Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various hospitals and clinical research organizations where she recruited and consented patients, collected data, tracked regulatory documents, and ensured compliance. Hamm has a Bachelor's degree in Business Administration and is certified as a phlebotomist.

1. Melissa Hamm, B.S.
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MELISSA ALEXANDER HAMM
622 E. Knox Street Apt R. Durham, NC 27701
spain0313@hotmail.com
(919) 884-1739
OBJECTIVE
To obtain a challenging position where I can share my knowledge and experience to the service of an
organization thus contributing to the fulfillment of the objectives and the mission of that company, always
observing; the ethical principles of honesty, professionalism and confidentiality. To provide a long term
commitment to the company.
EDUCATION
Shaw University, Raleigh, NC May 2009
Bachelor of Science Degree (B.S.), Business Administration, Concentration in Management
Graduated Cum Laude with a GPA of 3.2 on a 4.0 scale
Durham Technical Community College, Durham, NC
Certification: Phlebotomy, ASCP, 1996
THERAPEUTIC AREA OF EXPERIENCE
Gastrointestinal (GI) Hepatology: Hepatitis C
Oncology: Prostate, Lung, and Bladder
Infection Disease: HIV c/o infected w Hepatitis C
PROFESSIONAL EXPERIENCE
Procom – Raleigh, NC (Contract)
UNC
Clinical Research Study Coordinator – Lung, Bladder Oncology Dec 2015-August 2016
 Perform independent and dependable work in preparation and coordination of study.
 Respond to Sponsor on behalf of the PI when appropriate.
 Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous
and professional manner; Meet with study sponsor representatives as needed.
 Attend IRB, study sponsor, or any other meeting in place of the PI.
 Address queries and memos from IRB and other committees create draft response to query’s for PI
approval.
 Maintain and organize electronic and paper regulatory documents, study files and patient binders.
 Perform Quality Assurance/Quality Control of Study files
 Track and enter regulatory submissions using electronic databases and prepare reports within the
databases.
 Respond to all queries and adverse events in a timely manner.

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 See clinical trial patients, follow up with phone calls and make sure all protocols are followed.
 Responsible for screening and recruitment of clinical trial patients for assigned studies.
 Communicate to PI potential issues to regulatory supervisor, study team members, and investigators.
 Assist other staff members in completion of work in a team oriented environment.
 Complete other regulatory duties as assigned.
 Communication, Teamwork and Compliance
 Use effective verbal and written communication to accomplish tasks.
 Technical ability to apply the knowledge of research principles when collecting, editing, analyzing the
data and reporting data/information related to the study.
 General computer, technical knowledge, and understanding of patient input data bases.
 Capability of identifying discrepancies in database information.
 Ability to problem solve, extreme organization skills, and attention to detail.
 Ability to work as a productive member of a team by helping develop solutions to meet group needs as
well as the structure of the team.
 Coordinate and preside over Startup and SIV meeting.
 Work effectively with patients, medical faculty and staff.
 Assist Sponsor Monitor during their visit.
 Ability to understand and implement protocols and teach them to clinic personnel.
 Able to implement clinic clinical trials based on FDA and good clinical practice guidelines and work
independently.
 Knowledge of research principles and methods to interpret, and coordinate the collection and analysis of
data/information related to the research.
Ascent (Contract)
PPD
Medical Communication Specialist I (Diabetics Device) Nov 2015-Dec 2015
 Provide appropriate and accurate technical information while maintaining excellent customer service.
 Research and respond to inquiries.
 Responsibilities also include identifying and recording adverse events and product complaints.
 Work closely with internal and external client contacts to resolve customer and HCP issues.
 Maintain knowledge of policies and procedures including client product, SOPs, protocols, GCPs and FDA
regulations.
Starwood Hotel – Aloft, Durham NC USA
Front Desk Talent, Night Audit Jul 2015 – Nov 2015
 Manage and lead the overall hotel operations, reconciliation of posting all revenue on the moonlight shift.
 Functioning as an accountant, agent, and host.
 Run accounts receivable, bank balance, credit card verification, and other financial transactions with in the
hotel.

