1 Yr Contract Clinical Trial Assistant (Up to $5500/ West) #HGNJ

We are hiring 1 Yr Contract Clinical Trial Assistant to be outsourced to our clients from reputable healthcare organizations.

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Job Responsibilities

• Support Clinical Project Managers (CPMs) and study team with administrative, documentation, TMF, budget management and logistic activities related to Clinical studies during the operational phase of clinical trials to ensure the timely delivery of quality data while complying with internal Standard Operating Procedures, applicable laws and ICH Good Clinical Practice

• Supports high-quality electronic Trial Master Files (eTMFs). Performs set-up, maintenance (filing and approving documents) and archiving of eTMFs.

• Provides CRO oversight by developing eTMF guidelines and establishing review processes.

• Manages documentation of clinical studies in compliance with Good Clinical Practices (GCP) and relevant Standard Operating Procedures (SOPs) and perform filing QC

• Supports CPMs with budget and invoice management: vendor creation, checking of good receipt and payments, uploading invoice information in Finance budget tool, assist on planning of commitments monthly and keeping track of actual spending for each study.

• Supports maintenance of clinical studies management tracking tools and trackers. Support study team to register study on ct.gov.

• Assists study team with trial management logistical support (sample or ancillary shipments, procurement of study supplies, organizing trainings).

• Assists study team in the quality check of protocols, informed consent forms and advertisement materials to ensure compliance with SOPs and regulatory requirements.

• "Supports organization of clinical meetings (internal meetings, meetings with CROs, Investigators meetings, etc.) including agenda, minutes, logistics.

• Assists in managing global communications (e.g., Newsletters, emails, website posting).

• Assists with the preparation, review and maintenance of SOPs, work instructions, training materials, and templates related to project activities.

• Contributes to continuous improvement of working processes (for example supporting data entry into CTMS, SOP/SWI revision)

- Degree: A bachelor's degree in life sciences, nursing, or a related pharmaceutical field.

- Experience: 1 to 3 years of clinical research experience or strong administrative experience.

- Regulatory Knowledge: Basic understanding of ICH-GCP (International Council for Harmonisation - Good Clinical Practice) and local ethics rules

• Able to commit for minimum 1 year

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Please include your full working experience, education background, notice period, expected salary.

Quek Jing Qian

Outsourcing Team

Ref Code: #HGNJ

Recruit Express Pte Ltd

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We regret to inform that only suitable candidates will be shortlisted for an interview.