Clinical Research Associate I-FSP

Key Accountabilities:

•  Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.

•  Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.

•  Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.

•  Provides regular site status information to team members, trial management, and updates trial management tools.

•  Completes monitoring activity documents as required by SOPs or other contractual obligations.

•  Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.

•  Escalates site and trial related issues per SOPs until identified issues are resolved or closed.

•  Performs essential document site file reconciliation. •  Performs source document verification and query resolution.

•  Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.

•  Verifies SAE reporting according to trial specifications and ICH GCP guidelines.

•  Communicates with investigative sites.

•  Updates applicable tracking systems.

•  Ensures all required training is completed and documented.

•  Serves as main observer/assessor of site activities.

•  Facilitates audits and audit resolution.

•  To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g., protocol amendment submissions, Investigator site budget negotiation.

Skills:

•  Proven organizational and presentation skills.

•  Ability to manage multiple tasks and meticulous attention to detail.

•  Agile & quick learner, good team player

•  Willingness and ability to train others on study administration procedures.

•  Excellent written and verbal communication skills.

•  Good written and spoken English.

•  Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint, and Outlook, etc.

Knowledge and Experience:

•  1 - 2 years clinical monitoring experience required. CRAs with less experience may be considered based on level of mentoring available.

•  Read, write, and speak fluent English; fluent in host country language required.

•  Oncology experience preferred.

•  a licensed healthcare professional (i.e., registered nurse); or equivalent work experience required.

Education:

Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution.