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 institut