Research Coordinator Clinical

DEWI SARASTI PAMIKATSIH, MD, MM (SARAS POLCE)

**** *** ********* ***** **** Sewickley PA 15143 ● Phone: 724-***-**** ● **********@*******.*** Professional Experience

MERLIN MD, Singapore – Full, Medical Device Manufacturing Company Senior Clinical Research Coordinator, Full Time, 11/2010 to 07/2015 (4 Years, 8 Months).

● Create Clinical Investigation protocol and report, feasibility and budget evaluation for Medical Device of Neuro-Endovascular Treatment.

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

● Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice” (GCP), and conduct close-out visits.

● 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 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.

● 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.

● 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. Selected Accomplishments:

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

● 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.

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PRODIA, Indonesia – Full, Laboratory and Clinic

General Medical Check-Up Consultant, 2/2003 to 5/2007 (4 Years, 3 Months) Handling all the medical-checkup results and giving consultation to patients and/or organizations as required.

Selected Accomplishments:

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

FARINA NUSANTARA, Borneo, Indonesia – Full – Passengers (n=2000) Ship Passenger Ship Doctor, 1/2002 to 1/2003

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

DIPONEGORO UNIVERSITY, Semarang, INDONESIA

Medical Faculty, 8/2002

● Major: Medical Doctor

Economic Faculty, 05/2007

● Major: Master of Management

● Minor: Marketing

Skills

● Interpersonal Relationship

● Effective communication and negotiation skills

● Creative Team Leadership

● Hardworking

● Familiar with MS-OFFICE

● Development of Training Materials

● Self-driven and self-reliant

● Good strategic appreciation and vision

● Set aims and targets and leads by examples

● Language: English, Bahasa Indonesia, Malay

● Advanced user OSIRIX program software

Available Immediately

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