CTMS Entry Coordinator

Essential Responsibilities

• Collect, de-identify, enter/transcribe, and transmit/submit clinical data in paper and/or electronic case reports forms (CRFs), including correction and query resolution for assigned investigational drug studies.
• This includes but is not limited to images, lab results, and ECGs.
• Collaborate with Clinical Research Coordinator to ensure data timepoints are accurate and provide query resolution.
• Contact patients in follow-up as needed per protocol.
• Review and utilize protocols as guides for study activities for assigned studies.
• Affiliate with the setup and formatting of study-specific Eligibility, Study Schedules, and Flow Sheets documents per protocol.
• Affiliate with CTMS upkeep, including but not limited to tracking patient visits, IRB re-consents, Serious Adverse Events (SAEs) and Deviations.
• Ensure that data transmissions remain current for assigned studies.
• Provide support and information to onsite and remote monitors as necessary.
• Comply with all applicable regulations, guidelines, and procedures pertaining to data loading, EDC systems, and clinical research.
• Share responsibility with Data Coordinators to identify lab facilities and normal lab values used for assigned studies so that lab certifications can be requested for the study file.
• Attend meetings regarding assigned studies as needed, including site initiation visits, Roster meetings and Forms Committee.
• Communicate as needed with accounts receivable staff regarding transmitted data.

Required Education And Experience

• A high school diploma or equivalent.
• One year of research administrative experience within a healthcare, pharmaceutical, or research organization.
• Knowledge and training in general office administration skills, including computer applications, filing systems, etc.
• Familiarity with medical terminology.
• Strong organizational skills and a sense of timeliness in completing projects.
• Must be detail-oriented and able to understand instructions and work independently.

Best-in-Class Benefits and Perks

• 401(k) retirement savings plan with employer match.
• Generous paid time off and paid holidays.
• Comprehensive medical, dental, and vision coverage and optional insurance options.
• Company-paid life and disability insurance for added financial protection.
• Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one.
• Flexible FSA and HSA plans to support your financial wellness.

About START

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – one of the most effective cancer drugs in medical history.