Clinical Trials Apprenticeship

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Organization:

VICC- Clinical Trials 60

Job Summary:

The Vanderbilt-Ingram Cancer Center (VICC) Clinical Trials Office (CTO) supports physician investigators with the review, preparation, and conduct of industry sponsored, investigator initiated and federally funded clinical research. Clinical research coordinators provide complete study coordination on a range of services, including but not limited to: study feasibility, logistical considerations, IRB preparation and submission, study start-up, regulatory compliance, clinical sample processing, participant recruitment, data management, budgetary review and negotiation as well as financial management.

The Clinical Trials Apprenticeship program is a one-year opportunity working within the VICC CTO. This position will gain broad exposure to many facets of the research life cycle and develop a better understanding of clinical research, data management, regulatory requirements, and patient care services while working on various research-related projects.

As a participant in this apprenticeship, you will spend the first 12 weeks shadowing in various teams within the CTO where you will learn about the fundamental tasks performed by that department. During this time, you will also provide support for administrative duties and clinical support activities as well as have time dedicated to shadow clinical investigators. After completion of the initial 12-week rotation, you will be assigned to assist one or more of the departments for the remainder of the fellowship based upon your interests and department needs.

A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends.

Department/Unit Summary:

Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website -

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Additional Key Elements/ Responsibilities: 

Collaborates with team leaders and Investigators to create goals. Participates in/observes day-to-day departmental activities/operations Communicates effectively orally and in writing to multidisciplinary team members and administrative leadership. Gathers data during assessment phase rotations and gains an understanding of departmental functions Provides data analysis for various projects as assigned Works with financial staff to help project future budgetary needs develops and addressing questions for effective invoicing and to maintain clinical trial billing compliance Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities, and others to review research, source documentation and research procedures Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness, and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports Serves as an advocate for participants by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation. Engages in open and positive communication with study participants and coworkers The responsibilities listed are a general overview of the position and additional duties may be assigned.

CORE ACCOUNTABILITIES:

Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance. Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement. Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements. Team Interaction: Individually contributes to project/ work teams.

TECHNICAL CAPABILITIES:

 Knows the primary resources available to accomplish the job. Can successfully research simple clinical questions pertaining to the functional area. Files and collates trial documentation and reports. Archives study documentation and correspondence. Demonstrates a systematic approach to problem solving.

 Has light experience, training, direct exposure, or past experience with project coordination. Has worked on at least one project in a support role. Collects and collates project related material such as project initiation documents, project status reports, project metrics, and project completion data.

Clearly, effectively and respectfully communicates to employees or customers.

 Applies qualitative and quantitative research methods to perform prepatory, regulatory, and analytic tasking within the life cycle of a study.

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: 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.

Vanderbilt University Medical Center TempForce (TempForce)  was created to connect temporary talent to areas throughout the Medical Center. TempForce places diverse and skilled personnel to departments across the Medical Center. In any given year, TempForce fills a wide variety of temporary requests including pharmacists, administrative/clerical roles, medical assistants and more.

We support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at VUMC for professional growth, appreciation of benefits, and a sense of community and purpose.

Core Accountabilities:

Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.

Core Capabilities :

Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

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Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled

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