Clinical Research Associate I 2 Senior

**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.