Manager

Reginya V. Knight, B.S., M.B.A.

**** ******* ****** **. ******* TX 77433 832-***-**** *************@*****.***

OBJECTIVE

To be an employee that makes significant contributions that will lead to company profitability and personal career growth.

COMPUTER SKILLS AND OTHER TRAINING

Microsoft Word, Excel, and Power Point

Knowledge of Epic inpatient and outpatient

Skilled in programming and troubleshooting of Biomek 2000, Spectramax 190, and Multimek.

Perform PCR, process cDNA, DNA hybridization, and gel electrophoresis

Manage/coordinate clinical trials including Phase 1 (bioequivalence) through 4 and investigator-initiated trials

Familiar with CBT 4 and ICD 9 codes

Experience with preparing for audits and monitoring by CROs

Verify source data/documents, e-signatures on CRFs and digital documents, and ensuring other trial records are accurate, complete, and maintained

Knowledge of ICH Good Clinical Practices regulations and 21 CFR 312 regulations for conduct of clinical trials.

Maintain TMFs (Trial Master Files) and other regulatory items (1572, training logs, etc) for Sponsors and CROs

Review source documents, drug accountability, reviewing/reporting SAEs and AEs, toxicity reports, concomitant medications, and identifying data discrepancies (queries)

Review drug (or device) accountability, tracking records, and clinical research pharmacy processes

ACRP or SOCRA eligible

PROFESSIONAL EXPERIENCE

Baylor College of Medicine

Senior Research Coordinator 2015 - Present

Coordinate and participate in clinical research studies conducted by principal investigator(s) in the Department of Surgery, including studies that range from investigator initiated trials to Phase 1 to Phase 4 including medical devices

Prepares and submits IRB and other regulatory documents

Enrolls and consents patients to participate in studies

Receives tissue specimens in operating room

Coordinates completion of research projects – assigns tasks, sets deadlines, and monitors progress.

Maintains database for research projects

Edits abstracts and manuscripts

Writes drafts of abstracts, syllabi, manuscripts, grants, posters – assures timely submission

Maintains regulatory approvals for research projects

Obtains BCM Office of Research approval for grant submissions (via BRAIN)

Maintains institutional compliance, including documentation, for studies (signed consent forms, etc.)

Assists with complete of grant progress reports

Explores funding opportunities

Novum Pharmaceutical Research Services

Study Manager/Clinical Research Coordinator 2013 - 2015

Work with source document staff on development and QC of study specific documents.

Coordinate initiation meeting with all pertinent staff e.g., Recruiting, Screening, Source Documentation, Maintenance, Pharmacy, Quality Assurance, etc. prior to study start.

Review clinic schedule for adequate staff coverage of all protocol activities and communicate any concerns to Clinic Manager.

Consult with Pharmacy Technician for drug handling, dispensing, dosing time and dosing intervals.

Review sample collection and processing instructions with Phlebotomists to ensure all requirements are followed.

Work with Screening Department to ensure participants meet all eligibility criteria.

Participate in dosing of study participants.

Record any adverse events (AE) and discuss with Investigator as appropriate. For each study period prepare adverse event summary for Client Services.

Hire, Schedule, Supervise and discipline (as necessary) all Research Associates, Technicians and Phlebotomists assigned to the study. Communicate all staff issues to management for appropriate follow up.

Orient and train new staff as applicable.

Verify documentation of all study activities.

Assign case report form completion to appropriate staff.

QC all case report forms for accuracy within specified time frame.

Compute participant payments based on completed study participation.

SeqWright Inc. Quality Assurance/EHS Specialist 2012 - 13

Administer health, safety and environmental program

Supervise EHS policies and aide as consultant

Gather and report EHS data

Provide technical guidance and support coordination regarding various safety issues

Administer joint safety committee

SeqWright Inc. Quality Assurance Associate 2008 - 13

Responsible for internal auditing of regulated projects, general facilities, employee training records, equipment qualifications, and environmental monitoring

Complete CAPA’s where analysis of situation or data requires a review of identifiable factors

Analyze, build, and maintain site-specific content primarily related to research and clinical trials

