Current jobs related to Clinical Research Associate Ii/iii/senior Cra - Singapore - NOVOTECH CLINICAL RESEARCH PTE. LTD.
-
Cra Ii
2 days ago
Singapore Syneos Health Clinical Full time**CRA II** **-** **(** **22005120** **)** **Description** **Clinical Research Associate II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career...
-
Fsp Cra Ii
3 days ago
Singapore Syneos Health Clinical Full time**FSP CRA II** **-** **(** **22007317** **)** **Description** **Clinical Research Associate II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career...
-
Cra Ii
2 weeks ago
Singapore ICON Full timeAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Senior / Clinical Research Associate
1 week ago
Singapore Consortium for Clinical Research and Innovation Singapore Full time**Job Title** Senior Clinical Research Associate (3 years Renewable contract) **About SCRI** The Singapore Clinical Research Institute (SCRI) is the national coordinating body (NCB) for clinical trials with a vision to establish Singapore as a regional thought leader in clinical research. This is accomplished through the deployment of innovative...
-
Clinical Research Associate
1 week ago
Singapore Precision Medicine Group Full timeClinical Research Associate / Senior Clinical Research Associate Clinical Research Associate / Senior Clinical Research Associate Get AI-powered advice on this job and more exclusive features. Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life...
-
Clinical Research Associate
1 week ago
Singapore Precision For Medicine Full timeClinical Research Associate / Senior Clinical Research Associate Clinical Research Associate / Senior Clinical Research Associate Get AI-powered advice on this job and more exclusive features. Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life...
-
Clinical Research Associate Ii
6 days ago
Singapore ICON CLINICAL RESEARCH (PTE) LIMITED Full timeIdentify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP - Depending upon experience, become involved, when required, in other areas of study...
-
Clinical Research Associate
2 weeks ago
Singapore Precision Medicine Group Full timeClinical Research Associate / Senior Clinical Research Associate Precision for Medicine is not your typical CRO. We combine new technologies, expertise, and operational scale to improve the speed, cost, and success rate of bringing therapies to patients. Our focus is on Oncology and Rare Diseases, integrating clinical trial execution with scientific...
-
Singapore beBee Careers Full timeAs a Clinical Research Associate or Senior Clinical Research Associate, you will play a pivotal role in the success of our clinical studies. Our team is dedicated to improving the speed, cost, and success rate of bringing life-changing therapies to patients.">About the Role:">You will be responsible for monitoring and managing clinical studies at...
-
Clinical Research Associate
1 week ago
Singapore Precision Medicine Group Full timeClinical Research Associate / Senior Clinical Research Associate Precision for Medicine is not your typical CRO. We combine new technologies, expertise, and operational scale to improve the speed, cost, and success rate of bringing therapies to patients. Our focus is on Oncology and Rare Diseases, integrating clinical trial execution with scientific...
Clinical Research Associate Ii/iii/senior Cra
2 weeks ago
**Brief Position Description**:
The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
**Minimum Qualifications & Experience**:
- Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
- At least 2-3 years of Clinical Research Associate experience in the industry
**Responsibilities**:
- The CRA's primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
- Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
- In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
- In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
- Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
- Monitoring of investigational sites as per ICH GCP -5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
- Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
- Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
- Ensure all investigational products are appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
- In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up-to-date, current and complete always throughout duration of the study.
- Support sites to be always audit and inspection ready.
- Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data.
- Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.
- Collaborate with IHCRA and Site Contract Associates, as applicable, on-site payments, taking ultimate responsibility on site payments to ensure payment execution as per term stated in Clinical Trial Agreement.
- Assist the PM with the development of study related project plans and templates as per study requirements and support tasks as needed for successful study execution.
- Be aware of and adhere to company processes in areas relevant to a CRA. Be quality focused on the performance of duties. Assist in the review and development of clinical SOPs and processes.
- Participate in activities of the Clinical Services Department, including presentations at clinical department meetings, and assisting with the development of clinical processes and SOPs.
- In collaboration with Business Development (BD), foster relationships with sites to provide feasibility information, as requested, and in accordance with documented feasibility processes. Highlight any BD opportunities to the group.
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company.
**CRA II**
- Responsible for learning the compa
