Job Description

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:

• Bachelor’s degree in a life science health related field is preferred or international equivalent.
• Minimum of 5 years as a Sr. CRA monitoring Phase I and Phase II clinical trials in a CRO or pharmaceutical environment.
• Minimum of 4 years in the therapeutic field of oncology.

Required Specialized/Technical Skills:

• Strong knowledge in drug development process with experience monitoring complex adaptive design clinical trials.
• Strong working knowledge of MS Office products including Word, Excel, and PowerPoint.
• Strong knowledge of regulatory (e.g., GCP, ICH, FDA regulations), technical, and clinical conduct of oncology clinical research trials.
• Understanding of the principles of clinical monitoring with ability to effectively mentor/guide clinical trial site staff.
• Excellent problem-solving skills.
• Excellent verbal and written communications skills with an ability to distill regulatory concepts into compelling discussions.
• Able to work under tight timelines.
• Ability to travel extensively (75%) within North America as a main part of this position.

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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