Clinical research specialist Jobs in Phoenix, AZ

Job Description

Job Description

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary :

The Senior Clinical Research Associate (Sr. CRA) independently manages clinical trial research sites to ensure research trials are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives. Sr. CRA will perform monitoring and site management work for a variety of protocols and sites.

Essential Functions :

• Perform onsite or remote site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with TD2 policies and contract scope of work and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Perform 80% source data verification (SDV) (or per CMP requirements) unless a risk-based monitoring approach (per Sponsor) is deemed appropriate for the trial, to ensure source documentation and case report forms (CRFs) are consistent with protocol requirements, ICH / GCP, and ALCOA principles.
• Work with sites to adapt, drive, and track subject recruitment plan in line with the project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Interface with principal investigators and site staff routinely to ensure timely resolution of issues, trial oversight, and subject safety concerns with the PI and site staff .
• Create and maintain appropriate documentation regarding site management, monitoring visit findings, protocol deviations, and action plans by submitting regulator visit reports, generating follow up letters and other required study documentation.
• In collaboration with the Clinical Trial Assistants (CTA), manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• May provide support during start-up phase.
• Ensure copies / originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements to ensure audit ready TMF.
• Provide the Clinical Trial Management (CTM) team with input for the trial Clinical Monitoring Plan (CMP).
• Immediately report any suspected fraud, misconduct, or serious breaches in the trial to the PM team and Associate Director of Clinical Monitoring.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate with cross functional teams to ensure study timelines and deliverables are met.
• Maintain appropriate CRA and study training requirements as per the TD2 Training Matrix.
• Performs other related duties as assigned.

Job Requirements :

Required Specialized / Technical Skills :

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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