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:

This position is responsible for collaborating with the Clinical Monitoring and Project Management teams in management of clinical trial research sites to ensure research trials are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.

Essential Functions:

• Coordinate with Clinical Research Associates (CRAs) on the collection, naming, and upload of regulatory documents (e.g., Financial Disclosure Forms [FDFs], CVs/Medical Licenses, training documents) to the Trial Master File (TMF).
• Assists CRAs to maintain site specific correspondence list and ensure that the trial-level contact list is updated accordingly.
• Coordinate the preparation of Site Initiation Visit (SIV) presentations with the Clinical Monitoring and Project Management teams.
• Support assigned trial team members (e.g., Project Management, Site Engagement, Clinical Monitoring) with patient enrollment.
• Conduct and complete remote site management activities, with support as needed, according to applicable SOPs and the Clinical Monitoring Plan (CMP).
• May serve as contact for site for specific requests (e.g., enrollment updates, missing documentation, data entry timeliness, data query follow-up, action item resolution, CRA tasks).
• Serve as a contact for site clinical trial supplies and work with suppliers (vendors) as assigned.
• Assist Site Engagement and/or PM team with follow-up on feasibility assessments or other regulatory documents.
• Conduct co-monitoring visits with the assigned Sr. CRA by:
  • Verifying that the informed consent process and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensuring the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  • Monitoring data for missing or implausible data.
  • Reviewing site documents for accuracy and completeness as required by FDA regulations, ICH GCP, and Sponsor requirements.
• Assists CRAs in the creation of the site-level personnel transition forms.
• Participate in assigned trial-specific internal, Sponsor, and Investigator meetings.
• Collaborate with cross-functional team members and trial sites throughout all trial phases.
• Perform other duties as assigned.

Job Requirements:

• Bachelor or Associate Degree in a health science field. Equivalent work experience may be substituted for education at TD2’s discretion.
• At least 2 years supporting clinical trial teams in a clinical research environment.
• Solid understanding and working knowledge of clinical trial regulatory requirements.

Required Specialized/Technical Skills:

• Ability to contribute to the team in a remote working environment.
• Experience with ICF (Informed Consent Form) review.
• Strong working knowledge of MS Office products including Word, Excel, and PowerPoint, as well as position specific programs like CTMS, eTMF, and EDC Systems.
• 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 the 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 and monitoring concepts into compelling discussions.
• Able to work efficiently and effectively under tight timelines.

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.

#LI-TD2

#LI-Remote