Clinical Research Associate II (FSP)

Key Accountabilities:

Study Team Supporting

• 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.
• 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 site.
• May 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

Compliance with Parexel standards

• Comply with required training curriculum.
• Complete timesheets accurately as required.
• Submit expense reports as required.
• Update CV as required.
• Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements.

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:

• 2 - 4 years of clinical monitoring experience required. A licensed healthcare professional (i.e., registered nurse); or equivalent work experience required.
• Read, write, and speak fluent English; fluent in host country language required.
•  Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
• An advanced degree (e.g., 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.

Education:

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