Careers in Quality

The Gastrointestinal (GI) Oncology Research Team is seeking a qualified Clinical Trials Associate I to join our rapidly growing
program. Our team has multiple studies across the GI tract but we are primarily focused on colorectal cancer. This position
will assist in active clinical and non-clinical research projects.

JOB SUMMARY:
Performs a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines. Ensures quality of information received.

KEY RESPONSIBILITIES:

• With guidance, assesses and evaluates patient eligibility for approved study to ensure appropriate participants are enrolled.
• Knowledgeable of all active protocols in order to determine if a patient meets specific criteria for eligibility or exclusion from a given study.
• Gathers complete medical history of patient.
• Ensures patient consent forms are completed and appropriate documentation is processed.
• Reviews medical history to determine eligibility status
• Discusses findings with research team
• Processes patient data and runs reports as needed.
• Abstracts and records all patient data essential to the study into appropriate REDCap databases or projects
• Assists in developing an appropriate timeline of tests and required procedures for study participants.
• Inputs all pertinent patient data into database accurately
• Collects and monitors all study patients records to document treatments and outcomes as required by the protocol
• Reports all adverse reactions according to VU and protocol guidelines
• Ensures complete source documentation in record
• Ensures treatment and dates match
• Assists supervisor and other Clinical Trials Specialist with monitoring compliance with protocol and regulations
• Ensures deadlines are met for study
• Follows up with staff about tests and procedures as needed
• Schedules shipping of specimens and samples to meet protocol deadlines.
• Prepares kits for procedures, labels tubes, and handles the times and dates for specimen collection.
• Freezes, spins, separates samples, and cultures as necessary. Mails to designated labs.
• Conducts follow-up of study patients.
• Assists in the continued development of program projects and goals
• Demonstrates initiative for continuous learning, both self-directed and by attendance of offered educational and developmental opportunities. Actively seeks to learn and utilizes knowledge of gastrointestinal malignancies and study processes.
• This list is inclusive but not exhaustive; CTA I is expected to assist in other tasks as they develop
• Organizational Impact: Performs clearly defined tasks and methods described in detail to achieve standardized solutions that impact own performance with regular guidance.
• Problem Solving/ Complexity of work: Follows a well established process to solve routine problems where solutions are clearly prescribed.
• Breadth of Knowledge: Has basic job knowledge of systems and procedures that are common to own job.
• Team Interaction: Individually contributes to the team.

CORE ACCOUNTABILITIES:

• Organizational Impact: Performs clearly defined tasks and methods described in detail to achieve standardized solutions that impact own performance with regular guidance.
• Problem Solving/ Complexity of work: Follows a well established process to solve routine problems where solutions are clearly prescribed.
• Breadth of Knowledge: Has basic job knowledge of systems and procedures that are common to own job.
• Team Interaction: Individually contributes to the team.

CORE CAPABILITIES:

SUPPORTING COLLEAGUES:

• Develops Self and Others: Continuously improves own skills by identifying development opportunities.
• Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas.
• Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner.

DELIVERING EXCELLENT SERVICES:

• Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service.
• Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner.
• Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support.

ENSURING HIGH QUALITY:

• Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards Ensures continuous improvement.
• Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond.
• Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department.

MANAGING RESOURCES EFFECTIVELY:

• Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service.
• Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources.
• Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error.

FOSTERING INNOVATION:

• Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.
• Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action.
• Adapts to Change: Embraces change by keeping an open mind to changing plans and incorporates change instructions into own area of work.