Works with Research and Development team, Quality and FDA Clinical groups

Test content built by bioinformatics department and document results

Perform compliance audits and maintain accurate records

Develop and implement protocols to meet FDA and CLIA compliance programs

Assist with process quality team in terms of development and quality control plans

Maintain and manage internal audit plans

Cogenics Associate Scientist II 2007 - 08

Performed laboratory tasks necessary for the successful and timely completion of QPCR projects

Reviewed projects for FDA regulatory submission in compliance with GLP and cGMP regulations, study protocols, standard operating procedures, data visualization, spreadsheets, database, and other controlled document

Monitored host DNA, plasmid DNA, DNA and RNA purification

Screened candidates, and coordinated interviews

Lexicon Genetics Research Associate 2002 - 07

Maintained a high-throughput mouse production via high space utilization and breeding efficiency for assigned projects in a biopharmaceutical company

Coordinated and performed necessary mouse manipulation techniques such as tail biopsies for genotyping

Monitored and reported all abnormalities and phenotypes

Responsible for project management, tracking of assigned projects, troubleshooting problem projects, and for high throughput mouse production for all level 2 breeding projects assigned

In the genotyping group, performed bookkeeping, time management, data analysis, preparation of buffers and stock solutions, PCR and QPCR duties using the 7900HT and Biomek to produce data

Genometrix Inc. Production Associate III 1999 - 01

Printed DNA micro arrays in an ISO 9000 class c1000 clean room environment with primary emphasis on GMP and GLP

Helped to ensure 100% adherence to all safety procedures during testing of instrumentation and proper procedures for handling hazardous materials

Implemented automated process of oligonucleotide QC

Created Standard Operating Procedures for oligonucleotides and print plate assembly

Responsible for all daily operations in this lab including management of a team of technicians

Trained employees in oligonucleotide QC processing

Skilled in programming and troubleshooting of Biomek 2000, Spectramax 190, and Multimek. Perform PCR, process cDNA, DNA hybridization, and gel electrophoresis.

Performed data analysis for genotyping

CRI Inc. Laboratory Technician 1998 - 98

Instrumental, physical and analytical testing on catalysts, CBD, pore volume, particle length, carbons and sulfur

Performed testing to determine types of metals contained in catalysts

Responsible for training and monitoring Laboratory Technicians on CBD, metals, carbons and sulfurs

Prudential Healthcare Insurance Medical Claims Examiner 1997 - 98

Interacting with policyholders, claimants and attorneys to evaluate medical claim settlements

Received and evaluated medical reports to determine medical necessity, referral requirements, and CPT 4, ICD 9 codes validation

Maintained the day-to-day, weekly and monthly statistics of 30 claim examiners

Performed claim adjustments

Reported claim error by daily audit report or paper tracking

Macgregor Medical Medical Assistant/Administrative Assistant 1995 - 97

Assisted physicians by triaging patients before examinations as well as performed other patient care duties during examinations

Responsible for the development and implementation of safety programs used during patient care

Created a staff training program

Responsible for checking risk management proposals and quality assurance

Tested content built by IT for the HIM department and documented results

Responsible for scheduling, payroll, planning and supervision of 30 employees

VOLUNTEER EXPERIENCE

Jordan Memorial Church Financial Secretary 2010 - Present

Responsible for developing monthly financial reports showing analysis of financial accounts

Identifying and recommending modifications to existing procedures to improve efficiency

Weekly input of donations and receipts into the finance system

Identifying and implementing cost-reducing measures

Filing and archiving all receipts, statements and correspondence

Genometrix Inc. OSHA Committee Member 1999 - 01

Assisted in the implementation, execution, and oversight of Genometrix safety and health programs

Performed audit functions to assure compliance with regulatory requirements and company policies & procedures

Assist operation teams with planning, preparation, and presentation of safety training sessions

EDUCATION

University of Phoenix, Houston, TX

Master of Business Administration

Graduation Date: July 2012

Prairie View A&M University, Prairie View, TX

Bachelors of Science in Biology

Graduation Date: May 1995

CERTIFICATIONS

First Aid/Adult CPR/AED

Certified: September 2012 to current

Hazardous Materials & Waste Transportation

Certified: November 2012 to current

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