Clinical Research Associate

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

Essential Functions:

• Responsible for performing onsite and/or remote visits, including selection, initiation, monitoring and close out visits, in accordance with TD2 controlled documents and policies, contract scope of work, Clinical Monitoring Plan (CMP), and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Perform source data verification (SDV) and source data review (SDR) per CMP requirements, including using a risk-based monitoring approach if deemed appropriate for the trial, to ensure source documentation and case report forms (CRFs) are consistent with protocol requirements, ICH/GCP, and ALCOA principles.
• Coordinate with ethics and safety committees, the trial team, to safeguard the rights, safety, and wellbeing of trial participants throughout the trial. Ensure safety activities (e.g., AEs, SAEs, IND Safety Reports) are accurately performed, classified, and reported.
• Accountable for obtaining, reviewing, and verifying that the current version of the Informed Consent Form (ICF) has been appropriately obtained and signed for each participant participating in the trial. Verify that ICF updates are IRB approved and used for each patient enrolled.
• Ensure proper site activation and continued participation in the trial by reviewing the Investigative Site File (ISF) and collecting trial Essential Documents. Review the Investigator Site File (ISF) routinely and ensure that it is maintained in accordance with ICH GCP and local regulatory requirements.
• Ensure that only eligible patients are enrolled in the trial at each site.
• Work with sites to track and drive recruitment and adapt the recruitment plan in line with the trial needs to enhance enrollment predictability.
• Strong ability to build relationships with the Principal Investigator (PI) and trial personnel to establish regular lines of communication and effectively manage ongoing expectations.
• Administer protocol and trial-related training to assigned personnel and re-train as needed throughout the trial.
• Evaluate the quality and integrity of site practices (e.g., pharmacy, laboratory, training, documentation) for the proper conduct of the protocol and adherence to applicable regulations.
• Perform ongoing site management during and between site visits, including query resolution, follow-up on issues and protocol deviations.
• Escalate site quality issues and protocol deviations quickly and work with the TD2 trial team and Sponsor for resolution and site re-training as needed. Immediately report any suspected fraud, misconduct, or serious breaches in the trial to the PM team and Head of Clinical Monitoring.
• Create and maintain appropriate documentation within the Clinical Trial Management System (CTMS) regarding site telephone contacts, site management, monitoring visit findings, trial issues, protocol deviations, and action plans by generating regular contact reports, monitoring visit reports (MVR), visit confirmation letters (CL), follow up letters (FUL), and other required trial documentation.
• Manage the progress of assigned sites by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data query generation and resolution, sites issues, and protocol deviations.
• Ensure copies (or originals as required) of site documents are submitted for filing in the Trial Master File (TMF) to ensure an audit-ready TMF, including Essential Documents, training documents, laboratory documents, and Investigational Product (IP) records.
• Provide routine frequent updates on site activities such as enrollment, recruitment, essential document collection, data entry, issues/protocol deviation trends, concerns, and training needs to TD2 trial staff (e.g., PM, CTM, MM, CTA, DM).
• Collaborate with cross-functional teams to ensure trial timelines and deliverables are met.
• Maintain appropriate CRA and trial-level training requirements per the TD2 Training Matrix.
• Performs other related duties as assigned.

Job Requirements:

• Bachelor's degree (or international equivalent) in nursing, medical technology, or life science/health-related field. A bachelor's degree in another field with relevant experience may be substituted at TD2's discretion.
• Minimum of 2 years working in Phase I and II clinical trials in a Clinical setting.
• Minimum of 2 years in the therapeutic field of oncology.

Required Specialized/Technical Skills:

• Prior experience in working in clinical research, including knowledge of Good Clinical Practice (GCP) guidelines.
• Strong working knowledge of MS Office products including Word, Excel, and PowerPoint.
• Strong knowledge of regulatory (e.g., GCP, ICH, FDA, or country-specific regulations), technical, and clinical conduct of oncology clinical research trials.
• Understanding of the principles of clinical research with the ability to effectively guide clinical trial site staff.
• Highly efficient with the ability to use multiple trackers and systems to organize work across multiple research trials and sites.
• Capacity to identify and address issues that may arise during clinical trials
• Excellent written and verbal communication skills to interact effectively with study sites, sponsors, and regulatory bodies.
• Able to work under tight timelines.
• The ability to travel extensively (75%) within North America is a main part of this position

Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

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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