Clinical Research Associate

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
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This role will be based in Mexico City, Mexico.

Key responsibilities include: 

• Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out.

• Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.

• Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.

• Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues.

• Ensuring the integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines

Requirements:

• Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.

• Working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.

• Must have excellent English verbal and written,

Working Conditions:

Previous experience in a Clinical Research Organization is required. The job requires disposition to work flexible schedules and travel regularly. Standard office work conditions apply and communication resources (cell phones, internet access, laptop, etc.) will be provided. Capacity to deal with stressful situations and deadlines is required. Regular work schedules (working days Monday through Friday).

Apply here: https://www.linkedin.com/jobs/view/2250074430/

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