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.
- 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.