Clinical Research Associate I

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.