Clinical Research Coordinator MBA/MHCM

SHERONDA D. BROWN

**** ****** **** *****

Frederick, MD 21703

Home: 301-***-****

Cell: 240-***-****

***********@*****.***

OBJECTIVE

To apply my clinical research experience, education, and skill set in a progressive organization, which constitutes opportunities for continuous professional development. To apply experience gained from coordinating Phase II-IIIb clinical trials, execution and control of late phase/registry/prospective programs with specific concentration on managing participating sites of ensured study success, including the maintenance of financial reporting for successful growth of expenses and allocated required expenses. Unique management experience based approach of clinical project assistants and associates of eight or more people. To apply my quality assurance coordinating skills in accordance with JCAHO in assuring all medical data or additional responsibilities are essential and met in accordance with GCP and SOP guidelines. Manage specialty plasma programs and is responsible to assist the center manager in the overall activities, as designed by the center manager, required to meet corporate short and long term operational objectives. Compliance with Regulatory and Corporate policies and procedures that is essential to ensure donor and employee product safety.

EMPLOYMENT HISTORY

05/2011- 07/2011 In-House CRA, Technical Resources International, Inc. Bethesda, MD

(Government Contractor)

• Review essential regulatory documents for accuracy and completeness as required by FDA-GCP, ICH-E6, Sponsor’s requirement and SOPs.

• Essential regulatory document collection, tracking, and transmittal.

• Adherence to strict project timelines & expectations.

• Multi-task in the processing and preparation of essential regulatory documentation

• Troubleshoot document issues by applying existing knowledge to solve new problems

Reason for leaving: Government contract assignment for data clean-up was completed.

11/2010 – 04/2011 Specialty IND/ Program Manager, Cangene Plasma Center, Frederick, MD

• Manage Specialty plasma programs

• Maintain donor and product safety

• Maintain files and adherence to customer specifications and procedures

• Aid in recruitment initiatives

• Welcome and orient new donors to the center

• Facilitate donor schedules and appointments

• Listen to donor, employee and physicians concerns and take action as appropriate

• Effectively communicate, work with, and relate to people.

• Promote teamwork and positive, professional relations with staff and donors

• Ability to motivate, educate and coordinate with others

• Posse strong oral and written communication skills

• Have through and accurate knowledge, and able to apply FDA, CLIA, QPP, cGMP and state/local

regulatory requirements

• Remain current with all local/state/federal, and international regulations and understand

implications for the centers operations

• Remain current with all program specific requirements

• Operates in the capacity of a Physician Sub and/or Donor Tech, as applicable and as directed by

the Center Manager.

• Maintain and monitor infection control for the center/ medical device company in Canada

• Monitor the condition of the center environment (physical plant) and resolve any concerns

Reason for leaving: I was laid off due to grant funding for continuing studies to be ran at this

facility.

12/2008 – 11/2010 Clinical Research Coordinator, Children’s National Medical Center, Washington DC

• Independently oversee research study operations, which may include supervising and engaging in the following activities; data collection through patient enrollment, patient or family interviews, medical chart abstraction or other methods, data entry, budget keeping, report preparation, presentation preparation, IRB preparation, and other administrative duties. The Clinical Research Coordinator/Senior Clinical Research Coordinator works largely independently with minimal supervision and may have supervisory duties for other staff team members.

• Ensure creation of the site-specific documents such as informed consent and subject information sheet.

• Provide internal study documents such as project plan, monitoring guidelines, protocol manual and CRF completion guidelines, which includes the review or writing of a draft/follow-up of finalization of documents.

• Ensure appropriate trial related documents are selected for use during the study and that these forms are adequately completed accordingly

• Manage IRB/IEC submissions

• Attend Investigator meetings as required and assist in organization of the meeting or present topics as required.

• Perform feasibility studies

• Chart Abstraction data collection for protocol requirements

• Gained experience working in conjunction with pharmaceutical sponsors: National Institution of Health in the Government/ NHLBI/CRO industry experience

• Perform trial follow-up and administration of adequate filing of all related documents, both hard and electronic copies. Complete study specific forms and track all activities from the investigator sites. Ensure management of all incoming and outgoing safety information in a timely manner. In-house management of all investigational product and study supplies, also archival of TMF files returned back to the sponsor.

• Worked alongside with Oncology staff members for sample taking, vital signs, administering medication and ensuring medication safety for each subjects recorded visit. Tracked all samples accordingly in the EDC system for sample results for each charted visit and recording were made on CRF’s for each visit.

• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation

• Provides functional guidance and regulatory training related to the collection and review of essential regulatory documents (IND, CSR, license requirements, etc.).

• Collects study specific regulatory documents (Form 1572, financial disclosure forms, and protocol signature pages) from participating research sites. Quality checks documents and escalates as needed

• Audit assist during audits and follow-up occurrences accordingly.

• Act as a primary coach, undertaking site visits accompanied with associated monitoring experiences.

Reason for leaving: Presented with a new career opportunity in management.

