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Clinical Research Associate II (FSP)

Parexel International Corporation

Taiwan, Remote

Responsibilities may include
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 clinicalissues.

Escalates site and trial related issues per SOPs until identified issues are resolved or closed.Performs essential document site file reconciliation.

Assesses investigational product (IP) accountability, dispensation, and compliance at the investigativesites.

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

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.
Mentors junior-level CRAs and serves as a resource for new employees.
Serves as main observer of site activities, and may have some responsibilities for performance of siteMay be assigned additional clinical operations tasks:
May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
May be assigned clinical tasks where advanced negotiating skills are required.
Qualifications
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required.
Read, write, and speak fluent English; fluent in host country language required.
2 - 4 years of clinical monitoring experience required.
Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
An advanced degree (eg, MS, MBA, PharmD, etc) preferred.
Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV])preferred.
Experience in coaching/mentoring other CRAs preferred.

Job posted: 2023-08-22