Clinical Research Data Entry

Chioma Christine Amartey

Philadelphia, PA ***** 215-***-**** ad5cid@r.postjobfree.com

Profile

Detail oriented and experienced professional passionate about data management, science, and genetics. Friendly and engaging team player and leader able to inspire staff to perform at their best. A multi-tasker who excels at driving tasks to completion and willing to work in a fast-paced environment with cross functional teams.

Experience

CLINICAL RESEARCH COORDINATOR UNIVERSITY OF PENNSYLVANIA PHILADELPHIA, PA OCTOBER 2019 - PRESENT

· Support ongoing allocated studies with data operations

· Manage query resolution, data entry, source documentation, identification of SAEs and completion of SAE forms submitted within protocol specific deadlines

· Utilize electronic data capture (EDC) via Medidata Rave, CRMS, Veeva and LabVantage for various oncology clinical trials and maintain multiple data sets, metrics and facilitate data collection in coordination with principal investigator, statistician, clinical teams, and study teams

· Submit request for RECIST (Response Evaluation Criteria in Solid Tumors) reports

· Support full cycle of clinical studies from study start-up, treatment phase, study completion, study closure, data lock and publication

· Create and maintained laboratory manuals for Investigator Initiated trials (IIT) and assist with CRF build and clinical trial protocol development

· Develop and maintain SOPs and template documents

· Collaborate with monitors, CROs and pharma companies (i.e. BMS, GSK, Precision for Medicine, Merus, HiberCell)

· Work collaboratively with cross-functional teams such as Regulatory Affairs, Business Offices Biospecimen Labs, Radiology, Pathology Labs, Whole Exome Lab, and Office of Clinical Research (OCR) to ensure compliance and completion of data deliverables

· Train and onboard new clinical research coordinators

· Manage weekly patient calendars and office visits

· Reduce costs by increasing operational efficiencies, and reduced waste.

· Conduct clinical research activities in accordance with Good Clinical Practice (GCP) guidelines DATA ANALYST I CHILDREN’S HOSPITAL OF PHILADELPHIA (CHOP) - DIVISION OF GENOMIC DIAGNOSTICS PHILADELPHIA, PA AUGUST 2016 – OCTOBER 2019

· Established Data Usage Agreements (DUAs) and Material Transfer Agreements (MTAs) with collaborating facilities.

· Coordinated the release of raw exome data and sanger sequencing raw data

· Facilitated communication with physicians, outreach clients and clinical staff

· Conducted data entry into various patient databases (FileMaker Pro, Micro Array Molecular Portal, SoftLab, Meditech)

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· Documented any errors/events that directly or indirectly affect patients, by entering details into the hospital safety reporting system, referred to as (KAPS) Keeping All People Safe.

· Reviewed research IRB protocols and HIPAA consents for requests to release raw data and sample release requests.

· Updated official genetic test requisition forms

· Created job aids and SOPs for inter-laboratory use and new staff training

· Performed test utilization, by accessing Electronic Medical Record (EMR), reviewing clinical indication and determining appropriateness of test orders.

· Performed tracking and recording of all STAT and URGENT test orders and relaying pertinent details each morning during Department Laboratory Huddle

CLINICAL LABORATORY TECHNICIAN I - CLIENT SERVICES CHILDREN’S HOSPITAL OF PHILADELPHIA (CHOP) PATHOLOGY AND LABORATORY MEDICINE PHILADELPHIA, PA AUGUST 2013 – AUGUST 2016

· Performed Clinical Quality Improvement (CQI) activities to contribute to increasing patient safety

· Compiled CQI reports and presented at monthly CQI meetings

· Received, review and entered patient result reports

· Notified clinicians of critical test results, test cancellations due to insufficient quantities of samples, and delays

· Provided/updated test information concerning specimen requirements, stability, and pricing of reference laboratory tests.

· Facilitated ordering, processing, and submission of add-on test requests for samples at

· reference laboratories

· Interacted with co-workers, visitors, physicians, genetic counselors, and other clinicians consistent with the hospital core values.

· Promptly responded to, resolved, and followed up with all clinical issues related to the Central Labs of the Pathology and Laboratory Medicine Department.

· Performed detailed data entry in the Laboratory Information System (LIMS)

· Received/managed all calls for the Chemistry, Hematology and Main Central Laboratories via the inContact ® telecommunications software.

MARKETING DIRECTOR SOCIETY FOR FINANCIAL AWARENESS (SOFA)/AMERICAN PROSPERITY GROUP BRYN MAWR, PA AUGUST 2006 – MAY 2013

· Established working business relationships with businesses and non-profit organizations

· Conducted effective marketing strategies via arrangement of seminars, workshops, presentations and events regarding Financial Awareness, Estate Planning, Long-Term Care, Forces of Portfolio Demise, Maximizing Retirement Income, Health and Wellness, Life Insurance Options, and Social Security Planning

· Scheduled financial workshops

· Created, edited, and updated financial presentations

· Arranged meetings, agendas, and client files

· Conducted appropriate/secure handling of sensitive material, information, and financial statements

· Organized all office administration

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· Opened, set-up and closed office daily

· Arranged placing of office supplies orders

· Managed scheduled workshop calendar, scheduled client appointments, handled majority of office correspondence (emails, faxes, outgoing & incoming mail)

· Coordinated and organized all in office operations.

· Trained newly hired office associates

· Developed and maintained client relations

RESEARCH LABORATORY TECHNICIAN CHILDREN’S HOSPITAL OF PHILADELPHIA (CHOP) CENTER FOR APPLIED GENOMICS UNIVERSITY CITY APRIL 2004 – SEPTEMBER 2007

· Conducted various studies using single nucleotide polymorphism (SNP) based Whole Genome Wide Association to identify the biological pathways for disease development

· Performed DNA quantification, amplification (PCR), fragmentation, precipitation, as well as DNA hybridization to Illumina® bead chips containing up to 550,000 SNPs for sequencing

· Studied the genetic linkage to various diseases such as Asthma, Neuroblastoma, ADHD, Epilepsy, Autism, Crohn’s Disease, and Type 1 Diabetes to identify specific genes that are responsible for these diseases

· Disease studies of Crohn’s Disease as well as Type 1 Diabetes resulted in significant published results in Nature magazine

· Use of automated, protocol installed, Illumina Tecan Robot technology

· Experience in high throughput environments via 264 patient samples processed in a day using Illumina

® Beadlab genotyping platform

Education

ROSEMONT COLLEGE – ROSEMONT, PA

Field of Study: Biology

Coursework: Cell Biology, Molecular Genetics, Life Science & Laboratory, General Chemistry, Immunology, Organic Chemistry, Molecular, Anatomy and Physiology, Physics, Medical Spanish, Microbiology, Social Problems Skills & Abilities

· Proficient with Microsoft Office

· Detail oriented

· Experience with data management plans and

clinical trials software

· Experienced with leadership and training

· Excellent communication and organizational skills

· Ability and willingness to learn and develop new skills

· Familiar with EMRs such as EPIC, Meditech

· Strong critical thinking and analytical skills

· Adaptability

· Poised under pressure

· Experienced with GCP and ICH guidelines

· Knowledgeable in cancer biology

· Experience in a regulated industry environment

· High level of initiative and ability to work

independently

· Experience with Phae 1 and Phase 1/B Clinical

Trials

· Knowledge in Pancreatic Cancer, genomics,

Homologous recombination deficiencies (HRD)

and PARP inhibitors

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Volunteer Activities

LUTHERAN SETTLEMENT HOUSE FOR WOMEN AND CHILDREN

Organized food drive, winter coat collections, donations, and assisted in repairs to the Lutheran settlement house and affiliated shelter Jane Addams Place CAMPUS WOMEN FOR CHRIST ANNUAL FOOD DRIVE

Set up designated locations and organized nonperishable food collections NEIGHBORHOOD ASSISTANCE COORPORATION OF AMERICA (NACA) Assisted first-time home buyers with information and steps to purchase a home without any closing costs required, down-payment required, nor mortgage insurance required. Aided first time home buyers on how to maintain financial stability after home ownership.

REACH GOSPEL RADIO

Assisted with the prayer ministry by receiving prayer requests and offering prayer for individuals who called in need of prayer.

Publications

· CHOP 2006 Research Annual Report Scientific Discovery to Medical Innovation

· Results extending from extensive research performed in the Center for Applied Genomics (CAG) of The Children's Hospital of Philadelphia (CHOP) resulted in numerous publications.

· Joseph Stokes Jr. Research Institute. The Children's Hospital of Philadelphia. Research Annual Report. Discover to Medical Innovation. 2006. pp. 2-4

https://www.research.chop.edu/themes/custom/chopresearch/pdfs/annual_report_2006_Reduced.pd f

· Hakonarson H, Qu H, Bradfield JP, Marchand L, Kim CE, Glessner JT, Grabs R, Casalunovo T, Taback SP, Frackelton EC, Eckert AW, Annaiah K, Lawson ML, Otieno FG, Santa E, Shaner JL, Smith RM, Onyiah CC, Skraban R, Chiavacci RM, Robinson LJ, Stanley CA, Kirsch SE, Devoto M, Monos DS, Grant SFA, Polychronakos C. A novel susceptibility locus for type 1 diabetes on Chr12q13 identified by a genome- wide association study. Diabetes. 2008. 10(2337): db07-1305.

· Genome Res. 2009 September; 19(9): 1682–1690. Hakon Hakonarson, Chioma C. Onyiah, Svetlana Ostapenko, F. George Otieno, Erin Santa, Julie L. Shaner, Robert Skraban, Ryan M. Smith, Josephine Elia, Elizabeth Goldmuntz, Nancy B. Spinner, Elaine H. Zackai, Rosetta M. Chiavacci, Robert Grundmeier, Eric F. Rappaport, Struan F.A. Grant, Peter S. White. High- resolution mapping and analysis of copy number variations in the human genome: A data resource for clinical and research applications https://genome.cshlp.org/content/19/9/1682.short

· Niraparib plus nivolumab or niraparib plus ipilimumab in patients with platinum-sensitive advanced pancreatic cancer: a randomized, phase 1b/2 trial

· Kim A Reiss 1, Rosemarie Mick 2, Ursina Teitelbaum 3, Mark O'Hara 3, Charles Schneider 3, Ryan Massa 3, Thomas Karasic 3, Rashmi Tondon 4, Chioma Onyiah 3, Mary Kate Gosselin 3, Alyssa Donze 3, Susan M Domchek 3, Robert H Vonderheide 3 PMID: 35810751 PMCID: PMC9339497 DOI: 10.1016/S1470- 2045(22)00369-2. https://pubmed.ncbi.nlm.nih.gov/35810751/

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