Clinical Coordinator Business Development

Proposal Manager-Writing

Michelle Edwards, R.N., B.S.N.

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

EDUCATION

Bachelor of Science, Nursing, 1995

East Carolina University, Greenville, NC

THERAPEUTIC EXPERIENCE

Infections/Parasitic Diseases: Methicillin-resistant Staphyloccocus aureus (MRSA), vancomycin-resistant Staphyloccocus aureus (VRSA), Clostridium Difficile, various Herpes infections, Varicella Zoster, Tuberculosis (TB), Vancomycin-resistant enterococci (VRE), HIV, Malaria, Smallpox, Anthrax

Oncology: Colon, Rectal, Anal, Lung, Breast, Pancreatic, Liver, Skin, Brain, Prostate, Bladder, Hodgkin’s lymphoma

Endocrine/Metabolic: Diabetes, Thyroid Disorders, Hydradenitis

Circulatory: Hypertension, Peripheral Artery Disease, Venous Insufficiency, Pulmonary Hypertension, Portal Hypertension, Cardiac Transplant

Nervous System/Sense Organs: Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), Seizure disorders, Dementia, Alzheimer’s Disease, Parkinson’s Disease, Peripheral Neuropathy

Respiratory: Chronic Obstructive Pulmonary Disease (COPD), Asthma, Pneumonia, Influenza, Lung Transplant, Tuberculosis

Digestive System: Peptic Ulcer Disease, Hepatitis, Diverticulosis, Diverticulitis, Acid Reflux Disease, Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Crohn’s Disease, Colovaginal Fistulas, Rectovaginal Fistulas, Anal Fissures, Anal Fistulas, Pelvic and Anal Pain, Colonic Strictures, Colon Polyps, Rectal Prolapse, Liver Transplant

Genitourinary: Colovesical Fistulas, Benign Prostatic Hypertrophy (BPH), Stress Incontinence, Labial, Scrotal, and Anal Abscess, Condyloma, Renal Transplant

PROFESSIONAL EXPERIENCE

Proposal Manager-Writing/ Worldwide Clinical Trials

Proposal Manager-Writing Feb 2023 – Present

Proposal Manager-Writing duties

• Responsible for consistently producing and writing high quality, customized

proposal text across multiple RFPs.

• Identify, advise, and compile winning proposal strategies. Determine key selling

messages in cooperation with subject matter experts (SMEs).

• Act as focal point for collection of information from various sources. Interviews

SMEs to gather information, confirm data and customize content.

• Actively participate in creative writing tasks ensuring that product/service offerings

are clearly articulated in proposals, statements of work, and presentation

materials.

• Must apply strategic and customized solutions to the overall proposal documents.

• Proofread, edit, rewrite, and review budgetary sections of materials to ensure

readability and consistency of message and tone.

• Participate in departmental initiatives as requested by Strategic Proposal

Management leadership.

Senior Proposal Associate/ MCRA

Senior Proposal Associate Jun 2022 – Feb 2023

Senior Proposal Associate duties

• Orchestrates all proposal activities to include budget preparation, generation of the strategic overview/approach and proposal text

• Coordinates the interaction with Business Development (BD) and subject matter experts (SMEs); e.g., clinical, regulatory, and scientific, during the RFP development process

• Ensures the RFP processes are followed and that the appropriate strategic discussion occurs during RFP team strategy meetings

• Accountable for the development and maintenance of the collective RFP Library

• Develops and enhances knowledge sources, guidelines, and templates for the department

RFI Writer II/ ICON, formerly PRA Health Sciences

RFI Writer II Jan 2021 – Jun 2022

RFI Writer II duties

• Develops, writes, and finalizes responses to Requests for Information (RFIs) from ICON clients and prospects

• Coordinates the interaction with Business Development (BD) and subject matter experts (SMEs); e.g., clinical, regulatory, and scientific, during the RFI development process

• Ensures the RFI processes are followed and that the appropriate strategic discussion occurs during RFI team strategy meetings

• Accountable for the development and maintenance of the collective RFI Library

• Creates and edits content for sales and marketing materials for external and internal use

• Develops and enhances knowledge sources, guidelines, and templates for the department

ICON, formerly PRA Health Sciences/Raleigh, NC, United States

Technical Specialist Apr 2015 - Jan 2021

Technical Specialist duties

Acted as Director of Proposals for safety standalone proposals to include orchestrating all proposal activities to include budget preparation, generation of the strategic overview/approach and proposal text

Supported BD by coordinating, filtering and answering all incoming Safety & Risk Management (SRM) related questions regarding RFI and Request for Proposal (RFP) to ensure that the response process is controlled, and the right answers are given by the right person

First judgment on feasibility if RFI is applicable for SRM

Provided input to Central Proposals for project bids to ensure all projects were and would be managed within contractually agreed upon schedules and budgets

Took a lead role in interfacing with existing clients and prospective clients providing technical and business credibility to gain market share to increase the number of business opportunities for SRM

