Clinical Research Coordinator

Overview

The Clinical Research Coordinator will be working in the Department of Psychiatry as the national coordinator for a multisite clinical research study CANalgesia: A National VA clinical trial exploring cannabis-based therapies for chronic neuropathic pain in veterans. The study aim: to compare the safety and efficacy of THC oral solution, CBD oral solution, THC/CBD oromucosal spray, compared to matching placebos in treating Veteran Chronic Neuropathic Pain (CNP).

The national coordinator will oversee project managers and manage all study goals and tasks, assuring all aspects of the project are on track and meet all regulatory requirements. CRC will also be working on different studies including clinical trials for the PI that include screening, consent, blood drawing, hemodynamic monitoring, processing of blood drawing as specified in protocols, and follow ups. Study protocol may involve processing of blood samples as well as handling and shipment procedures. For additional study specific procedures and educational interventions, CRC will be trained in the study protocols before execution.

Carries out research within the scope of the established study protocol. Adheres to all human subject’s regulations as defined by Yale University and the federal government that pertain to research studies. Develops criteria for admission of study subjects based on goals and objectives of project. Determines potential sources of funding and prospective partnerships. Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder. Develops original HIC/IRB submissions.  Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols.  Plans and implements changes. Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding. Responsible for the documentation and transmission of study data.  Ensures that report forms are accurately documented and completed in a timely manner at each site location. Works independently to develop manage and organize multi-site studies.  Serves as primary coordinator between university, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources. Performs descriptive and multivariate statistical analyses of data, using computer software. Designs and implements quality control measures to ensure accurate collection and processing of data. Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.

Required Skills and Abilities

1. Clinical Research Proficiency and Compliance: Proven experience with clinical studies.
2. Self-Motivation, Organization, and Detail-Orientation: Demonstrates self-motivation, independence, consistency, and reliability. Shows excellent attendance, punctuality, and organizational skills. Pays close attention to detail and communicate effectively.
3. Effective Under Pressure with Communication and Leadership: Proven ability to work efficiently and independently under pressure, prioritizing tasks effectively. Demonstrates strong oral and written communication skills, along with leadership qualities.
4. Technical Proficiency in Research Tools: Exhibits proficiency in Microsoft Office, Experience with electronic data collection tools such as iPads and software like Endnote and Adobe.

Preferred Skills and Abilities

Project management experience preferred. Experience working in a VA. Experience preparing IRB protocols, amendments, and progress reports. Experience developing and managing original HIC/IRB submissions; collaborates with PIs on major revisions based on knowledge of science and research goals; plans and implements changes. Experience with SPSS and REDCap.

Principal Responsibilities

1.   Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters.
2.   Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements.
3.   Critically evaluates information gathered from multiple sources - research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials.
4.   Analyzes data with standard methods, interprets the results, and provides written summary and reporting of data analysis. Develops reporting modules, ad-hoc reports and related reporting tools. Conducts research, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases
5.   Develops and maintain documentation and libraries on key processes.
6.   Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations. 
7.   Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members.
8.   Performs or assists with research compliance audits or self-assessments.
9.   Communicates effectively the perspective of business opportunities, needs, and risks.

Required Education and Experience

Bachelor’s degree in a related field and one year of related work experience in the same job family or an equivalent combination of experience and education.  Must be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis.

Salary Range

$55,000.00 - $85,000.00

Location

950 Campbell Avenue, Bldg 01, West Haven, Connecticut