Rekha Thomas, Bpharm, MS

Experience

• 

  Nakkara medicals

  Jun 2007 - Jun 2008

  Pharmacist

  *Thinks critically, changes and adapts quickly and sets appropriate priorities and interventionsin emergency situations.*Patient counseling, ensuring that the prescriptions are suitable for the patients and alsomaking sure safe supply of medicine within the law.* Understands basic pharmacy law and have the ability to embrace change positively.* Knowledge of drug names, standard dosages, dosage forms and delivery system andmedical terminology utilized in pharmacy.*Able to demonstrate excellent interpersonal and communication skills within a multi-disciplinary team.* Able to utilize computer application to enter data accurately and in line with productionstandards.*Performs the role of Team Leader and making appropriate staffing decisions. Show less

• 

  Walmart

  Mar 2012 - Oct 2012

  CPhT

  *Inputting customer and prescription data into computer, filling and labeling prescription bottleand compounding specialty medications.*Managed inventory, answering phone calls from customers or physician, and resolvingissues with insurance companies.

• 

  CVS Pharmacy

  Jun 2013 - Jan 2017

  CPhT

  Old order investigation- commitment to quality, communication with management and otherdepartments to solve prescription issues, focus on improvement of processes more efficientand effective. Identify customer’s expectation and meet them to customer’s satisfaction infast, safe and effective way.

• 

  AbbVie

  Jan 2017 - now

  • Manage accurate study start-up planning and execution of country and site level activities/tasks, demonstrating efficiencies to reduce start-up timelines.• Ensure continued progress and completion of study deliverables for the success of the study.• Keep customer centric approach in internal and external interactions.• Provides administrative and clinical management support to Site Management & Monitoring personnel and assist them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management & Monitoring personnel assigned to clinical studies conducted in US & PR.• Coordinate with sites to collect required documents during startup (Essential document preparation and collection form sites, FDA IND submission, Investigator Site File preparation and distribution, EC submissions, IP authorization, Greenlight letter), maintenance (PI changes, study updates), and closeout (TMF reconciliation, EC submission completion).• Preparing Country EC submission package.• Develop ICF Country template and site templates.• Manage site specific issue resolution related to EC submission.• Conduct EC submissions of clinical studies and related amendments. • Safety Letter EC submissions.• Collaborate with the Primary site monitor, clinical team, IRB, and sites for site activation. • Working on phase 1 through 4 studies • Therapeutic Areas- General Medicine, Immunology, Oncology, Neurology.• Work cross functionally to meet the study timelines.• Utilize system reports (TESLA, VISION dashboard, VAULT, ATRIUM, APPTUS) to ensure accuracy and completeness of the study.• Acts as in-house support for CRA’s with the handling and destruction arrangements of Investigational Product as, and if, required.• Active member of Inspection readiness task force team.• Assist in various initiatives (Phase 1/Non-Drug Studies, Let’s Talk Americas,Inspection readiness core team member, Women Leaders in Action) Show less Managed the study/site startup Phase 1 to 1V (SSL, GLL, IP, ED collection, CSA request, ED binders), maintenance (mass mailing, amendment distributions, PI change) and close out activities (archival process).Critically reviewed document content to ensure accuracy and completeness in order to Authorization to Release of investigational product (IP) to study sites.Prepared and submitted IP packets.Submission to IRB and ICF tasks .Keep track of site activation (TESLA-planned, selected, canceled, closed)Ensured required site documentation remains current during the conduct of a study, and providing safety and relevant study updates to the IRB.Managed the Trial Master File (TMF), ensuring documents maintained in the file are appropriate and the content of those documents is accurate, complete and consistent with Abbott SOPs and regulatory requirements.Ensured TMF health. (QC of Artifacts, ALCOA, Timeliness)Prepared sites for Site Initiation Visits (SIV) by ensuring initiation supplies are available.Tracking and reporting site/study status to the Clinical Team.Participated in the preparation activities required for regulatory and QA audits.Coordinating the distribution of communications to all sites (e.g. questionnaires, newsletters, mass mailings, etc.)Managed the translation and tracking of translations for appropriate study documents.Ensured all required documentation has been obtained by Abbott and is also available in the Investigators Site File.Ensured IP accountability documentation is complete, allowing for a successful reconciliation.Submitted required documentation for completion of a Clinical Study Report (CSR) or inclusion in a regulatory filing.Facilitate/Participation of study team meeting related to TMF management.Interaction with Abbott/Abbvie personals, external site & vendors. Show less

  • Sr clinical project assistant

    Dec 2019 - now

  • Clinical Project Assistant

    Jan 2017 - Dec 2019