Clinical Research Coordinator II-Movement Disorders

Montgomery College; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Vanderbilt Health seeks a Clinical Research Coordinator to support regulatory submissions, oversee study documentation, and coordinate multi-site trials. You will ensure adherence to protocols and regulatory requirements while collaborating with investigators, sponsors, and research staff.

The role emphasizes data integrity, participant safety, and timely study execution within a leading academic health system. A Bachelor's degree and 1 year of related experience are preferred.

Qualifications

• Experience in coordinating IRB submissions and regulatory documents.
• Familiarity with regulatory requirements for clinical trials and report writing.
• Bachelor's degree or higher required; 1 year of relevant work experience preferred.

Responsibilities

• Prepare and process IRB proposals, amendments, and adverse event reports.
• Maintain essential trial documentation for regulatory authorities and sponsors.
• Support site visits, data collection, and budgeting for clinical trials.
• Coordinate and track project activities to ensure timely delivery and compliance.

Skills

Clinical Research

Study Design

Project Coordination

Communication

Education

Bachelor's

Job description

Discover Vanderbilt Health: With eight hospitals and over 180 clinics, we are the region’s largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world‑class care to the people of the Mid‑South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you’ll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region.

Organization: Neurology Admin 20 Job Summary: 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 within all policies, under occasional guidance. .

KEY RESPONSIBILITIES

• Proficiently 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
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available 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
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
• Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
• 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
• 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.
• Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
• 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, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
• 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 ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial
• Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel

TECHNICAL CAPABILITIES

Clinical Research (Novice)

Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.

Study Design & Conduct (Novice)

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

Project Coordination (Novice)

Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories.

Communication (Novice)

Clearly, effectively and respectfully communicates to employees or customers.

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.

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.

Position Qualifications

Responsibilities:

Certifications : Work Experience : Relevant Work Experience Experience Level : 1 year Education : Bachelor's

This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well‑being and professional growth. Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled. PEOPLE ARE AT THE HEART OF ALL WE DO. Great health care takes great people. We’re looking for like‑minded individuals driven to make a difference. We invite you to explore careers at Vanderbilt Health, where we value collaboration, embrace continuous learning and foster an environment where everyone can thrive. We’re the largest private employer in Middle Tennessee, with a growing team and an expanding footprint across towns and communities throughout the region. We employ more than 43,000 people who work in inpatient and outpatient clinical care, research and graduate medical education. Our employees also serve in critical supporting roles in administration, information technology and informatics, finance, legal and community affairs, communications and marketing, fundraising, groundskeeping and facilities, and many other departments. Our growing academic health system has more than 2,100 licensed hospital beds at eight hospitals: Vanderbilt University Hospital Monroe Carell Jr. Children’s Hospital at Vanderbilt Vanderbilt Psychiatric Hospital Vanderbilt Stallworth Rehabilitation Hospital Vanderbilt Bedford Hospital Vanderbilt Clarksville Hospital Vanderbilt Tullahoma-Harton Hospital Vanderbilt Wilson County Hospital Vanderbilt Health is the Mid‑South's largest provider of specialty care, with hundreds of outpatient clinic and surgical locations throughout the region, and Tennessee’s only National Cancer Institute‑designated Comprehensive Cancer Center for adults and children. We are one of the nation's busiest critical care centers, home to Middle Tennessee’s only Level 1 Trauma Center and Burn Center for adults and children, and Middle Tennessee’s only Level IV Neonatal Intensive Care Unit. We are the nation’s largest transplant center, and last year we performed the most heart transplants than any center worldwide. Vanderbilt Health is an epicenter for biomedical research, winning over $1 billion in annual research awards from government, industry, foundations and donors. We are also a national leader in medical training and education, with the largest clinical training center in the Mid‑South and the only training center in Tennessee for many adult and pediatric specialties. We’re honored to be consistently considered among the nation’s best hospitals for quality, safety and patient satisfaction. Three of our hospitals — Vanderbilt University Hospital, Vanderbilt Psychiatric Hospital and Vanderbilt Wilson County Hospital — have been awarded a Five‑Star Quality Rating from Medicare. We support each other and encourage excellence among every member of our workforce. High‑achieving employees stay at Vanderbilt Health for professional growth opportunities, competitive compensation and benefits, and a sense of community and purpose. Join us in advancing health care.

Our vision: The world leader in advancing personalized health Our mission: Personalizing the patient experience through our caring spirit and distinctive capabilities