Clinical Trial Assistant

1 month ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Roles & Responsibilities


Duration 1 year (Start Jan 2025)

Salary : up to 4500

Location: Boon Lay


Jobscope:


• 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, establishing review processes, and ensure the filing completeness.

• 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 vendor creation, budget and invoice management: 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.


Requirement:

• Min. Bachelor’s Degree in health care, life sciences or related field

• Has prior experience in in Food/Pharma/CRO industry or in an academic setting

• Records management experience in a GCP-regulated environment. Experience in clinical trials in Nutrition is an advantage

• Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the quality control process and compliance requirements in relation to TMF

• Solid experience of electronic document management system(s) and eTMF

• Proficient and agility in common office technology e.g. Microsoft tools, teleconferencing, etc.

• Strong general administrative skills and a minimum of 2 years of clinical studies administration experience


If interested, please email your resume to alexgoh@recruitexpress.com.sg or telegram me @alexgohhl


Alex Goh Hock Leong (Alvin)

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1763413



Tell employers what skills you have

Document Management
Quality Control
Archiving
TMF
CRO
Healthcare
Teleconferencing
Administration
Clinical Trials
Procurement
Nutrition
Regulatory Requirements
Life Sciences
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