Senior Clinical Research Associate
7 months ago
**Job Overview**
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
**Essential Functions**
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
**Qualifications**
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 4 years of on-site monitoring experience.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
-
Clinical Research Associate
7 months ago
Jakarta, Indonesia MSD Full time**JOB DESCRIPTION** Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company, one that is ready to help create a healthier future for all of us. Clinical Research Associate is accountable for performance and compliance for...
-
Clinical Research Associate
2 days ago
Jakarta, Indonesia Dexa Group Full timePrepare clinical study documents (protocol, CRF, Informed Consent Form, etc.) - Assist Principal Investigator for Ethics Committee submission - Responsible for Regulatory Affairs submission - Perform site feasibility, investigator selection, and site set up - Perform clinical trial monitoring, follow up and discussion with study site team - Responsible for...
-
Senior Clinical Project Manager
7 months ago
Jakarta, Indonesia ELITE ASIA (SG) PTE. LTD. Full timeOverall management and quality of a group of projects for a particular client, therapeutic area or other specialty area - role may be local, regional or globally focused depending on the group of projects under responsibility - Supervising all aspects of project delivery, quality and financial accountability managing the sponsors’ expectations in all...
-
Senior Clinical Project Manager
7 months ago
Jakarta, Indonesia ELITE ASIA (SG) PTE. LTD. Full timeOverall management and quality of a group of projects for a particular client, therapeutic area or other specialty area - role may be local, regional or globally focused depending on the group of projects under responsibility - Supervising all aspects of project delivery, quality and financial accountability managing the sponsors’ expectations in all...
-
Clinical Research Manager
2 months ago
Jakarta, Indonesia MSD Full timeThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several...
-
Sr Cra I
7 months ago
Jakarta, Indonesia Syneos - Clinical and Corporate - Prod Full time**Description** **Senior Clinical Research Associate I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and...
-
Clinical Education
1 month ago
Jakarta, Indonesia GE HEALTHCARE Full time**Job Description Summary**: Reporting to the Indonesia Country Manager, in this role, the incumbent will lead Clinical Education collaborations across the GE HealthCare (GEHC) portfolio for the Indonesia Zone in collaboration with AKA (ASEAN, South Korea, ANZ) Education Program Director with the following responsibilities - 1) Deliver Clinical Education...
-
Cra Ii
7 months ago
Jakarta, Indonesia Syneos - Clinical and Corporate - Prod Full time**Description** **Clinical Research Associate II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...
-
Senior Associate, Forensic Investigations and
3 months ago
Jakarta, Indonesia Kroll Full timeKroll’s Forensic Investigations and Intelligence practice assists clients in Forensic Investigations and delivering actionable data and insight business intelligence that help clients worldwide make critical decisions and mitigate risk. The Senior Associate is expected to be able to perform all methods of research, including desktop research, interviews,...
-
Junior Associates
1 week ago
Jakarta, Indonesia PT Steven Kho Indonesia Full timePersyaratan **Junior Associate Responsibilities**: - Conducting research on various topics to support more senior lawyers and consultants in advising the clients; - Preparing legal memorandum and presentations on various topics to support more senior lawyers and consultants in advising the clients; - Collaborating with other lawyers and consultants in...
-
Marketing Associate
1 week ago
Jakarta, Indonesia PT Inspirasi Makmur Sejahtera Full timePersyaratan Usia 25 - 40 tahun Pendidikan minimum D3 Pengalaman Kerja min 3 tahun (atau 5 tahun untuk Senior Associate) di bidang apapun Bersedia bekerja Full Time Gaji sebelumnya min Rp 5Jt / bln (Marketing Associate) / min Rp. 9Jt/bln (Senior Associate) Tanggung Jawab Mengikuti program training dan pelatihan PruVenture secara fulltime Mengikuti...
-
Indonesia - Senior Mel and Research Analyst
9 months ago
Jakarta, Indonesia BRAC USA Full timeThe BRAC Ultra-Poor Graduation Initiative (UPGI) seeks to hire a Senior Monitoring, Evaluation, Learning and Research Analyst (Senior MEL and Research Analyst) for BRAC UPGI Indonesia. Reporting to the Country Lead, the Senior Analyst will work closely with the UPGI Indonesia team to inform and help strengthen efforts to support national and local government...
-
Research Associate
7 months ago
Jakarta, Indonesia Boston Consulting Group Full time**WHAT YOU''LL DO**: **YOU''RE GOOD AT**: Engaging with customers - You will thrive learning in a rich, fast paced, deadline driven yet thoughtful environment that is customer focused. Working closely with more senior team members, you will engage with our Consulting and Knowledge Teams daily with the aim to understand, scope and deliver accurate, timely and...
-
Research Associate
7 months ago
Jakarta, Indonesia KANTAR Full timeWe go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. To start a career that is out of the ordinary, please apply... Job Details Research Associate - Quantitative As a Research Associate, you are responsible for learning the brand offer and ways of working to deliver efficient and...
-
Licensed Clinical Social Worker
1 week ago
Jakarta, Indonesia JVM Solutions Full time**JOB PURPOSE**: JVM is hiring a Licensed Clinical Social Worker to perform a full range of a Licensed Clinical Social Worker, using government furnished facilities, equipment and supplies to a variety of patients. **DUTIES AND RESPONSIBILITES**: - Conduct diagnostic biopsychosocial assessments utilizing clinical interview techniques, mental status...
-
Research Assistant
4 months ago
Jakarta, Indonesia Bunda Investama Indonesia Full timeResearch Assistant Requirement: - Having experience working in a clinical research organization (CRO) (at least 1 year) - Having experience in manuscript writing - Having at least 1 international publication - Able to work with a team member - Bachelor or master in major sciences - Experience with PCR, rt-PCR, and sequencing techniques Job description:
-
Research Associate
7 months ago
Jakarta, Indonesia KANTAR Full timeWe go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. To start a career that is out of the ordinary, please apply... Job Details RESEARCH ASSOCIATE - QUALITATIVE - As a Research Associate, you are responsible to provide day to day support to Directors, Managers and Executives across a...
-
Senior Research
2 days ago
Jakarta, Indonesia PT Info Cahaya Hero Full timeManaging the relationship with clients on a day to day basis and keeping them informed regarding the progress of projects - Lead projects - give direction to juniors with less supervision from seniors, make decision/suggestion to run the projects, create report and presentation - To ensure that industry and research knowledge is integrated from other...
-
Clinical Marketing Expert
7 months ago
Jakarta, Indonesia Greiner Full timeClinical Marketing Expert **Location**:Jakarta, ID, 13630**Travel activity**:75%**Employment Type**:Permanent**Your challenge** As a Clinical Marketing Expert, you’ll play a pivotal role in bridging clinical insights with effective marketing strategies for our consumable medical devices. Your focus will be on enhancing the clinical value proposition of...
-
Senior Associate, Forensic Investigations and
7 months ago
Jakarta, Indonesia Kroll, LLC Full timeIn a world of disruption and increasingly complex business challenges, our professionals bring truth into focus with the Kroll Lens. Our sharp analytical skills, paired with the latest technology, allow us to give our clients clarity—not just answers—in all areas of business. We embrace diverse backgrounds and global perspectives, and we cultivate...