Clinical Research Associate II
1 week ago
Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and liaising with vendors.
Key Responsibilities- Monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
- Ensure the integrity of 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 Company 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.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- 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.
- 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 Company or client data management systems as assigned by management.
- Assist with training of new employees, e.g., co-monitoring.
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
- Perform other duties as assigned by management.
- At minimum of 1(One) year of clinical monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow up of SAEs.
- Good planning, organization, and problem-solving skills.
- Ability to work with minimal supervision.
- Good communication and interpersonal skills.
- Good analytical and negotiation skills.
- Computer competency.
- Fluent in local office language and in English, both written and verbal.
- Works efficiently and effectively in a matrix environment.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Valid Driver's License.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
-
Clinical Research Associate II
7 days ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for conducting site monitoring visits, ensuring compliance with regulatory requirements, and maintaining...
-
Clinical Research Associate II
1 week ago
Shanghai, Shanghai, China PSI Full timeJob Title: Clinical Research Associate IIJob Summary:We are seeking a highly motivated and experienced Clinical Research Associate II to join our team at PSI. As a Clinical Research Associate II, you will be responsible for conducting and reporting onsite monitoring visits, performing CRF review, source document verification, and query resolution. You will...
-
Clinical Research Associate II
1 week ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and...
-
Clinical Research Associate II
3 weeks ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and...
-
Clinical Research Associate II
4 weeks ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a key member of our clinical operations team, you will be responsible for ensuring the integrity and quality of our clinical trials.Key ResponsibilitiesConduct routine...
-
Clinical Research Associate
1 week ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob Title: Clinical Research AssociateFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team.Job Summary:The Clinical Research Associate will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and...
-
Clinical Research Associate
3 days ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob Title: Clinical Research AssociateFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team.Job Summary:The Clinical Research Associate will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and...
-
Clinical Research Associate
2 weeks ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeJob SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring clinical sites, maintaining study files, and conducting pre-study and initiation visits. You will...
-
Clinical Research Associate
2 weeks ago
Shanghai, Shanghai, China PSI CRO Full timeJob Title: Clinical Research AssociateWe are seeking a highly skilled Clinical Research Associate to join our team at PSI CRO. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials.Key Responsibilities:Conduct site initiation, routine monitoring, and closeout visits to ensure compliance with regulatory...
-
Clinical Research Associate
1 week ago
Shanghai, Shanghai, China Novo Nordisk AS Full timeAre you passionate about driving innovation in the pharmaceutical industry? Do you want to make a meaningful impact on the lives of patients? We're seeking a skilled Clinical Research Associate to join our team at Novo Nordisk A/S.The RoleAs a Clinical Research Associate, you will be the primary point of contact between site staff and our company, acting as...
-
Clinical Research Associate
11 hours ago
Shanghai, Shanghai, China Fortrea Full timeJob SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Fortrea. As a Clinical Research Associate, you will be responsible for monitoring study sites, ensuring compliance with regulatory requirements, and maintaining accurate records.Key ResponsibilitiesMonitor study sites to ensure compliance with protocol and regulatory...
-
Clinical Research Associate
1 month ago
Shanghai, Shanghai, China PSI CRO Full timeJob DescriptionWe are seeking a highly skilled Clinical Research Associate to join our team at PSI CRO. As a key member of our team, you will have the opportunity to develop your expertise in clinical research and contribute to the success of our projects.Key Responsibilities:Conduct site initiation, routine monitoring, and closeout visits to ensure...
-
Clinical Research Associate
4 weeks ago
Shanghai, Shanghai, China PSI CRO Full timeJob Title: Clinical Research AssociateWe are seeking a highly skilled Clinical Research Associate to join our team in Shanghai. As a key member of our team, you will be responsible for conducting clinical trials, delivering training to investigators and site staff, and working with complex studies.Key Responsibilities:Conduct selection, initiation, routine,...
-
Clinical Research Associate
2 weeks ago
Shanghai, Shanghai, China MakroTech Full timeJob Title: Clinical Research AssociateJob Summary:MakroTech is seeking a highly skilled Clinical Research Associate to join our team in Shanghai, China. The successful candidate will be responsible for managing day-to-day clinical trial activities, ensuring compliance with protocols and regulatory requirements.Key Responsibilities:Manage daily clinical trial...
-
Clinical Research Associate
4 weeks ago
Shanghai, Shanghai, China MakroTech Full timeRole OverviewMakroTech is seeking a highly skilled Clinical Research Associate to manage day-to-day clinical trial activities in Shanghai, China. The ideal candidate will ensure compliance with protocols and regulatory requirements, reviewing clinical trial protocols, and participating in the design and execution of clinical studies.Key...
-
Clinical Research Associate
1 week ago
Shanghai, Shanghai, China MakroTech Full timeJob DescriptionRole OverviewMakroTech is seeking a highly skilled Clinical Research Associate (CRA) to manage day-to-day clinical trial activities in Shanghai, China. The CRA will ensure compliance with protocols and regulatory requirements, reviewing clinical trial protocols, participating in trial design and execution, collaborating with clinical...
-
Clinical Research Associate
3 weeks ago
Shanghai, Shanghai, China MakroTech Full timeRole OverviewMakroTech is seeking a highly skilled Clinical Research Associate to join our team in Shanghai, China. The successful candidate will be responsible for managing day-to-day clinical trial activities, ensuring compliance with protocols and regulatory requirements.Key ResponsibilitiesManage daily clinical trial operations and ensure compliance with...
-
Clinical Research Associate
1 month ago
Shanghai, Shanghai, China MakroTech Full timeJob SummaryMakroTech is seeking a highly skilled Clinical Research Associate to join our team in Shanghai, China. The successful candidate will be responsible for managing day-to-day clinical trial activities, ensuring compliance with protocols and regulatory requirements.Key ResponsibilitiesManage daily clinical trial operations and ensure compliance with...
-
Clinical Research Associate
1 month ago
Shanghai, Shanghai, China MakroTech Full timeJob SummaryMakroTech is seeking a highly skilled Clinical Research Associate to manage day-to-day clinical trial activities in Shanghai, China. The ideal candidate will ensure compliance with protocols and regulatory requirements, and have experience in clinical trials and monitoring.Key ResponsibilitiesManage daily clinical trial operations and ensure...
-
Clinical Research Associate
2 weeks ago
Shanghai, Shanghai, China IQVIA Full timeJob SummaryWe are seeking a highly skilled Clinical Trial Coordinator to join our team at IQVIA. As a Clinical Trial Coordinator, you will play a critical role in the successful execution of clinical trials, ensuring that all aspects of the trial are conducted in accordance with regulatory requirements and company policies.Key ResponsibilitiesManage trial...