07/2008 - 11/2008 Site Manager & Monitor, SGS Life Sciences Services, Gaithersburg, MD

(Contractor)

• Assist Head Clinical Operations/ Head of Division/ Project Manager

• Perform and organize coordination, administrative management, monitoring and site management of national and international clinical trials (phase I-IV) according to ICH-GCP, EU CTD or FDA CFR21.

• Independently prepare and perform Investigator site visits relevant to the phase of the study selection and qualification, initiation, regular monitoring or site closure as specified in the project plan and monitoring guidelines. Ensure compliance of the trial conduct with the protocol and applicable guidelines and regulations.

• Gained experience working in conjunction with pharmaceutical sponsors: Astra Zeneca, Johnson & Johnson and Abbott Labs in the pharmaceutical/CRO industry experience.

• Manage trial documentation

• Write or review patient documents (informed consent, subject information, clinical study protocol, CRF and trial related financial as delegated by the Project Manager

• Ensure creation of the site-specific documents such as informed consent and subject information sheet.

• Provide internal study documents such as project plan, monitoring guidelines, protocol manual and CRF completion guidelines, which includes the review or writing of a draft/follow-up of finalization of documents.

• Ensure appropriate trial related documents are selected for use during the study and that these forms are adequately completed accordingly.

• Manage IRB/IEC submissions

• Attend Investigator meetings as required and assist in organization of the meeting or present topics as required.

• Perform feasibility studies

• Perform trial follow-up and administration of adequate filing of all related documents, both hard and electronic copies. Complete study specific forms and track all activities from the investigator sites. Ensure management of all incoming and outgoing safety information in a timely manner.

• In-house management of all investigational product and study supplies, also archival of TMF files returned back to the sponsor.

• Collects study specific regulatory documents (Form 1572, financial disclosure forms, and protocol signature pages) from participating research sites. Quality checks documents and escalates as needed.

• Audit assist during audits and follow-up occurrences accordingly.

• Act as a primary coach, undertaking site visits accompanied with associated monitoring experiences.

Reason for leaving: Contract assignment for data clean-up and site monitoring was completed with close-out visits and data analysis for assigned sites.

02/2008 - 05/2008 Project Research Associate, I3 Innovus, Reston, VA (Contract)

• Assists with the implementation of studies under the direction of senior staff.

• Assists in the recruitment and qualification of study sites.

• Performs or collaborates in the training of sites on study protocol, guidelines, operations, and data submission.

• Assist with the development of study materials, which may include protocol, questionnaires, case report forms, consent forms, newsletters, reports, etc.

• Act as primary liaison with participating sites to convey project information and answer questions, troubleshoot, advise, and follow-up on study progress with sites.

• Collects study specific regulatory documents (Form 1572, financial disclosure forms, protocol signature pages) from participating research sites. Quality checks documents and escalates as needed.

• Performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the

• Safety and efficacy of investigational products and/or medical devices.

• Conducts site visit to determine protocol and regulatory compliance, and prepares required documentation.

• Performing monitoring visits including site qualification, initiation, monitoring and closeout visits; developing monitoring plan; maintaining contact with study sites, report preparation and communications documentation; conducting training; preparing for and participating in Sponsor and FDA audits; managing clinical project assistants and associates.

• Gained experience working in conjunction with pharmaceutical sponsors: GlaxoSmithKline and Baxter in the industry experience.

Reason for leaving: Contract assignment for site initiating and feasibility

data gathering for new initiated sites and data analysis gathering for incomplete budget

contracts.

11/1999 - 01/2008 Lead Clinical Research Associate, The Cleveland Clinic Foundation,

Cleveland, OH

• Coordination of various clinical trials that includes chart abstraction and data collection/organization and adherence to protocol requirements.

• Perform specific project related tasks, i.e. responds to spreadsheets which monitor study database source, transfer of data management reports and assist in obtaining regulatory documents.

• Gained experience working in conjunction with medical device companies: Teva, Roche, Bristol Meyers Squibb, Par-Pharmaceutical, Merck &Co, Eli Lilly, Pfizer, and Covance in the pharmaceutical physician/CRO industry experience.

• Adherence to study project specifics per sponsor SOPs and verification plan in accordance with FDA agreement.

• Assist with the financial department to ensure accurate timely payments and monitoring for clinical trials.

• Participate in ongoing meeting investigator meetings of FDA requirements.

• Participated in IRB submission and protocol ICF, Informed consents and submitting data for supplementary documents for IRB submission review.

• Familiar with FDA regulations and guidelines/forms and IRB standards.

• Participate in team meetings and weekly teleconference call meetings.

• Participated in areas of recruitment, employment training and process of hiring and termination process.

• In conjunction of the working areas, supervised seven staff members.

• Compliance oversight of clinical trials to ensure integrity of data and information.

• Coordination and participation in Sponsor/Monitor/International Meetings (on and off site/telephone/video).

• Participated in ongoing Clinical Events Committee meeting for overall study reviews, updates and new study requirements.

• Coordination of CEC data and readings of ECG and accordance with study specifics for each clinical trial.

