Clinical Research Medical Assistant

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Melissa K. Nkematu, NRCMA-CRC

Cell 214-***-****

Email:adznm1@r.postjobfree.com

OBJECTIVE

A formally trained hands-on clinical research and medical device professional with 12 years of combined industry experience seeking a challenging position SUMMARY OF QUALIFICATIONS

● Working knowledge of ICH/GCP guidelines and FDA regulations.

● Working knowledge of clinical trial methodology and medical terminology.

● Working knowledge of database management including SAS programming and 3+ years of experience with Medidata, Oracle EDC, ClinoForm, ePRO, OC-RDC and INFORM.

● Experience working with Clinical Trial Management System (CTMS)

● Insightful in review and disposition of serious adverse events and medically related reporting for clinical trials.

● Independent, self-motivated and 3+ years of experience working with cross-functional teams in a matrix environment.

● Working knowledge of project management and basic risk management principles according to PMI guidelines (initiation, execution, monitoring, controlling and closing)

● Understanding of contract development responsibilities including: intellectual property rights and clinical trial sponsor interactions and negotiations. EDUCATION & ACCREDITATION

Texas Woman’s University, Denton, TX 2018-Current

Westwood College, Dallas, TX 2005 Diploma: Registered Certified Medical Assistant WORK EXPERIENCE

Abbott formerly St. Jude Medical Inc, Neuromodulation Division, Plano, TX 08/2011-08/2019 Analyst II, Product Surveillance

● Perform complaint handling and associated activities pertaining to product complaint investigation for SJM-NMD

● Receive and investigate reports of worldwide complaints/events on a variety of products

● Investigate complaints/events in a timely manner

● Maintain accurate entry of complaints in database

● Independently assess the complaint to determine if an adverse event report needs to be filed with various global regulatory agencies (e.g. FDA, European Competent Authorities) and submits applicable reports within required deadlines according to regulations and department procedures

● Archive complaint records & retrieves information on previous investigations

● Supports complaint database upgrades and conversions by providing input and performing system testing, etc.

● Ensure accurate department procedures and work instructions are followed and maintained

● Support inspections by regulatory agencies (e.g. FDA, Notified Body) as requested Page 2

Baylor Endocrine Center, Dallas, TX 06/2010-08/ 2011 Clinical Research Recruiter (contractor)

● Responsible for patient enrollment in several Phase I-V Endocrinology Clinical Trial Studies

● Responsible for maintaining patient and study databases (IRIS/Study Mgr)

● Perform all phlebotomy and protocol test procedures (EKGs, Vitals)

● Process lab specimens (IATA Certified)

● Recruiter for new and current enrolling studies (clinic database, hotline, advertisement, chart review)

● Complete Safety Reports (electronic)

● Case Report Forms (electronic and paper-based)

Medical Edge/Leading Edge Research Group PA Dallas, TX 06/2006-08/2009 Clinical Research Coordinator

● Manage multiple research studies between two clinical trial sites

● Manage study start-up activities by developing CRFs, ICF, enrollment logs, and drug/device accountability logs.

● Establish and organize study file, regulatory binders, and create study specific source documentation.

● Assist PIs with managing day to day activities for the assigned studies

● Provide appropriate training and tools for study team members.

● Develop, implement and ensure adherence to the monitoring plan to oversee study monitoring activities.

● Review and track monitoring follow-up reports

● Responsible for ensuring patient safety is maintained and that all safety issues are reported according to the relevant regulatory requirements (SAE and AE’s)

● Responsible for accurate and timely electronic data entry per protocol

● Responsible for resolving data queries and completing data correction forms (DCFs).

● Maintain effective and ongoing communication with sponsor, research participants and PI during the course of the study.

● Collaborate with the PI to prepare IRB and any other regulatory submission as required

● Performed all protocol test procedures; informed consent, phlebotomy, vitals, drug accountability, injections and EKGs

● Primary Recruiter for all assigned studies

● Conducted research studies in compliance with all FDA; HIPAA guidelines and Good Clinical Practices

Southwest Rheumatology, Mesquite, TX 06/2004-06/2006 Medical Assistant/Clinical Research Assistant

● Clinical support to Rheumatologist, Gastroenterologist and Nurse Practitioners

● Perform IV Infusions

● Scheduler for GI lab procedures; conducted pre-op and post-op education

● Research Assistant to Lead Study Coordinators

● Assisted with processing of regulatory documents REFERENCE(S):

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● Available Upon Request

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