Clinical Research Assistant

DEWI SARASTI PAMIKATSIH

Sewickley, PA 151**-***-*** 5755 **********@*******.***

INTERPRETER - Part Time, 01/2020 - Current

Steel City Interpreter – Pittsburgh, USA

• Interpreting Bahasa Indonesia - English Language from 2020 - present. Convert spoken words from Bahasa Indonesia (Indonesian Language) into English Language vice versa, in realtime, during meetings, in court, zoom meetings, conferences, hospitals (doctor - patient communicators), or other events.

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To listen carefully, understand the contents, memorize the key points to accurately reproduce statements, questions and speeches.

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• Bridging between individuals or groups who doesn't share a common language.

• Ensuring effective and clear communication.

Culturally sensitive, understanding nuances in language and communication styles across different cultures.

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• Remain neutral and avoid injecting personal opinions or biases into interpretations.

• Work in different settings: including legal, medical, educational and business contexts.

• Taking notes and conduct research to prepare for specific assignments or topics. Maintaining high level of professionalism and adhere to ethical standards including confidentiality and impartiality.

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Senior Clinical Research Coordinator, 11/2010 - 07/2015 MERLIN MD – Singapore

• Company Overview: Medical Device Manufacturing Company Create Clinical Investigation protocol and report, feasibility and budget evaluation for Medical Device of Neuro-Endovascular Treatment.

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Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and MEDDEV guidelines.

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Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure

'Good Clinical Practice' (GCP), and conduct close-out visits.

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• Identify site issues and initiates correction plans based on monitoring reports.

• Perform investigative site file reconciliation: requests any new and updated site-related essential and EXPERIENCE

non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, MEDDEV guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.

Verify data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner.

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• Ensure subject safety and adverse event reporting to sponsor and IRB/EC.

• Verify drug accountability logs and storage requirements.

• Responds to requests from investigative sites in a timely fashion. Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.

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• Human-use registry Coordination with local hospitals and physicians (INRs)

• Managing device stock-inventory for local and/or non-local human cases

• Coordinating with R&D for performing the device, handling complaint and correction action

• Coordinating human-cases in Malaysia with the local and non-local physicians in South East Asia

• Conducting Workshop in Malaysia attended by INRs from Europe and South East Asia.

• Building up the Clinical Investigation and Clinical Evaluation Report based on MedDev 2.7.1 Rev3.

• Initiating Gap Analysis of European Committee Regulation between revisions.

• Handling Clinical and Product Registration in South East Asia countries.

• Handling annual audit by the Notified Body and taking care of the non-conformities.

• Medical Device Manufacturing Company

Developed 2-day Workshop Plan and launched it involving Europe and South East Asia Interventional Neuroradiologist (INRs) with a limited budget and sources.

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• Built a sales network in Malaysia with physicians, distributors, importers and competitors.

• Accomplished 2-3 years Clinical Trial in Germany, Spain and Mexico.

• Submitted a Clinical Trial Report and obtained a CE-Mark.

• Audit handling annually in Clinical and Regulatory sectors.

• Planned and built Clinical Reports.

General Medical Check-Up Consultant, 02/2003 - 05/2007 PRODIA – Indonesia

• Company Overview: Laboratory and Clinic

Handling all the medical-checkup results and giving consultation to patients and/or organizations as required.

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• Laboratory and Clinic

Occupational Health Care implementation on the Multi-National Companies (MNCs) and Government sectors.

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Passenger Ship Doctor, 01/2002 - 01/2003

FARINA NUSANTARA – Borneo, Indonesia

• Company Overview: Passengers (n=2000) Ship

• Provide onboard medical care and treatment for the crews and passengers. Provide patient care both in the ships medical center and on-site emergencies as the situation dictates onboard.

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• Oversee the functioning of entire shipboard medical facilities on the passenger-ship.

• Passengers (n=2000) Ship

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