Apply Now
Job description
-Under the direction of the research manager and PI, the CRC leads the research team in the execution of trials 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. Proven ability to coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline with demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale team and potential study sponsor.
Essential Duties
1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols.
2. Documents established congruency between funding proposals and approved protocols.
3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols.
4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
5. Attends meetings and presents issues when necessary that were identified during congruency review.
6. Serves as a resource and provides technical assistance to investigators and their staff.
7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed.
8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform other duties as assigned.
Required Education and Experience
Bachelor’s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.
Required Skill/Ability 1:
Proven ability to lead a research team in the execution of trials within the scope of the established study protocol and easily adapts to research in multiple disease areas; Bilingual, Spanish, and English. Demonstrated experience with pediatric populations with neuro-developmental disorders.
Required Skill/Ability 2:
Demonstrated skill in meticulous attention to study requirements, regulatory constraints, and accurate follow-through. Ability to prepare and submit regulatory documents and maintenance requirements for the life of the trial(s).
Required Skill/Ability 3:
Thoroughly skilled in obtaining informed consent and related research subject interactions and requirements. Proven ability to track multiple occurrences and outcomes and document the same in a timely manner. Exceptional organizational skills.
Required Skill/Ability 4:
Demonstrated independence and management skills among multiple study sites. Demonstrated ownership of communication requirements necessary for effective oversight and conduct of human clinical research utilizing multiple electronic data capture systems.
Required Skill/Ability 5:
Demonstrated ability and skill for data management and timely execution into multiple databases. Demonstrated ability and skill for specimen collection, laboratory processing, and vital sign execution.
Preferred Education, Experience and Skills:
Bachelor’s in health or research-related discipline and 3 years of related work experience in a similar job family. Ability to work with minimal supervision in a team atmosphere and receptiveness to direction regardless of disease area. Working knowledge of EDC systems and adoption of new data management systems. EKG capabilities and phlebotomy skills are strongly preferred, Bilingual.
Preferred Licenses or Certifications NOT REQUIRED
BLS, AED Certification; Clinical Coordinator Certification (SoCRA or equivalent).
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit “Learn about background checks” under the Applicant Support Resources section of Careers on the It’s Your Yale website.
Health Care Worker
This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
JO-2506-170853