CRA

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigational 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.

· Functions independently with minimal oversight required

· May serve as subject matter expert for CPM on monitoring related activities

· May be assigned to multiple studies and/or sites

· Provides leadership skills to assigned projects and within the Clinical department

· May serve as delegate to CPM per need

Qualifications

The candidate is expected to have:

· at least 2 years of clinical monitoring experience; preferred in CRO

· a university degree in Pharmacy, Life Sciences or other related field;

· advanced level of English language skills;

· good planning, organization and problem solving abilities;

· good communication and interpersonal skills;

· a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives

and follow up of SAEs;

· excellent and current knowledge of GCP, ICH and local regulatory authority regulations.

Skills

• Strong interpersonal, written and oral communications skills.

· Ability to function efficiently and independently in a fast-paced, changing environment

• · Excellent organizational abilities