Clinical Research Nurse
Resume:
Michelle Anne Hofmann, MSN, RN, BBA
*** **** **** ****, *******, NJ 08833 ! PH: 908-***-**** !
************@*****.***
SUMMARY
Highly motivated Advanced Practice Nurse with experience in the Biotechnology, Surgical and Pharmaceutical arenas. Clinical expertise in multiple specialties including Neuroscience, Cardiovascular, and Oncology. Experience in sales and marketing with excellent customer communication and presentation skills. CORE STRENGTHS AND EXPERIENCES
Medical devices / Pharmaceuticals ! ! Pharmacology
Neuroscience! ! ! ! ! Cardiovascular
Oncology! ! ! ! ! ! Project Management
Deliver clinical presentations ! ! ! Clinical trials and research
Data analytics! ! ! ! ! Team Leadership
Business planning ! ! ! ! Attention to detail
Strong collaboration! ! ! ! Excellent communication skills !
Market research! ! ! ! ! Ability to work independently
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KEY ACHIEVEMENTS
Nominated Nurse of theYear by my peers at Atlantic Health System.
Published clinical research study on childhood obesity metabolic disorders.
Key member of multiple new product launch teams that contributed to strong sales and marketing results.
Recipient of numerous Atlantic Health Systems Achievement Awards PROFESSIONAL EXPERIENCE
CLINICAL RESEARCH COORDINATOR - Phase 1 Research
HACKENSACK UNIVERSITY MEDICAL CENTER- John Theurer Cancer Center 6/2020 - CURRENT
Responsible for the enrolling patients into Phase I Clinical Trials. Manage all aspects of conducting clinical trials. I have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, I act as liaison between the investigators, primary care providers, the Institutional Review Board (IRB), the Office of Clinical Research (OCR), and the sponsor. Along with the investigator, I will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, I am responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. Key responsibilities as a Clinical Research Coordinator at Hackensack Meridian Health includes:.
• Follows patient accounting procedures and schedules all testing required by the trial protocol.
• Completes clinical research requisitions and works directly with patient registration to identify which testing is study related. Utilizes the V70.7 diagnosis code to identify study related procedures.
• Ensures that patient billing is not generated for procedures covered by the clinical trial protocol
• Follows procedures for case report form (CRF) preparation and completion Ensures timely and accurate CRF completion for each study subject.
• Keys data for remote data entry or provides completed CRFs on a timely basis.
• Reviews keyed data for accuracy. Maintains source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports.
• Provides auditors with completed CRFs, medical records, lab data and other source documents for review.
• Corrects and edits CRFs as appropriate.
• Responsible for the sound conduct of clinical trials within clinical discipline Adheres to the Code of Federal regulations when conducting research.
• Ensures that all state and federal standards are followed.
• Abides by the Standard Operating Procedures and institutional IRB.
• Participates in the internal auditing process and contributes to the Quality Improvement Process.
• Complies with Hackensack Meridian Health's Corporate Compliance Department.
• Actively participates in ongoing research specific quality assurance activities such as chart audits for protocol compliance.
• As needed, serves as a mentor/preceptor to new CRC's. Communicates effectively with staff and outside agencies, and assists in the promotion of teamwork.
• Contributes to the Office of Clinical Research spirit de corps.
• Attends study investigator meetings as needed.
• Maintains accurate and complete documentation IRB submissions are accurate and complete.
• Adheres to screening and enrollment procedures.
• Reviews and verifies all relevant source documentation in the subject's medical record to confirm study eligibility.
• Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects.
• Ensures the current approved informed. consent is signed before subjects are screened and enrolled.
• Ensures that the randomization procedure is followed as per protocol guidelines.
• Meets enrollment targets.
• Processes specimens according to protocol and IATA Guidelines.
• Ensures positive relations with study sponsors.
CLINICAL RESEARCH COORDINATOR
NUVANCE HEALTH - WHITTINGHAM CANCER CENTER
10/2019- 6/2020
Responsible for the enrolling patients into Phase I,II and III Clinical Trials, Translational and Genomic Profiling Trials.
Key responsibilities include:.
Acts independently as primary liaison between Nuvance Health and national cooperative groups and pharmaceutical industry to coordinate clinical and data management.
Managing approximately 60 active patients.
Area of Speciality in Oncology Trials: Breast, GI/GU and GYN.
Assists the Principal Investigator in the assessment and feasibility of prospectives studies.
Develops a budget and tracks revenues and expenses of research program.
Maintains ongoing communication with Nuvance Health’s IRB including submitting applications.
Develops and obtains informed consent.
Collects accurate and timely data, assuring protocol and treatment schedules are adhered to.
Constructs or monitors case report forms.
Educate patients and families about protocol including treatment plan, adverse effects.
Educates health care professionals including physicians, nurses, pharmacists, psychosocial personnel and others to promote coordination of care of patients on study.
Refers patient for medical, nursing and psychosocial issues to appropriate member of healthcare team.
Participate in audits for compliance with all regulatory requirements.
Establishes a system for case finding and recruitment of eligible patients for clinical research trials.
Screens patients for eligibility for clinical trials.
Assesses patient for toxicities and reports adverse events immediately with required documentation.
Performs follow-up physical exams and manages side effects when indicated.
Attends and contributes to interdisciplinary team meetings, programs and conferences when appropriate.
Communicates with team members on an ongoing basis.
Contributes to the development of CQI plan for the Cancer Center
Promotes the research program within the organization.
