Title:

Clinical Research Coordinator at the Cardiovascular Data Science (CarDS) Lab.

Job Description:

This role offers an opportunity to engage in a range of exciting projects aimed at enhancing patient care with emerging technologies. Responsibilities will include project coordination and recruitment in clinical trials focusing on AI technologies, spanning wearable devices and AI-powered cardiovascular diagnostics. The position will enable engagement in research aimed at transforming clinical care.

Position Focus:

The team at CarDS lab represents a multidisciplinary and exciting group of scientists, postdoctoral trainees, and graduate and undergraduate students across Yale, with broad collaboration with informatics, computer science, and statistics groups at Yale and several leading institutions nationally. Our team has developed novel tools to measure and improve the quality of care within electronic health records, and designed novel AI software solutions for the early diagnosis of several cardiovascular disorders. The research in the lab allows unique collaborative opportunities with industry and health technology partners. For additional information about CarDS lab, please visit www.cards-lab.org/.

Under the supervision of the Director of CarDS and exercising wide latitude to practice independent judgment and initiative, the Clinical Research Coordinator will be responsible for overseeing, planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include but are not limited to the oversight of patient screening, eligibility determination, registration, administering surveys, and other protocol and subject milestones. The position works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner, exercising respectfulness and professionalism. The Clinical Research Coordinator will have direct patient contact and is responsible for managing and performing the clinical and operational aspects of low to moderately complex clinical trials and non-therapeutic trials. 

Responsibilities:

• Serve as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non-therapeutic trials. Serves as a supporting clinical research coordinator to CRC/CRN II and Sr. CRC/CRN for highly complex protocols.  

• Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies and non-therapeutic trials. 

• Contribute to study feasibility reviews and make recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes for low to moderately complex clinical trials and non-therapeutic trials.  

• Ensure low to moderately complex study protocols are adhered to, oversee the maintenance of accurate documentation, and recruitment of study participants, and ensure regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements.

• Identify instances of noncompliance and deviations from protocol and work with the manager to analyze and advise noncompliance and deviations to the appropriate parties.

• Advise Principal Investigator oversight on low to moderately complex clinical trials and non-therapeutic trials by providing updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required.

• Analyze documents and convey study data on low to moderately complex clinical trials and non-therapeutic trials. Coordinate with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner.

• Oversee the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations on low to moderately complex clinical trials and non-therapeutic trials.

• Assess trial execution for assigned low to moderately complex trials and non-therapeutic trials and identify areas that need improvement or that require correction and provide education and/or recommendations, as needed.

• Collaborate with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensure implementation and adherence to stated plan for low to moderately complex trials and non-therapeutic trials. 

• Collaborate with the Quality Education Unit to contribute to the design of CRC training and continuing education.

• Participate in interim monitoring visits and internal audits.

• Monitor, interpret, and communicate federal and state regulations, and local policies for new guidance, updates, or policies.

• Perform other duties as assigned.

Required Education and Experience:

1. Bachelor’s degree in a health-related discipline, or other related field and one (1) year of clinical research experience, or the equivalent combination of education or experience. Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required. Experience must indicate the ability to work with minimal supervision in a team environment.

2. Demonstrated excellent organizational ability and time management skills. Ability to meet deadlines within a high-volume environment.

3. Strong communication skills, the ability to communicate effectively and diplomatically in written and verbal forms with internal and external contacts, patients, faculty, and staff. 

4. Superior computer skills, including proficiency in Microsoft Word, Outlook, Excel, and PowerPoint. Proven ability to design spreadsheets and graphics and willingness to learn new technologies.

5. Well-developed interpersonal skills and ability to form strong working relationships with faculty, staff, patients, and other stakeholders. Takes ownership of providing superior customer services.  

6. Well-developed problem-solving skills. Proficient in framing an issue, identifying and evaluating potential solutions, and seeing issues through to resolution.   

Preferred education, experience and skills:

Experience working with confidential information and coordinating patient studies. Special skills desired include the ability to be flexible with change and to function at a high level of organization and prioritization combined with strong attention to detail and accuracy. Ability to problem solve and work independently with minimal supervision. As well as a proven ability to learn new skills/techniques and quickly integrate them into polished deliverables. 

To apply for this position, please reach out to us with your CV at cards@yale.edu