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Clinical Trials Specialist
Denver Drug Development Unit
- Clinical Operations
Sarah Cannon Research Institute (SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
Summary of Key Responsibilities:
Plan the execution and monitor the completion of complex Phase I assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of drug development data operations, clinical trial sponsor and study team.
Duties and Responsibilities:
Duties include but are not limited to:
- Leads the execution of trials for the research team.
- Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 days of patient visits.
- Confirm patient eligibility and discuss discrepancies with nursing staff and physicians
- Verify screening procedures are performed within the protocol specified window
- Enroll 1-2 patients per week
- Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record
- Planning and tracking of all assigned clinical activity in the lifecycle phases of the start up, interim and close out.
- Educates Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
- Creates study specific tools for source documentation including eligibility worksheets, screening checklists and intense sampling worksheets capturing vitals, ECGs, blood and tumor sampling
- Ensures pharmacist has clinical and drug supplies.
- Interfaces with laboratory technician for lab kits and processing.
- Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations.
- Participates in monitor visits monthly for each trial assigned.
- Reviews source documentation and queries for missing documentation.
- Maintains case report forms tracking management database.
- Reviews trial data for clinical relevance and answers appropriate queries.
- Apprises research scientists and Drug Development Management team of all study specific medical issues for guidance.
- Assists sponsor and US FDA audit teams.
- Reviews and responds to any monitoring and auditing findings and escalates issues defined by Project Manager.
- Archives study documentation and correspondence per company policy.
- Participates in sponsor meetings when applicable.
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
- Adhere to professional standards and SOP's established for clinical research.
- Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement".
- Monitors and maintains accurate and complete information concerning study cohort, slot allocation, toxicity and response on trial.
- Required to be present in weekly department meetings to review every trial and patient in the DDU.
- Responsible for reporting on dates of cohorts opening, number of slots allocated to SCRI as well as other sites and dates of all patients starting treatment.
- Timely and accurate completion of Serious Adverse Events approximately 2 per week.
- Assist to ensure physician oversight by updating on protocol issues prior to updating the sponsor and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events.
- Intense sponsor interaction including daily phones calls and e-mails to update on patient status as well as toxicity and response.
- Participant in weekly teleconferences with sponsors to update on patients including last visit, any toxicity, and response. Responsible for sending notification out to department before and after calls to update staff.
- Responsible for noting any significant toxicity, particularly protocol defined dose limiting toxicities and notifying drug development management team as well as sponsor.
- Responsible for following patient's response to treatment according to RECIST criteria in real time to assist in treatment decisions.
- Responsible for ensuring Site Visit Outlines are accurate for assigned trials as well as input reminders for nursing staff to minimize clinic error.
- Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
- During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
- Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
- Must have an understanding of analyze clinical trial data.
- Knowledge of FDA guidelines and GCP is required.
- Skills: The proficiency to perform a certain task
- Professional writing and communication skills.
- Organizational and prioritizing capabilities.
- Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel.
- Abilities: An underlying, enduring trait useful for performing duties
- Ability to work independently in a fast paced environment.
- Interpersonal skills, detailed-oriented and meticulous.
Minimum Required: High School Diploma or GED
Preferred: Bachelor's degree in nursing, pharmacy or other science related field or combination of equivalent education and experience.
- 3 years experience in healthcare, research or other science related field.
- 1 year experience in planning and managing clinical trial processes
- Or equivalent experience
- Research Professional Certification - CCRP or exam eligibility preferred.
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