• Maintained all CEC data and data submission to the IRB adherence to the study and for all monitoring purposes of the trial.

• Maintained financial reports, and statistics of trial studies. Implement tracking system for all study related cites and data management support.

• Perform data verification of all source documents and data checks (lab results and adverse events for the clinical studies.

• Ensured the review and completion, collection, and submission of regulatory documents/status.

• Kept accurate documentation (telephone memos, site correspondence, etc) related to the clinical trial issues, including outstanding data.

• Participated in the development and maintenance of study project databases start-up systems.

• Performed source document test material accountability, study supply, and material tracking.

• Prepare a variety of reports, documents and correspondence for regulatory agencies, participating clinical trials sites and internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress.

• Creates audit reports

• Follows up on audit corrective actions

• Conducts process data audits

• Conducts system file audits

• Collects data

• Tracks projects

• Reports on projects

• Performing monitoring visits including site qualification, initiation, monitoring and closeout visits 75% traveling; developing monitoring plan; maintaining contact with study sites, report preparation and communications documentation; conducting training; preparing for and participating in Sponsor and FDA audits; managing clinical project assistants and associates.

Reason for leaving: Presented with a challenged to relocate and work in other therapeutic areas that allowed me a diversified research experience.

10/1997 - 11/1999 Customer Service Representative, The Cleveland Clinic Foundation,

Cleveland, Ohio

• Supervised support staff in Laboratory Medicine

• Responsible for all aspects of training and education of support staff.

• Developed and implemented data collection tools for clinical study projects.

• Responsible of data reporting and analysis.

07/1995 – 10/1997 Patient Care Technician, The Cleveland Clinic Foundation, Cleveland, Ohio

• Responsible for performing EKG’s, patient and bed assistance, and blood draws.

• Special training in telemetry and special assignments per nursing floor criteria.

• Other special skills include training technicians and floating to assist in various clinical areas of the hospital.

05/1998 – 06/2005 Lab Technician, Phlebotomy Specialists, Shaker Hts. Ohio

• Responsible for supervising and training lab technicians.

• Developed departmental education programs.

• Issue and Resolve data queries

• Clinical expertise includes resolving patient related problems/concerns as identified by self and office manager

• Process and allocation of various types of laboratory specimens

• Worked closely with various clinical trials areas, to obtain various laboratory patient statistics and laboratory supplies for studies.

• Generate detailed utilization management reports

02/2006 – 01/2008 Lab Technician (Part-time), University Hospitals, Bedford Hts. Ohio

• Responsible for supervising and training lab technicians.

• Developed and implemented lab protocols.

• Developed and implemented data collection tools.

• Responsible for data reporting and analysis.

• Process and allocation of various types of laboratory specimens

• Clinical expertise includes resolving patient related problems/concerns as identified by self and office manager

THERAPEUTIC EXPERIENCE

• Cardiovascular Medicine

• Women’s Health

• Nutrition

• Special Lab Studies Device

• Birth Control

• Atopic Dermatitis

• Acid Reflux (Gerd)

• Hematology/Oncology

• Sickle Cell

• HIV

• Hepatitis Vaccine Booster

• Infectious Disease

• PK

• IND & NON IND

PUBLICATIONS

Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14; 376(9740):489-90.

Deepika S. Darbari, Onyinye Onyekwere, Mehdi Nouraie, Caterina P. Minniti, Lori Luchtman-Jones, Sohail Rana, Craig Sable, Gregory Ensing, Niti Dham, Andrew Campbell, Manuel Arteta , Mark Gladwin, Oswaldo Castro, James G. Taylor, Gregory J. Kato, Victor R. Gordeuk; PUSH Investigators. Pulmonary Hypertension Research Study. 2011 Journal Pediatrics.

EDUCATION

PhD Program - Doctor of Management in Organizational Leadership (EDD), University of Phoenix, Phoenix, AZ, Present

Certification – Program Management Certificate, University of Phoenix, Phoenix, AZ, 2008

MBA and Masters in Health Care Management, University of Phoenix, Phoenix, AZ, 2007

BS, Health Care Administration, University of Phoenix, Phoenix, AZ, 2005

AA, Cuyahoga Community College, Cleveland, OH, 2004

Certification – Phlebotomy Technician, Lakeland Community College, Kirtland, OH

COMPUTER SKILLS

Microsoft Office-Word, Excel, Access, Power Point, Epic System (Oracle data base), Lawson, C-Star, Sunquest, Pre-Cis, Rho-Systems, Access oracle data base

INTERESTS

• Member of the Cleveland Black Nurses Association. Volunteer activities include participation in the Welcome Committee, Events Committee and Leadership Development.

• Continuing Education courses in health care leadership programs.

• Mentor – high school affiliation programs

• Member of the International Biopharmaceutical Association.

• A voice in developing responses to industry issues and challenges.

• Mentioning of our affiliation with IPBA in / business communications which will increase reliability of professional profiles in the global market.

REFERENCES

Available upon request

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