Good Clinical Practice (GCP) Certification
IATA Certification and Human Subject Research (HSP) Certification CLINICAL TRIAL STUDY AWARENESS LIAISON
HEALTH PERSPECTIVES GROUP, LLC
5/2019-9/2019
Regional field-based team member responsible for engagement with patients, caregivers and HCPs, advocacy organizations, and specified patient groups to create study awareness, accelerate volunteer accrual, and building sponsor understanding assigned market dynamics.
Key responsibilities include:
Utilize MLR and IRB approved materials to inform HCPs, advocacy organizations, and patient support groups in the community setting on the sponsor’s clinical study programs, educate patients about the study; and conduct in-field eligibility screening, as appropriate.
Develop patient advocacy relationships at the regional and local level.
Attend local advocacy events to generate study awareness and to initiate patient study education and engagement.
Explore potential to engage local media outlets (e.g., public interest coverage).
Garner feedback that will inform critical decisions that will impact the communities served.
Provide insight and feedback to clinical study centers, as needed.
Participate in meetings (in-person and/or remote) that relate to program-specific initiatives, process, improvements or other critical updates; Collaborate with Clinical Operations/CRO, Medical Affairs, Commercial Operations, Medical, and other internal teams.
Document interactions in the appropriate systems dictated by HPG policies and procedures
Information capture, including program specific PHI and PII, into proprietary HPG secure database platform.
Good Clinical Practice
ADVANCED PRACTICE NURSE
MENDHAM TOWNSHIP SCHOOL DISTRICT
2014 - 2019
Coordinate and deliver healthcare services in compliance with NJ Department of Health Regulations, and school district policies. Key responsibilities include:.
Promote a safe and health school environment through nutrition and exercise programs
Conduct mandated health screenings, physicals and special education assessments in a school composed of 340 students. Ensure follow-up when dictated.
Pharmacological and non-pharmacological management and treatment of various disorders and diseases.
Counseling in health maintenance and disease management through educating community members.
Process monthly reports for department performance.
Increase public awareness of food safety issues through regular education.
Assess and respond to individual and community health education needs.
Collect and analyze data enumerating the effectiveness of programs in place. REGISTERED NURSE
OVERLOOK MEDICAL CENTER / ATLANTIC HEALTH SYSTEM - NEUROSCIENCE INSTITUTE
2006 - 2016
Register Nurse on the 28-bed Neuroscience Unit. Responsible for all aspects of delivering patient care including:
Experience with multiple neurological disorders including Parkinson’s Disease, Dementia, CVA, Alzheimer’s and Paget’s Disease, additional experience with conditions such as Diabetes and Cancer.
Assessed need for, ordered and interpreted appropriate lab tests.
Pharmacological and non-pharmacological management and treatment of various disorders and diseases.
Ensure compliance for patients enrolled in clinical trails.
Evaluated patient care needs, prioritized treatment, and maintained patient flow.
Assisted doctors with surgeries and non-invasive procedures.
Facilitated an on-going assessment of patient/family needs and implementation of interdisciplinary team care.
Educate staff on new medication and/or medical devices to ensure they are dispensed, administered and used safely.
MARKETING AND MERCHANDISING MANAGER - US Market
NOKIA CORPORATION
1998-2000
Responsible for marketing and merchandising cellular phone technology. Supported new product launches through the creating of marketing material, display fixtures, and new product training for retailers. Management Experience is managing up to 10 employees on my merchandising team and managing outside merchandising vendors. Experiences include:
Collaborated with internal business divisions, agency partners and local vendors to guarantee timely, cost effective delivery of marketing communications materials.
Worked closely with clients to identify their needs and challenges and provide solutions-oriented campaign.
Organized store merchandise for best market placement
Traveled to the market, vendors and assisted buyers with merchandise selection.
Partnered with sales representatives and managers to coordinate delivery and merchandising schedule.
Preserved brand integrity by monitoring the consistency and quality of marketing content.
Cultivated effective partnerships with engineering, marketing, sales and customer support staff.
Reviewed financial aspects of product development; budgets, expenditures and R&D appropriations.
Initiated market research studies and analyzed findings to create effective messaging.
Coordinated and participated in promotional activities and trade shows.
Coordinated art and graphics creation for effective merchandising. MARKETING MANAGER
SHARP ELECTRONICS
1996 - 1998
Responsible for marketing and promotion of Home Office product line. Launched multiple new products for the US market, and managed product lifecycle for replacement of new technology. Management experience is managing outside merchandising vendors to ensure product material are distributed and merchandise correctly out in the field.
Key responsibilities include:
Conducted market research to identify customer needs and opportunities for growth and development.
Developed new product value proposition, positioning statement and customer messaging.
Collaborated with agencies and graphic designers to develop packaging and sales collateral.
Coordinated and presented promotional activities and trade shows.
Directed art and graphics creation for effective merchandising.
Develop and launched incentive programs to motivate sales representatives to exceed sales quotas.
ACCOUNT MANAGER / SALES REPRESENTATIVE - 3 State Territory CAMPBELL SOUP COMPANY
1991 -1996
Managed multi-million dollar territory across Pennsylvania, New York and New Jersey for frozen food product line. Consistently achieved quarterly quotas, with excellent customer relationships.
Key responsibilities include:
Primary point of contact for customers within territory
Introduced new products through customer presentations and sampling
Negotiated pricing agreements to maximize company revenues and profits
Prompt attention to customer concerns to ensure high level of customer satisfaction
Consistently achieved and exceeded sales goals by 20%. EDUCATION
Master of Science Nursing, 2016
Fairleigh Dickinson University –Teaneck, NJ
Associate of Science Nursing, 2007
Raritan Valley Community College - Branchburg, NJ
Business of Administration, Emphasis in Marketing, 1990 Susquehanna University – Selinsgrove, PA
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