Clinical Research Associate
7 months ago
**Job Description**:
**Position overview**:
The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites.
Participates in internal meetings and workstreams as SME for monitoring processes and systems.
**_ Responsibilities include, but are not limited to:_**
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased.
- Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
Could perform Quality control visits if delegated by other roles and trained appropriately.
**Education, Experience, Competencies**:
- CORE Competency Expectations:_
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands-on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including independent management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.
- Experience with conducting site motivational visit designed to boost site enrollment.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.
- Capable of mentoring junior CRAs on process/study requirements and is able to perform comonitoring visits where appropriate.
Behavioural Competency Expectations:
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Able to work highly independently across multiple protocols, sites and therapy areas.
-
Senior Clinical Research Associate
7 months ago
Ho Chi Minh City, Vietnam Parexel Full timeThe Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to...
-
Clinical Research Associate
6 months ago
Ho Chi Minh City, Vietnam IQVIA Full time**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...
-
Clinical Research Associate
2 weeks ago
Thành phố Hồ Chí Minh, Vietnam AstraZeneca Full time**Clinical Research Associate - Biopharm - Central** **About AstraZeneca and AstraZeneca Vietnam** **AstraZeneca** **AstraZeneca Vietnam** As a Foreign Invested Enterprise with over 600 members, AstraZeneca is investing into Vietnam 360 million USD from 2020 to 2030 with a focus on reducing the burdens of non-communicable diseases, developing local...
-
Clinical Research Associate Manager
6 months ago
Ho Chi Minh City, Vietnam MSD Full time**Position Overview**: This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line...
-
Travel & Event Administrator (6 Months)
4 months ago
Thành phố Hồ Chí Minh, Vietnam Oxford University Clinical Research Unit - Vietnam Full time**Mô tả công việc**: (Mức lương: 25 - 30 triệu VNĐ) JOB SUMMARY - Organize a variety of events for the unit. - Manage the process of submitting permissions and visas for foreign visitors and students to work at OUCRU and in different provinces. - Arrange team-building activities. - Coordinate the scheduling and utilization of the unit's vehicles...
-
Research Associate
6 months ago
Ho Chi Minh City, Vietnam CIMIGO Full timeResearch Associate Cimigo is one of the leading market research companies in Vietnam and Asia. We operate with the aspiration to serve as the voice of consumers. Understanding consumers and clients is the cornerstone of success for every business. Cimigo consistently listens to consumer needs and communicates them to manufacturers and service...
-
Associate Clinical Selling Manager
3 months ago
Thành phố Hồ Chí Minh, Vietnam Boston Scientific Corporation Full time**Job Description**: **Posted Date**: - Aug 13, 2024**Workmode**: - Hybrid**Job responsibilities**: Sales & Marketing - Work with channel partners to develop and deploy business plan for assigned territories - Visits existing and potential customers (e.g., physicians, physician office groups at hospitals) on a regular and planned basis to identify their...
-
Marketing Associate
8 months ago
Ho Chi Minh City, Vietnam TGM Research Full time**Location**: HCMC, Vietnam **About Us**: TGM Research is one of the fastest growing and most innovative market research companies, offering valuable insights to businesses across various industries. We are committed to delivering high-quality market research solutions to our clients by connecting them with the right participants through our online...
-
Pharma Associate
7 months ago
Ho Chi Minh City, Vietnam TẬP ĐOÀN Y KHOA HOÀN MỸ Full timeQuay Lại Trang Tìm Kiếm 30 giây trước **PHARMA ASSOCIATE**: Ứng tuyển ngay Vị trí TP. HCM Lương Thỏa thuận Công ty Tập đoàn Y khoa Hoàn Mỹ Phòng ban Performance Management Loại hình Full time **JOB SUMMARY**: - Support the operation and management of pharmaceuticals throughout Hoan My system to meet quality standards. -...
-
Research Associate
6 months ago
Ho Chi Minh City, Vietnam PERSOLKELLY Vietnam Full timeAttractive salary, benefit - Fluent English + Japanese listening, speaking, reading and writing skills - Gaining expert insights into market trends **Requirements**: - Advanced Japanese (N2 or higher). - Advanced English (minimum: IELTS 6.5 / TOEIC 945 / TOEFL iBT 90, or equivalent). - Highly organized, diligent, and personable. Excellent communication...
-
Senior Clinical Operations Manager
6 months ago
Ho Chi Minh City, Vietnam MSD Full time**Position Overview**: This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on local regulatory and financial compliance and...
-
Clinical Systems Administrator
8 months ago
Ho Chi Minh City, Vietnam Novotech Asia Full time**Brief Position Description**: **Minimum Qualifications & Experience: - Degree in a related field; computer science, information technology and/or information systems. - Experience in clinical trial systems supporting the CRO and/or pharmaceutical industry is required **Responsibilities: - Primary liaison with vendors and Novotech IT for maintenance...
-
Clinical Lead
8 months ago
Ho Chi Minh City, Vietnam Novotech Asia Full timeThis position is open to all APAC countries including AU and NZ. **Brief Position Description**: The Clinical Lead (CL) and Senior Clinical Lead provides direction and guidance to multi-country clinical teams in assigned project(s), coordinates site management and monitoring activities, and provides operational leadership for clinical teams to achieve...
-
Senior Clinical Project Manager
6 months ago
Ho Chi Minh City, Vietnam 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...
-
Associate Research Director
6 months ago
Ho Chi Minh City, Vietnam 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 Kantar is the world’s leading data, insights and consulting company. We understand more about how people think, feel, shop, share, vote and view than...
-
Clinical Trial Coordinator
6 months ago
Ho Chi Minh City, Vietnam MSD Full time**POSITION OVERVIEW**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...
-
Clinical Operations Manager
1 month ago
Thành phố Hồ Chí Minh, Vietnam MSD Full time**POSITION OVERVIEW**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...
-
Research Associate
6 months ago
Ho Chi Minh City, Vietnam 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
6 months ago
Ho Chi Minh City, Vietnam Công ty TNHH MTV CIMIGO Full time**Mô tả công việc**: (Mức lương: Từ 7 triệu VNĐ) **About us**: **Cimigo** is one of the leading market research companies in Vietnam and Asia. We operate with the aspiration to serve as the voice of consumers. Understanding consumers and clients is the cornerstone of success for every business. Cimigo consistently listens to consumer needs and...
-
Research Associate
6 months ago
Ho Chi Minh City, Vietnam Công ty TNHH MTV CIMIGO Full time**Mô tả công việc**: (Mức lương: 7 - 9 triệu VNĐ) - The main responsibility of this position is to support in designing, managing, and delivering projects for Cimigo's clients. - Additionally, this position will encompass a wide range of tasks. - Ensure research data is accurate and meets standards. - Project management and supervision: -...