Stimulated sales of SRM services to ensure that there was enough continuity in business unit sales

Supported and educated BD-Team in SRM enabling BD to best present SRM

Supported project teams with generation of change orders covering SRM services

Provided input on client contracts and payment schedules

Pender County Schools, Burgaw, NC

Public School Nurse Dec 2013-Apr 2015

Public School Nurse duties:

Identify and treat health disorders among middle and high school students and provide instruction in

the maintenance of good health and disease prevention

Evaluate the physical conditions of students and refer students to appropriate resources as needed

Prepare health reports for supervisor, board of education and health department

Collaborate with other child-support agencies in designing and providing a school health

Program (PATH – Pender Alliance for Teen Health)

Negotiate professional and medical services essential to the school health program

Provide first aid care and medically prescribed services

Maintain security of school health supplies

Serve as a resource person to school and district leadership on health issues

Provide staff development on health-related topics for school staff and volunteers

Screen and conduct health appraisals and vision-screening for students and staff

Provide follow-up evaluations on students as required

Recommend corrective action where problems are identified

Conduct home visits when appropriate

Correspond with parents, social workers and physicians on health needs of children

Record immunizations, health findings, and other relevant health data

Implemented telehealth in a rural area to bring healthcare to the students, staff and community

PPD, Wilmington, NC Senior Safety Specialist Sept 2010 – July 2012

Project Manager, Medical Monitor Services Jul 2008-Sept 2010

Clinical Research Associate I Jul 2007-Jul 2008

Serious Adverse Event Coordinator Mar 2005-Jul 2007

Senior Safety Specialist:

Responsible for coordinating safety activities for standard noncomplex global/full development/multi-protocol studies, including budgeting, project set-up/close-out, preparation of project specific processes, SAE processing, narrative QC, SAE tracking, coding, reconciliation and identification of project resources needed

Effectively interfaced with project teams, client companies and investigators regarding SAE activities

Mentor Safety Specialists and provide training as needed for project setup, SAE processing and contractual/budgetary processes

Project Manager, Medical Monitor Services:

Manage global budgets and load hours in a financial management tool for Medical Monitor stand alone services

Project hours for Medical Monitor services for global studies that include PVG and/or clinical services

Track Medical Monitor services by task codes to determine if hours are accurate for future bids

Forecast and maintain global budgets for MD only studies. Assist in MD staff projections based on

contract values and actual hours used

Create/review the Safety Medical Management Plan, SMMP, on all MD only studies ensuring that the processes included in the SMMP are reflective of the contract and services requested

Attend weekly project team meetings for studies that are Medical Monitor stand alones or that include listing/coding reviews

Provide input to the Associate Director Medical Monitor Services on contracts and contract modifications and status of contact modifications

Provide estimates for contract modifications and new proposals to the Associate Director Medical Monitor Services to include both domestic and global studies

Establish and maintain a Contract Modification Tracker and present quarterly to upper management for review and discussion

Establish and maintain a tracker on closed studies globally, which includes each position and service contracted, to assess retrospective metrics and make adjustments as needed in bidding algorithms per study indication, Sponsor and Medical Monitor services contracted

Present Retrospective Metrics tracker and findings to upper management biannually

Assist team members with development of standard bidding algorithms

Serve in the role of Project Manager for Europe, Middle East and Asia Medical Monitor only studies and provide monthly oversight to team members regarding study concerns to include financial, quality and staffing risks

Organize and lead monthly calls with team members in Europe, Asia and Middle East to obtain current information to be included in financial report updates

Elevate any financial or quality concerns both domestically and globally to upper management

Train staff globally on financial management tools, contract development, risk management meetings and a variety of financial reports

Serve as a mentor to Safety Physician Coordinators on staying within budgeted hours and suggest contract modifications for Medical Monitor services, as needed

Departmental Lead contact for RFIs, Requests for Information, from potential clients.

Establish and maintain a global repository for frequently asked departmental questions for RFIs to include global metrics and global therapeutic experience

Assist team members with text for RFPs (Requests For Proposals) and contract modifications

Lead the annual, internal, global Safety Medical Management Plan audit to include developing the process, project list tracker, audit checklist template and evaluation form

Establish and maintain Medical Monitor Bid Defense tracker

Clinical Research Associate:

Performed and coordinated all aspects of the clinical monitoring process in accordance with GCPs and global SOPs

Conducted site visits to determine protocol and regulatory compliance, to include preparation of required documentation

Represented Clinical department in PQP meetings and protocol reviews for assigned projects

Developed collaborative relationships with investigative sites and client company personnel

Developed clinical database to include CRFs, DVM, CRF completion guidelines, MOP, laboratory manual and visit calendar for new protocols

Managed scheduling for onsite monitoring visits and site management calls in accordance with study specific monitoring plan for assigned sites

Provided education to sites/study staff on GCP/ICH regulations

Serious Adverse Event Coordinator:

Responsible for coordinating safety activities for standard noncomplex global/full development/multi-protocol studies, including budgeting, project set-up/close-out, preparation of project specific processes, SAE processing, narrative QC, SAE tracking, coding, reconciliation and identification of project resources needed

Performed SAE database set-up and user acceptance testing

Performed SAE database entry and quality review

Performed internal audit activities for departmental processes and procedures

Managed the regulatory reporting process for expedited events to ensure that accurate documents were submitted within the required timeframe to Sponsor, Investigator, regulatory authorities, etc.