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 Ensure that all guests are greeted and welcomed to a clean and prefect hotel.
 Promptly and effectively handle guest requests and complaints.
 First contact for guest issues, calls, and delivery of messages during the night audit.
 Keep all employees and guest information confidential at all times.
 Collect payment, post charges, correct, and adjust charges to guest accounts.
 Follow all Standard Operating Procedures (SOP).
 Answer telephone calls with proper telephone etiquette.
 Open and close shift, make cash drops, ensure credit cards are balanced throughout a shift.
 Provide a professional image by keeping a proper attitude towards guest and co-workers.
 Promote teamwork and self-sufficient.
Duke Cancer Institute, Durham NC USA GU Oncology Research
Clinical Trials Specialist - Prostate Oncology Jan 2013 – Nov 2014
 Worked with the GU Oncology Research Team to assist patient with their prostate cancer treatment.
 Coordinated and performed a variety of duties involved in the collection of data in support of clinical trials
research studies, through clinical assessments, interviews and observation to include interpretation and
documentation of data.
 Followed established guidelines in the collection of clinical data and/or administration of clinical trials.
 Conferred with site coordinators and physicians to explain protocol and to elicit compliance with
regulations; ensure adherence to FDA and protocol guidelines; identify potential problems and/or
inconsistencies and inform supervisors as needed.
 Ensured distribution and maintain inventory of appropriate forms, supplies, equipment, and laboratory
samples required for execution of research protocol(s).
 Compiled protocol specific site reference binder for sites and sub sites.
 Collected data from patient charts, medical records, and other sources for sponsor and investigator
initiated through electronic data capture systems.
 Reconciled data and resolve data queries with sponsors and Clinical Research Organizations (CROs);
collaborating with Nurses, CRCs, and/or providers for clarification.
 Tracked and obtained signatures on source documents.
 Kept research charts up to date and current; prepare charts for future visits.
 Organized and scheduled study monitor visits to ensure that data entry and charts were up to date.
 Created and maintained electronic enrollment logs for all studies, coordinate monthly effort reporting.
 Coordinated electronic Research enrollment validation with regulatory team leader for each protocol.
 Mentored and trained new data personnel for new studies.
 Accessed and provided feedback on staffing productivity, quality, and communications.
 Sent request to PRMO for Grant Patient Scheduling via Maestro In-Basket.
 Verified patient’s appointments and orders for future visits.
 Maintained study finance trial tracker.
Duke School of Medicine, Durham NC USA GI Hepatology
Clinical Research Coordinator I – Hepatitis C, HIV Mar 2011-Jan 2013
 Worked with GI / Hepatology Research with patients that were Hepatitis C infected.
 Discussed with study participants the purpose of study and obtain informed consent.
 Explained the diagnostic procedures to alleviate patient concerns.
 Scheduled patient for laboratory procedures based on standing protocol orders.

