(Senior) Clinical Research Associate
3 days ago
(Senior) Clinical Research Associate (CRA) Add expected salary to your profile for insights 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 regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. 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 supporting development of project subject recruitment plan on a per site basis. 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 1 year of on-site monitoring experience. Equivalent combination of education, training and experience may be accepted in lieu of degree. 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. #J-18808-Ljbffr
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Senior Clinical Research Associate
3 days ago
Kwai Tsing District, Hong Kong SAR China IQVIA Solutions Hong Kong Limited Full timeA global healthcare consultancy is seeking a (Senior) Clinical Research Associate in Hong Kong. The successful candidate will perform site monitoring and management to ensure compliance with study protocols and regulatory guidelines. Responsibilities include overseeing study progress, maintaining regulatory submissions, and collaborating with the study team....
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Senior CRA: Drive Clinical Site Excellence
1 week ago
Kwai Tsing District, Hong Kong SAR China IQVIA Full timeA leading global clinical research provider is seeking a Senior Clinical Research Associate in Hong Kong. You will be responsible for monitoring clinical sites, ensuring compliance with regulatory guidelines, and managing study progress. Ideal candidates should have at least 1 year of on-site monitoring experience and a Bachelor’s degree in a scientific...
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Clinical Trials Assistant
5 days ago
Kwai Tsing District, Hong Kong SAR China IQVIA Full timeClinical Trials Assistant (CTA) (Evergreen) Posted 6 days ago. Be among the first 25 applicants. Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start‑Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates...
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Clinical Trials Admin
5 days ago
Kwai Tsing District, Hong Kong SAR China IQVIA Full timeA leading global clinical research provider is seeking a Clinical Trials Assistant (CTA) to support the Clinical Research Associates and Regulatory teams in maintaining trial documentation and ensuring compliance. Responsibilities include managing clinical documents, assisting with study files, and preparing clinical trial supplies. Ideal candidates should...
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(Senior) Clinical Research Associate
2 weeks ago
Kwai Chung, Hong Kong SAR China HKG IQVIA RDS Hong Kong Limited Full timeJob 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...
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Senior Clinical Trials Site Monitor
2 weeks ago
Kwai Chung, Hong Kong SAR China HKG IQVIA RDS Hong Kong Limited Full timeA global clinical research organization is seeking a Clinical Research Associate in Hong Kong to perform monitoring and site management for clinical studies. You will ensure compliance with protocols and regulatory requirements. The ideal candidate has a Bachelor's Degree in a relevant field, at least 1 year of on-site monitoring experience, and strong...
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Clinical Trials Assistant
2 weeks ago
Kwai Chung, Hong Kong SAR China HKG IQVIA RDS Hong Kong Limited Full timeJob Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...
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Site Activation Specialist – Clinical Trials
1 week ago
Kwai Tsing District, Hong Kong SAR China IQVIA Full timeA leading global provider of clinical research services, this company is seeking a Site Activation Specialist to manage site activation and regulatory activities. The successful candidate will handle documentation and serve as a key contact for investigative sites, requiring a Bachelor's in Life Sciences and related experience. This full-time position offers...
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Clinical Trials Admin
2 weeks ago
Kwai Chung, Hong Kong SAR China HKG IQVIA RDS Hong Kong Limited Full timeA leading clinical research organization in Hong Kong seeks an Administrative Support professional to assist Clinical Research Associates and Regulatory teams in managing trial documentation and supplies. The ideal candidate has a High School Diploma and 3 years of administrative experience. Key skills include proficiency in Microsoft Office and a good...
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Tai Po District, Hong Kong SAR China Centre for Oncology and Immunology Full timePostdoctoral Fellow/Research Associate/Research Assistant (Immuno-Oncology Research) The long-term objective of the Centre for Oncology and Immunology is to employ novel functional screens, animal and cell models including organoids, immuno-oncology approach, as well as advanced genomic and proteomic techniques down to single cell resolution to identify...
