Clinical Research Associate

Tigermed; Colombia; On-site; COP 24,000,000 - 38,000,000; Full time

Job summary

Tigermed Colombia is seeking a Clinical Research Associate (CRA) to manage site selection, initiation, monitoring, and close-out in line with ICH-GCP and sponsor SOPs.

You will ensure high-quality data, timely payments, and budget adherence while training site staff and maintaining essential documents. English proficiency and 1–2 years CRA experience required.

Qualifications

• Bachelor degree or above in Medical, Pharmacology or Biology related major.
• 1–2 years of CRA experience.
• Good command of written and verbal English.
• Proficiency with MS Word, Excel, PPT and Outlook.

Responsibilities

• Study site selection, initiation (SIV) and monitoring.
• Provide ongoing site staff training on ICH-GCP and study protocol.
• Conduct site initiation to ensure understanding of protocol.
• Ensure timely collection and archiving of essential documents.
• Prepare study records and trial master file maintenance.
• Disseminate safety information to sites per SOPs and regs.
• Ensure SAE reporting within required timelines.
• Manage Study Payment Schedule and contract sign-off before site initiation.
• Update and maintain Study tools/systems.

Skills

Communication skills

Information-gathering skills

Education

Bachelor degree in Medical/Pharmacology/Biology

Tools

MS Word

MS Excel

PowerPoint

Outlook

Job description

• This position is responsible for project management and study site management from site selection toinitiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermedor sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization GoodClinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicableregulations;
• The position is responsible for ensuring that all data generated by the assigned sites is of high quality,on time and within budget.

2. Responsibilities:

• Study site selection, initiation (SIV) and clinical monitoring;
• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements;
• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements;
• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files;
• Prepare/complete study records’ archiving according to protocol and sponsor requirements;
• Ensure safety information is disseminated to all sites according SOP and applicable regulations;
• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations;
• Finalize budget and obtain signed contract from site, prior to site initiation visit;
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts;
• Update and maintain Study tools/systems in a timely manner.

3. Qualifications:

• Bachelor degree or above in Medical, Pharmacology or Biology related major;
• Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
• At least 1-2 years of CRA experiences;
• Good command of written and verbal English;
• Good skills on Microsoft Word, Excel, PPT and Outlook, etc.;
• Other abilities such as Communication skills/Information-gathering skills. Knowledge and/or experience in medical practice is a plus.