Clinical Research Coordinator I

Vanderbilt University Medical Center•Nashville, TN

1d•Onsite

About The Position

Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance with all policies, with some guidance. This role is within the Neurology Admin 20 organization at Vanderbilt University Medical Center (VUMC). VUMC is a leading academic medical center focused on advancing health and wellness through patient care, education, and research.

Requirements

Project Coordination (Fundamental Awareness): 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.
Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Communication (Fundamental Awareness): Clearly, effectively and respectfully communicates to employees or customers.
Clinical Research (Fundamental Awareness): 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.
Relevant Work Experience
Less than 1 year experience
Bachelor's degree

Nice To Haves

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.
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.
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.
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.
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 changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.

Responsibilities

With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations.
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.
Procures equipment and supplies needed to fulfill project requirements.
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.
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
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.
With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance.
Serves as an advocate for human subjects 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.
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
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.
With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required.