Responsible for adhering to PPD’s corporate policies and SOPs/WPDs and assisting with the development, preparation and revision of department SOPs and WPDs and guidance

Effectively interfaced with project teams, client companies and investigators regarding SAE activities

Trained on the PVG budget and how to handle the hours allotted for each study

Mentored staff on standard SAE processing, study set-up/close-out and narrative generation

Assisted Care Home Health, Wilmington, NC

Patient Care Coordinator/Wound Care Nurse 2004

Case management activities for wound care patients

Sales and marketing in the community for home health services

Coordinated care and services for an easy transition for patients/caregivers from an acute care setting to home

Developed and implemented a wound care program

Consultant to physicians and other healthcare workers for wound care recommendations, including but not limited to wound assessment, nutritional assessment, topical therapies, support surfaces, and conservative sharp wound debridement

Educated staff, physicians and community regarding wound care

Assisted with implementing telehealth program

Wilmington Health Associates, Wilmington, NC

Colon and Rectal Nurse 1999-2004

Scheduled office appointments, colonoscopies, office surgeries and off-site surgeries

Triage RN for new, established, and postoperative patients

Assisted doctor as necessary with surgeries, procedures, and clerical work to include ICD-9 coding

Educated patients regarding ostomy care, colon and rectal cancer screening and pre-operative and post-operative instructions

New Hanover Regional Medical Center, Wilmington, NC

Charge Nurse 1996-1999

Responsible for nineteen patient capacity floor

Handled staff assignment of patients and narcotic control tasks

Responsible for resolving staff problems, emergencies and conflicts as needed

Cornelia Nixon Davis Health Care Center, Wilmington, NC

Staff and Charge Nurse 1995-1996

Responsible for a fifty-patient floor

Performed assessments and administered patient medications

Changed dressings and handled emergency care of assigned patients as required

Responsible for solving conflicts that arose among staff, patients and patient’s family members

LICENSES & CERTIFICATIONS

National Certified Public School Nurse, Mar 2015-Mar 2020

Certified Wound Care Nurse, Wound, Ostomy, Continence Nurses' Society, Jan 2005-Jan 2010

Registered Nurse, NC, Jul 1995-present

Certified Basic Life Support, annual certification last completed 2015

PROFESSIONAL AFFILIATIONS

Member of Wound Ostomy Continence Nurses Society (2005-present)

PROFESSIONAL DEVELOPMENT

Wound Care Specialty Education Program, 2004, Medical University of South Carolina, Charleston, SC

Entrepreneurial Mindset

2012-2019-Owned and operated an education consulting and management firm focused on delivering new learning solutions for schools and districts. Served as thought leader in the development of two charter schools in NC. Led the development of key health and nursing protocols and frameworks to ensure schools followed NC public school health guidelines.

Prior to Worldwide:

Chairperson of Geriatric Practice Council-Established visual acuity system

Helped develop standards of care for Geriatric Unit

Directed Pain Management Focus Study

Cambridge Who's Who

Graduated Magna Cum Laude

Honors Program at East Carolina University

Member of WOCN

Member of Sigma Theta Tau

Member of Phi Eta Sigma

Member of Phi Kappa Phi

Chancellor’s List

Dean’s List

National Dean’s List

COMPUTER EXPERIENCE

Windows, MS Word, Excel, Access, Internet, Netscape, Oracle AERS, Argus, SharePoint, Box, Salesforce, Veeva Vault, PowerPoint

CLINICAL TRIAL EXPERIENCE

CRA I:

Genitourinary: A Phase II Exploratory Study to Determine the Safety and Study the Immunomodulatory Functions of Induction Therapy With XXX, Combined with Chronic Immunosuppression with XXX and XXX

Genitourinary: A Randomized, Multi-Center Comparative Trial of XXX with Steroids and Standard XXX Induction versus a Novel Steroid-Free XXX Based Immunosuppression Protocol with Extended XXX Induction in Pediatric Renal Transplantation

Genitourinary: B-Cell Depletion by XXX in Renal Allograft Recipients who Develop de novo Anti-HLA Alloantibodies will Result in inhibition of Alloantibody Production and Attenuation of Chronic Humoral Rejection

Genitourinary: Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

Circulatory System: Observational Study of Alloimmunity in Cardiac Transplant Recipients

Circulatory/Digestive System: Correlation of Donor Proinflammatory mRNA Profiles with Early Outcomes of Thoracic and Abdominal Transplantation

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