This job is with Parexel, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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.
