- 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.

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📌 Clinical Research Associate (Colombia)
🏢 Tigermed
📍 Colombia