post FDA approval, a high profile Phase 4 trial that is being closed out, a new Phase 4 trial starting with international subjects, and a Phase 1 high profile team in the beginning stages of human trials.

• Worked with Electronic Data Capture (EDC) programs, major intranet, and server-associated programs. Including Phase Forward’s InForm, eTrials, IntraLinks, LiveLink, Covance’s LabLink and FTP servers.

• A SuperUser on the new repository software system.

• Proficient use of MS Office programs such as Outlook, Word, Excel and PowerPoint.

• Excelled with writing and editing as well as daily internet research for products and information on the web.

• Manage meeting minutes as well as merging different edits from team members into one complete document, then editing for content and consistency, after which a final review and edit occur before sign off.

• Maintain regulatory documents and files both national and internationally.

• Confident communicator to teams, managers and sites nation and worldwide.

• Able to work well independently without direct daily supervision as most projects require autonomy and self-managing. Able to collaborate with other members of the teams to get work done in a positive, cohesive manner. Able to pick up new tasks and learn quickly as is the case with the new developing skill of monitoring.

• Key player in the training of new CRCs as they join teams and acclimate.

03/2005 – 09/2005 Genzyme (c/o Randstad N.A) Cambridge, Massachusetts

Contract Clinical Research Coordinator I

• An integral team oriented position in the Niemann-Pick Program. Responsible for data and file management for multiple studies both in the US and abroad.

• Maintain accurate meeting minutes as well as attend key team meetings.

• Negotiate timelines and multi-task between projects depending on the urgency and deadline. Communicate with key senior team members as well as physicians and their staff.

• Review all study documents and incorporate comments and revisions from various cooperative departments, while also keeping team within deadline commitments.

• Update milestones and keep internal server file systems updated. Maintain study documents within pre-determined operative guidelines.

• Key role in project related tasks. A valued member of the team and necessary asset to company.

12/2001 – 03/2005 New England Eye Center Boston, Massachusetts

Patient Service Coordinator II / Glaucoma Clinic Coordinator

• Managed clinical and scheduling aspects of glaucoma service between three ophthalmologists in outpatient clinic environment in Boston.

• Mastered all basic and intermediate office skills and gained valuable work experience. Utilized all major and minor office skills and gained valuable work experience. Proficient with Microsoft Word, Outlook, and Office applications.

• Use internet daily. Steadily increased dependability and currently taking on more management responsibilities.

• Assisted in training subordinates in current and associated clinics. Able to accomplish successfully all front office duties required by position.

• Exceeding ability to adapt and multi-task and positive asset to individual attending physicians as well as team of co-workers.

10/1999 – 2/2000 Apple Hill Eye Center York, Pennsylvania

Medical Secretary / Transcriptionist

• Responsible for front office duties in busy professional ophthalmologists’ office.

• Regular duties included answering multi-line phone system, copying, faxing, printing, and exchange of funds for office visits and customer service.

• Transcription duties included co-managing transcription department, filing patient files, transcribing doctors’ notes into patient charts, correspondence to patients, other specialty doctors, and fellow ophthalmologists.

9/1999 – 10/1999 Hanover Orthopaedic Associates Hanover, Pennsylvania

Internship: Medical Secretary

• Responsible for front office duties such as multi-line phone and basic office equipment.

• Filed patients’ charts and helped patients to their observation rooms.

• Assisted in collections of insurance monies and delinquent patient bills.

9/1998 – 12/2000 Pearle Vision Express Hanover, Pennsylvania

Optical Professional

• Responsible for greeting customers and assisting in their optical needs.

• Helped to find the appropriate eyewear necessary for individual needs. Also fit eyewear, took the proper measurements, final check quality, and dispensed eye wear.

• Eye wears included contact lenses and eyeglasses. Repaired eyeglasses and adjusted the tinting on eyeglass lenses.

• Handled customer service via the telephone and in person.

• Dealt with insurance information with both the customer and insurance companies.

Education

08/2010 Harrisburg Area Community College Harrisburg, PA

Accepted into ADN Program for RN

12/2009 Pennsylvania State University Mont Alto, PA

College Coursework Completed

12/2007 Harvard University Extension Program Cambridge, MA

College Coursework Completed

05/2006 University of Massachusetts Boston, MA

College Coursework Completed

11/1999 Consolidated School of Business York, PA

Certification

Medical Office Specialty Diploma with emphasis in medical transcription

12/1998 Slippery Rock University Slippery Rock, PA

College Coursework Completed

5/1998 Delone Catholic High School McSherrystown, PA

High School Diploma

Certification

3/2011 ACRP CCRA Certfication Harrisburg, PA

To take Certification Exam in March

Contact this candidate