Clinical Research Associate

CLINICAL RESEARCH ASSOCIATE (INDONESIA)

PT Bio Medical Services is a local-leading healthcare intelligence and Clinical Research organization, which provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

PT Bio Medical Services are currently recruiting for a Junior CRA to work on a range of key therapy areas. The Clinical Research Associate (Permanent) will collaborate closely with investigative study sites to complete required site visits (SQV, SIV, IMV, COV) and perform site management activities to ensure project timelines and deliverables are met.

The CRA must build and maintain strong collaborative relationships with investigative sites, as well as leverage strong knowledge of protocol and regulatory guidelines to ensure protection of subject safety, protocol compliance, adequacy of study staff, and validity of study data. The CRA must be well organized, have high attention to detail skills, be able to adapt quickly to changing priorities, and propose well throughout solutions.

Responsibilities include but are not limited to:
 

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plan
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Monitor data for missing or implausible data
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines
• Ensure audit readiness at the site level
• Prepare accurate and timely trip reports
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Participate in and follow up on Quality Control Visits (QC) when requested
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
• Might be requested to work in a client facing environment
• Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE

Independently perform CRF review; query generation and resolution against established data review guidelines on Bio Medical Services or client data management systems as assigned by management.

Qualifications:
 

• University degree in scientific discipline or health care (University Students are also acceptable)
• Experience in Pharma Industry, and/or Clinical Trials environment is an advantage
• Very good computer skills including MS Office
• Excellent command of Indonesian and English language, Indonesia based
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Flexibility to travel
• Driver’s license 

What you can expect: 
 

• Company Training
• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Excellent working environment in a stabile, international, reputable company

If you are interested in the position, please contact:

Ms Sahmi Fitriyati

[email protected]

+62 85180891117