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 Collected data from patient charts, medical records, interviews, questionnaires, diagnostic tests and
other sources; prepare appropriate documentation; obtain blood samples, cultures, tissues and other
specimens for laboratory analysis.
 Ensured compliance with protocol guidelines and requirements of regulatory agencies.
 Identified problems and/or inconsistencies and monitor patient’s progress to include documentation and
reporting of adverse events; recommended corrective actions as appropriate.
 Discussed with principal investigator(s) in developing plans for research projects. Coordinate the
development of forms, questionnaires and the application of research techniques; write procedures for
data collection and coding.
 Obtained information regarding previous studies to aid in the planning of new studies
Duke Clinical Research Institute, Durham NC USA GI Hepathology
Clinical Trials Specialist - Hepatitis C 2010-2011
Clinical Trials Assistant II – Hepatitis C 2008-2010
Clinical Trials Assistant I – Hepatitis C 2006-2008
 Implemented clinical trials repository procedures within a large Hepatitis C repository research project.
 Reorganization and re-identification of over 25,000 human samples in cryogenic freezers and
databases.
 Consented subjects within protocol-specified visit windows.
 Obtained human samples through venipuncture, processed, and stored according to SOPs
 Retrieved fresh liver tissue from physician after biopsy was completed processed tissue for repository
archival.
 Accurately entered all demographic, clinical, and sample information in three Duke University databases.
 Accurately obtained clinical data on research subjects through the use of paper chart and electronic
browser.
 Acknowledged Pharmaceutical adverse event and serious adverse event reporting.
 Provided excellent customer support including problem intervention/resolution.
 Daily recorded and monitored research refrigerator and cryogenic freezers.
 Facilitated completion of clinical charts and case reports forms.
 Controlled quality of data retrieved from hospital reports and reported research activities to team
members.
 Assisted with creating queries for sample pulling, aliquoting and disbursement to research collaborators.
 Create SOP’s guidelines for the collection of specimens and clinical data for new protocols.
DUHS Clinical Laboratory Department
Laboratories: Inpatient and Outpatient Clinics, Coagulation, Chemistry, Carl and Franklin Core
Clinical Lab Support Technician (1986-2004) / Certified Phlebotomist (1996-2014)
 Promoted to a senior level phlebotomist with administrative responsibilities for a department of twelve
 Performed Bleeding Time – determined platelet and capillary function.
 Performed Blood Cultures – determined bacteremia.
 Perfected venipuncture blood draws for pediatric and geriatric; inpatient and outpatient, pre-op and post-
op.
 Executed and Completed Urine, Blood HCG Test, and glucose tolerance test (GTT); 2, 3, & 5 hour.
 Coordinates and assisted other team members in venipuncture, subject reaction care, and with difficult
venipuncture
 Provided licensed staff an extension in their duties by managing the blood services regulations and
documentations.

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 Prepared weekly schedule for coverage in Outpatient Clinics.
 Responsible for the accurate processing and data entry of a wide variety of clinical sample
 Trained staff on equipment operation and procedures.
 Maximized lab performance through organization, equipment testing and procedure development.
 Performed venipuncture, centrifuge blood samples, as well as aliquot.
 Skilled in trouble-shooting and maintenance of technical equipment.
 Coordinated Safety classes for team members.
 Organized chemical, safety books, and classes for safety officers.
 Supervise Centrifuge Maintenance: RPM, Clean, and Repair as needed.
 Checked incoming specimen for proper identification.
 Maintained proper procedures for using DHIS, Cerner terminals during failures.
 Prepared differential slides and blood smears.
COMPUTER SKILLS
Proficient input and output of database collection for Gilead Medidate RAVA, Velos eResearch, Hepatitis B
research Network, PRISM (Research Information/Site Management), Center for Human Genetics Pedi gene
(CHG Application / DNA Bank), IDX, eBrowser, CAISIS, Oracle (PPDI and Duke), Timaeus, Inform, and EPIC /
Maestro Care, knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management
System (EDMS), MS-Office products such as Excel and Word, CASCADE, OnCore, CTSU/CTEP, Merge
(IVRS), ACCRU, Vestigo, Merge (eclinicalOS), Perceptive, MedImmune, and Infosario(Quintiles/Quest).
ADDITIONAL SKILLS
ICH GCP, HIPAA Privacy and Security, Ethics of Human Subjects Research, Basic IRB Regulations,
Federal/State Regulations, Blood Safety, OSHA Blood Bourne Pathogens, Biological Safety, Incident reporting,
Safe Specimen Collection, and Bio-Specimen Shipping.
LICENSES and CERTIFICATIONS
 Certified Phlebotomist – American Society of Clinical Pathology (ASCP) 1996-present
 CPR 1996 (recertified every 2 years) 2015
 CCRP (pending exam October 2016)
HONORS AND AWARDS
 Dean’s List – Shaw University
 CHI ALPHA Society
VOLUNTEER AND COMMUNITY ACTIVITIES
 Order of the Eastern Star (OES)
 To serve the community. Assistance every year with Toy Give Away in the
Durham County Low Income Housing Communities.
 CAARE, Inc.
 Provide effective prevention services to at-risk persons and their families in
Durham by utilizing resources that address the health and social needs of the
community.

6. Melissa Hamm, B.S.
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 Dress for Success: Going Places Network (GPN)
 Help women living in poverty change how they see themselves. It begins with a new
look, along with coaching, resume support and job placement assistance.
LANGUAGES
Native Tongue is English