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PRAHS Clinical Research Associate 3 in United States

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

  • 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 onsite or remotely

  • Provides regular site status information to team members, trial management, and updates trial management tools

  • Completes monitoring activity documents as required by PRA 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 PRA SOPs, until identified issues are resolved or closed

  • Performs essential document site file reconciliation

  • Performs source document verification and query resolution

  • Assesses IP accountability, dispensation, and compliance at the investigative sites

  • Verifies Serious Adverse Event (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 observation visit leader

  • Facilitates audits and audit resolution

  • Mentors junior level CRAs and serves as a resource for new employees

  • Serves as observation and performance visit leader

  • 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

  • If responsible for supervising other CRAs: Schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with PRA’s policies, procedures, and

  • SOPs, and ensures HR processes are properly implemented

  • Serves as a Preceptor for new CRAs participating in the CRA Bridge Program

  • Functions independently with minimal oversight required

  • May serve as subject matter expert for CTM on monitoring related activities

  • May be assigned to complex studies and/or sites

  • Provides leadership skills to assigned projects and within the Clinical Operations department

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care 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

  • 5+ years of clinical monitoring experience required

  • Clinical research experience

  • Knowledge of ICH and local regulatory authority regulations regarding drug

  • An advanced degree (e.g., M.S., M.B.A., PharmD, etc)

  • Experience in monitoring complex trials

  • Participation in departmental initiatives

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

ID: 2019-54597

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL:

Post End Date: 8/16/2019