Regional CRA
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICHGCP 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 closed8. Performs essential document site file reconciliation
Performs source document verification and query resolution10. Assesses IP accountability, dispensation, and compliance at the investigative sites
Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICHGCP guidelines
Communicates with investigative sites
Updates applicable tracking systems
Ensures all required training is completed and documented
Serves as observation visit leader
Facilitates audit s 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
Desired Skills and Experience
Undergraduate degree or its international equivalent in clinical, science, or health?related field from an accredited institution; a licensed healthcare professional (i.e., registered nurse); or equivalent work experience required
4
years of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (PREFERRED)
Must be within 1 hour of a Major airport and have monitoring experience in 2 or more of the following Therapeutic Areas (Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS or Infectious Disease)
About Beacon Hill Pharma:
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.Estimated Salary: $20 to $28 per hour based on qualifications.
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