Willing to travel to any location as needed.

Experience

University of Missouri- Clinical Trials- Hem/Oncology Columbia, MO Jan 2015- Aug 2022

Clinical Research Professional / Coordinator Protocol Services

nData Management

oEnsure accurate and timely data collection, aggregation, documentation, data entry, data reporting, and query resolution on both active treatment and long-term follow-up patients.

oIdentified problems and/or inconsistencies and monitored participant's progress to include documentation and reporting of adverse events and serious adverse events.

oManage the progress of assigned studies by tracking regulatory submissions and approvals, and enrollment in PowerTrials.

oDesign and develop source documentation for oncology clinical trials, in accordance with protocol specific requirements, to ensure institutional compliance.

oEvaluates incoming patient data for protocol and procedural compliance

Assists with the enrollment and/or randomization of research participants

Initiates and maintains open communications with research institutions through oral, written, and electronic methods to ensure compliance with protocols and overall study objectives

oCollect and process whole blood samples, PK samples, serum, Buffy Coat and plasma markers, and tumor tissue slides/specimens.

nIRB

oDeveloped new processes for submitting monthly IND Safety Reports.

oResponsible for submissions of Investigator’s brochures, revised protocol updates, Amendments, and Data Safety Monitor Board (DSMB) documents to IRB and maintaining IRB approvals.

oPerform Central IRB submissions on behalf of sponsors and sites as agreed to in the scope.

oKnowledgeable on the process of informed consent per FDA guidelines.

oAssist with informed consent form (ICF) modifications from sites per sponsor and site requirements for all types of consent forms used during each study (pharmacokinetics [PK], pharmacodynamics [PD], pharmacogenomics [PG], HIPAA, etc).

oUpload and process all correct and complete study documentation for the purpose of study startup and study specific TMF system whether electronic or paper.

nAssist with development of Standard Operating Procedures (SOPs) and review CRF/DCF data according to SOPs as well as study protocols.

nRegulatory Functions

oManage older protocols for accuracy of funding from sponsors, and reconcile site invoices with completed patient procedures.

oEstablish regular lines of communication with sites to manage ongoing project expectations and issues. Ability to build effective relationships within a cross-functional team environment with a high level of professionalism.

oComplete, facilitate, and maintain essential regulatory documentation including collecting, processing, and maintaining study start-up, staff licensure, CVs, training records required for clinical research compliance for proposed and active research projects and study close-out. Interact with study teams, site personnel, sponsors, to facilitate timely collection, and processing of essential Reg documentation ( 1572, FDF’s, Signature pages, Reg study binders, training logs with signatures) and to provide ongoing status reports about the documentation.

nParticipates in and facilitates training in workshops as relevant.

nCompletes routine data management tasks

oKnowledge of medical terminology

oGood understanding of ICH/GCP guidelines

oProficient with different EDC systems (Alliance, Rave- iMedidata, NSABP, SWOG,)

oExcellent written and oral communication skills

oCompetent in Microsoft Office including Excel, Word, PowerPoint and Outlook

oExcellent interpersonal/teamwork skills for effective collaboration

oExperience working with commercial EDC software (e.g. ABBVIE 3005 Rave, MARVIN, Oracle)

nSpecialized training

oICH/GCP certified January 2021 (CITI Program transcript available upon request)

oRave, NSABP, CTEP, Virtualscopics, REDCap, CTMS, eTMS systems

oIATA Biospecimen training

Columbia Homestead INC Columbia, MO September 2018 – May 2022

CEO/CFO

nOutsourced to 3rd party management in 2022, still providing project oversight.

nOversaw and actively managed 100 residential rental units owned by family investment group.

nExperience leading multidisciplinary teams.

nConducted periodic performance reviews with all direct reports in accordance with company policies

nExperience in conducting internal banking audits, system and process audits in accordance to investors/tenants requirements.

nManaged all financial transactions, including accounts payable/receivable, maintenance expense budgeting, and financial reporting/taxes.

nManaged all customer services support functions.

University of Missouri Dermatology- MOHS Surgery Clinic Columbia, MO July 2011 – Jan 2015

Patient Service Representative

nSchedule provider appointments and coordinate ancillary testing.

nPrepare accurate billing documents.

nVerify Insurance Authorizations and Patient Demographics in compliance with HIPPA regulations.

nCollect payments; Reconcile and total daily cash payment batches for the office and prepare deposits for the bank.

nAnswer phones and dispatch calls to appropriate areas.

nUse EMR, Cerner IDX and PowerChart software to perform the above duties.

nExperienced in training new staff in current positions to use UMHC Cerner EMR, Cerner IDX, Powerchart and E-Signature.

nMember of the clinic's Quality Improvement Team and Work Sheet Team.

Preferred Family Health-Care Jefferson City, MO June 2009 – Jan 2010

Rehab Tech

nResponsible for the needs of individuals with substance abuse issues.

oAdhered to assigned treatment schedules and provided feedback on rehabilitation.

oPrepared the treatment areas.

oProvided leadership and supervision to the client population.

nJob skills included: being an effective listener to client problems, finding solutions, facilitating education, coordinating group activities and providing educational programs to rehabilitate troubled adolescents.

nTrained in CPR, First Aid and administering prescription medicines to patients.

YMCA Child Development Center Jefferson City, MO October 2008 - March 2009

Pre-K Teacher- Floater

nInvolved children in their environment with activities to build and develop social, emotional, cognitive, language, and gross and fine motor skills.

nIntroduced activities that were not only developmentally appropriate for children but meaningful as well, including various hands-on activities. An important part of the daily schedule was to foster independence.

Edmonton Neuro-Cognitive Rehabilitation Ltd Edmonton, Alberta Canada May 2003 - February 2007

Assistant/Office Manager

nProvide functional leadership and serve as primary liaison between provider and internal/external patients.

nSupervise staff and manage performance reviews.

nExperience in conducting GCP provider site audits, systems audit, process audits and regulatory audits.

nAssisted in handling budgeting and payroll for office staff.

nCoordinated all aspects of Director’s meetings, calendar, conference and overseas travel.

nTrained staff to use different applications related to their job duties.

nMonitored/recorded patient progress, and behavioral changes. Organized/ supervised group activities within the community.

nScheduled appointments and billings, filed material for future reference, edited documents and case histories, implemented safety regulations and appropriate policies and procedures, and other administrative duties.

T.D Canada Trust Edmonton, Alberta Canada June 2003 – May 2004

Easyline Specialist (Sales and Services)

nProvided customer service for incoming contact center clients. Identified all sales opportunities and offered clients a full range of products and services to meet their needs via phone.

nJob skills included customer service and sales, promoting products/services, excellent listening and communication skills, ability to multi task and work independently, organization and time management skills and analyzing customer needs and resolving customer concerns.

nAwarded for selling the most saving accounts and guaranteed investment certificates.

Education

Moberly Area Community College, Columbia, MO 2011-2014

Prerequisites toward a Bachelor’s of Science in Nursing

R.D National College, Bandra, Bombay, India. 1995-2000

Major- Bachelor of Arts in Economics

Minor- Psychology, French, Mass Communication and English Literature

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