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AI Summary
The Clinical Research Associate II implements and monitors clinical trials to ensure compliance with regulatory requirements and ICH GCP guidelines. They are responsible for site qualification, data verification, and facilitating the resolution of trial-related issues.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
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