Clinical Research Associate

Clinical Study Coordinator

Primary responsibilities of the position

Serves as a primary contact between the company and study sites. Coordinates all correspondence among internal and external study stakeholders (investigators / IRBs / CRO). Ensures timely transmission and verification of clinical files & data and effective communication on the site status and issues handling.

Where required, participate in the site selection process. Performs site qualification visits and evaluates the capability of the site to successfully manage and conduct the clinical study in terms of sufficient patients/samples/study staffs, technical qualifications, GCP competency of investigators.

Where applicable, works with the study group to coordinate activities with the site in preparation for the initiation of studies including IEC submission, regulatory submissions, contracting, and other necessary submissions (e.g. HGA) for site activation. Obtains regulatory approvals according to local IRB/health agency/relevant authority requirements.

Coordinate the company resources with sites for instrument setup and IQ/OQ, testing procedure training, and test proficiency verification where applicable.

Performs study initiation activities including visits to study sites, receipt, and storage of study supplies, collection of SIV documents/records. Trains and reviews with the site investigators on the protocol, regulatory requirements, study SOPs, data entry and transmission procedures, and integrity of site binders. Reports back to CSL for SIV status/follow-up actions enabling site readiness.

Conducts periodic IMVs according to monitoring plans adhering to GCP and company SOPs. Performs SDV and assures documents and data integrity. Assures investigator compliance by continuous training, improvement actions, and risk mitigations if deviations occur. Acts as primary contact with sites for all correspondences and coordination with study groups (CSL/CTA/DM) throughout the study phase. Reports back to CSL for IMVs status/follow-up actions in a timely manner using the company's SOPs.

Serves as the primary contact to local IRB or other compliance offices (e.g. GCP institutions and HGRA). Assures timely submission and update reports to the following requirements, maintains relevant documents at binders, and corresponds to CSL on progress or issues.

Responsible for forecasting a sufficient supply of study materials (reagents, consumables, and files) according to site consumptions. Maintain documents and inventory accountability following company SOPs for all materials in safe and good storage.

Ensures timely transmission of clinical data with sites by collecting CRFs or on-site data entry of EDC. Reviews the quality and integrity of the clinical data through on-site SDV and timely solving data queries. Works with DM on database verifications, database lock, and related reviewing processes.

Works with CTA on electronic online maintenance of study binders (eTMF) ensuring integrity by timely upload/update/review/approval of documents following SOPs.

Position Requirements

Essential skills & Experience:

• Bachelor's degree in, biology, life sciences, medical or related areas.
• Minimum 2 years working experience of clinical trials with IVD company; other devices or pharmaceutical clinical operation experience will be considered.
• Certification of GCP.
• Hands-on knowledge of Regulatory requirements of assigned working regions (e.g. FDA, CE, ICH GCP, ISO 14155/20916, NMPA, etc).
• Understanding of Electronic Data Capture (EDC) and electro-online file managements (e.g. eTMF).
• Proficient English oral and written communication; local language proficiency required if assigned to specific regions.
• Proficient with Microsoft Office Word and Excel, etc.

Desirable Education and experience background:

• Advanced Degree in life science, medical, or clinical laboratory-related areas.
• Experience of being site monitor with diagnostic clinical studies or clinical laboratory management.
• The experience involved in IRB submission and review.
• Knowledge in IVD products especially molecular diagnostics preferred, capable of understanding IVD product design control process, CLSI guidelines, ISO 13485, etc.
• Authoring or facilitating clinical study documents e.g. Protocols, Investigator Brochure, Informed Consent Documents, CRFs, etc.
• Training or certified course in clinical study management including good clinical practice.
• Good understanding of project management; Hands-on experience with project management tools (e.g. MS Project, Omniplan, etc).
• Skills in reading, analyzing, and interpreting scientific, medical, and technical information relating to therapeutic areas or clinical diagnostics.