Project manager
Resume:
Melissa A. Boudreau, LPN, CTM, CRC
Hendersonville, TN 37075
*********@*****.***
Qualifications & Achievements
• CPR certified
• Phlebotomy trained
• IV certified
• Electronic Data Capture certified
• Pulmonary Functions Testing certified
Experience
Sarah Cannon Research Institute
Oncology Clinical Trial Manager, February 11, 2009 to present
- Participates in Phase II-IV oncology clinical research studies conducted by the principal investigator(s) and sub-investigator(s). Coordinate and participate in a variety of complex activities at clinics, including but not limited to, collection, documentation, and compilation of clinical data. Works closely with the clinic physicians (sub-investigators), principal investigators, project manager, research nurses and other study team members.
DUTIES INCLUDE:
• Works with the research nurse to lead the execution of trials in the clinics
• Develop and communicate guidelines in the collection of clinical data and/or administration of clinical studies at designated clinics
• Responsible for tracking of all assigned clinical activity at assigned clinic
• Submits the list of study drugs provided to the research pharmacist weekly
• Submits the list of central lab kits needed. Interfaces with the clinic lab technician to ensure appropriate lab kits are used and processing of specimen is complete
• Assists the research nurse in completion of SAEs, protocol waivers and protocol deviations
• Proactively identifies trial-related issues and provides recommendations for resolution
• Initiates improvements to enhance the efficacy and the quality of the work performed on assignments
• As directed by the research nurse, provides support in the enrollment of patients onto IIT and IST clinical trials through active screening of potential study patients charts
• Assists the research nurse in reviewing the protocols and eligibility criteria with the physician
• Ensures the safety and welfare study patients
• Attends staff meetings and participates in startup training for new studies
• Performs/administers/ and/or documents all specific tools/tests required by the protocol (i.e. oral medication forms, pill count diaries, QOL questionnaires, times of PK draws, EKG, etc. under the supervision of the research nurse.
• Ensures that all medications, including antiemetic, are approved by the registrar prior to initiating treatment or when changing medication regimens.
• Communicates with study manager to ensure compliance with protocol guidelines
• Ensures that follow-up appointments, scans or any related procedures are scheduled correctly according to protocol requirements.
• Obtains pathology reports, scan reports, as required by protocol
• Assists in completing patient tracking logs
• Completes and submits payment tracking logs
• Participate in training of all new protocols
• Obtain signatures from sub-investigators per regulatory guidelines
• Accurately completes all data and query requests and submits source documentation as necessary
• Assist study managers with chart requests from clinics
• Adheres to appropriate Standard Operating Procedures
• Maintains patient confidentiality according to ethical and legal requirements
• Practice and adhere to “Code of Conduct” philosophy and “Mission and Value Statement”
• Ensures adherence to protocol with knowledge of GCP and IHC
Alpha Clinical Research, LLC
Clinical Research Coordinator, July 5, 2005 to February 4, 2009
Work one on one with patients. Responsible for patient visits, protocol compliance, blood draws, completing source documents and case report forms, completing submission for IRB.
TN Health Care Careers, LLC
Instructor, February, 2007 to May 2010
Instruct certified nursing assistant students. Responsible for student assignments, ensure that students provide proper care for patients within state guidelines, observing student procedures, helping students prepare for state testing.
Premier Medical Group
LPN, October 2000 to March 2010
Assist doctors by rooming patients and assisting with procedures such as EKG, pap smears, and minor surgical procedures. Responsible for obtaining vital signs and carrying out doctor’s orders. Pediatric experience.
Spring Meadows Healthcare July 2001 to July 2005
Administrate MDS nurse, Administrative Wound Care Nurse, July 2001 to July 2005
Responsible for submitting Material Data Sets to the state and wound care. Able to stage and determine correct treatment for wounds. Preventive skin care.
Education
Registered Nurse
Hopkinsville Community College, Hopkinsville, KY
2003-present
Licensed Practical Nurse
TN Technology Center, Paris, TN
1998-1999
IV Certification
Henry Count Medical Center, Paris, TN
1999-1999
Education
Austin Peay State University, Clarksville, TN
1993-1995
License:
LPN 000*******
Therapeutic Areas:
Oncology:
Breast
Lung
Gastrointestinal
Prostate
Carcinoid
Non Oncology:
Cardiovascular
Kidney disease
Diabetes
Pain
Low Testosterone
Dialysis
Chronic Kidney Disease
Geriatrics
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