Yale University
Overview
Within the Department of Neurology’s Clinical Research Office and reporting to the Research manager, the Clinical Research Coordinator (CRC) will lead efforts in the execution of research studies within the scope of the established study protocol(s) assigned. These activities include, but are not limited to, study start up, patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will also be the primary point of contact on all communications and management of all study documentation. The CRC will have direct patient contact and will be responsible for managing all clinical trials primarily in the Epilepsy Division. Some studies may require on call rotational support on weekends/after normal business hours. Subjects will be recruited mainly on the New Haven campus but may be recruited from other Yale Neurology locations within the state of Connecticut. Salary Range $65,000.00 - $101,000.00
Note:
This description contains information about the role, expectations, and requirements as provided. Responsibilities
Lead execution of research studies per established protocols, including start-up, screening, eligibility, registration, and subject milestones. Serve as the primary point of contact for communications and management of study documentation. Maintain direct patient contact and oversee clinical trials in the Epilepsy Division; provide on-call rotational support as needed. Recruit subjects primarily at the New Haven campus with potential recruitment at other Yale Neurology locations in Connecticut. Required Skills And Abilities
Excellent verbal and written communication skills, with strong organizational and time management abilities; ability to prioritize tasks with competing deadlines. Careful attention to study requirements, regulatory compliance, and accurate documentation; ability to prepare and submit regulatory and maintenance documents for the life of a study/trial. Skill in obtaining informed consent and conducting related subject interactions, including collaborating with clinical providers; ability to track multiple occurrences and outcomes and document promptly. Independence and management skills with critical thinking and problem solving to ensure compliant study execution and adherence to sponsor policies. Exemplary attendance and flexibility to support study needs and recruitment; ability to work collaboratively with other clinical research coordinators. Preferred Education, Experience And Skills
Master’s degree in a health or research-related discipline and two years of related work experience in a similar job family. Strongly prefer candidates who can work with minimal supervision in a team setting and are receptive to new processes. Familiarity with neurological clinical research is strongly preferred. Proven experience with EPIC and OnCore systems and IRB submissions. Principal Responsibilities
Compare protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols; document congruency. Facilitate and assist with resolution of any inconsistencies between funding proposals and approved protocols. Serve as liaison between Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. Attend meetings and present issues identified during congruency review. Provide technical assistance to investigators and their staff; offer analytical support related to protocol/grant congruency. Monitor federal and state regulations for new guidance or updates; stay knowledgeable to ensure compliance with congruency review and reporting requirements. Develop, implement, and manage internal practices that ensure compliance with federal requirements. May perform other duties as assigned. Required Education and Experience: Bachelor’s degree in a relevant field and a minimum of 3 years of related research support experience; or equivalent. Background Check Requirements
All candidates for employment will be subject to pre-employment background screening, which may include motor vehicle checks, DOT certification, drug testing, and credit checks based on the position description and job requirements. Offers are contingent upon successful completion of the background check. For more information, see the background checks resource on Yale Careers. Health Requirements
This role is a healthcare worker position with potential direct or indirect exposure to patients, human research subjects, or infectious materials. Health requirements may include MMR, varicella, TB screening, COVID vaccination per University policy, hepatitis B vaccination or immunity, and annual flu vaccination. Posting Disclaimer
Salary offers are determined by qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and market conditions. The description is a representative summary and not a complete list of duties. Employees may be assigned duties through their hiring department. The University is committed to equal opportunity and does not discriminate in admissions, education, or employment on the basis of sex, sexual orientation, gender identity or expression, race, color, national origin, religion, age, disability, veteran status, or other protected statuses. Inquiries regarding Yale's Policy Against Discrimination and Harassment may be directed to the Office of Institutional Equity and Accessibility (OIEA). Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Higher Education
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Within the Department of Neurology’s Clinical Research Office and reporting to the Research manager, the Clinical Research Coordinator (CRC) will lead efforts in the execution of research studies within the scope of the established study protocol(s) assigned. These activities include, but are not limited to, study start up, patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will also be the primary point of contact on all communications and management of all study documentation. The CRC will have direct patient contact and will be responsible for managing all clinical trials primarily in the Epilepsy Division. Some studies may require on call rotational support on weekends/after normal business hours. Subjects will be recruited mainly on the New Haven campus but may be recruited from other Yale Neurology locations within the state of Connecticut. Salary Range $65,000.00 - $101,000.00
Note:
This description contains information about the role, expectations, and requirements as provided. Responsibilities
Lead execution of research studies per established protocols, including start-up, screening, eligibility, registration, and subject milestones. Serve as the primary point of contact for communications and management of study documentation. Maintain direct patient contact and oversee clinical trials in the Epilepsy Division; provide on-call rotational support as needed. Recruit subjects primarily at the New Haven campus with potential recruitment at other Yale Neurology locations in Connecticut. Required Skills And Abilities
Excellent verbal and written communication skills, with strong organizational and time management abilities; ability to prioritize tasks with competing deadlines. Careful attention to study requirements, regulatory compliance, and accurate documentation; ability to prepare and submit regulatory and maintenance documents for the life of a study/trial. Skill in obtaining informed consent and conducting related subject interactions, including collaborating with clinical providers; ability to track multiple occurrences and outcomes and document promptly. Independence and management skills with critical thinking and problem solving to ensure compliant study execution and adherence to sponsor policies. Exemplary attendance and flexibility to support study needs and recruitment; ability to work collaboratively with other clinical research coordinators. Preferred Education, Experience And Skills
Master’s degree in a health or research-related discipline and two years of related work experience in a similar job family. Strongly prefer candidates who can work with minimal supervision in a team setting and are receptive to new processes. Familiarity with neurological clinical research is strongly preferred. Proven experience with EPIC and OnCore systems and IRB submissions. Principal Responsibilities
Compare protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols; document congruency. Facilitate and assist with resolution of any inconsistencies between funding proposals and approved protocols. Serve as liaison between Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. Attend meetings and present issues identified during congruency review. Provide technical assistance to investigators and their staff; offer analytical support related to protocol/grant congruency. Monitor federal and state regulations for new guidance or updates; stay knowledgeable to ensure compliance with congruency review and reporting requirements. Develop, implement, and manage internal practices that ensure compliance with federal requirements. May perform other duties as assigned. Required Education and Experience: Bachelor’s degree in a relevant field and a minimum of 3 years of related research support experience; or equivalent. Background Check Requirements
All candidates for employment will be subject to pre-employment background screening, which may include motor vehicle checks, DOT certification, drug testing, and credit checks based on the position description and job requirements. Offers are contingent upon successful completion of the background check. For more information, see the background checks resource on Yale Careers. Health Requirements
This role is a healthcare worker position with potential direct or indirect exposure to patients, human research subjects, or infectious materials. Health requirements may include MMR, varicella, TB screening, COVID vaccination per University policy, hepatitis B vaccination or immunity, and annual flu vaccination. Posting Disclaimer
Salary offers are determined by qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and market conditions. The description is a representative summary and not a complete list of duties. Employees may be assigned duties through their hiring department. The University is committed to equal opportunity and does not discriminate in admissions, education, or employment on the basis of sex, sexual orientation, gender identity or expression, race, color, national origin, religion, age, disability, veteran status, or other protected statuses. Inquiries regarding Yale's Policy Against Discrimination and Harassment may be directed to the Office of Institutional Equity and Accessibility (OIEA). Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Higher Education
#J-18808-Ljbffr