What are the responsibilities and job description for the Clinical Research Assistant - On-Site position at XingImaging, LLC?
Position Overview
This is a regular, full-time, on-site position based at our New Haven, Connecticut facility.
The Clinical Research Assistant supports the execution of clinical research activities by collaborating closely with various members of a multi-disciplinary research team as well as research participants to ensure studies are conducted safely, accurately, and in compliance with regulatory and protocol requirements. This role involves direct interaction with participants, support of research visits, and hands-on involvement for biological specimens and/or radiopharmaceutical handling and transport. The Clinical Research Assistant is integral to the day-to-day operations of clinical research within the XingImaging research facility.
About XingImaging
XingImaging, a subsidiary of MITRO, is a leading provider of advanced research imaging and radiopharmaceutical services. Our New Haven facility offers a comprehensive range of services, including clinical trial activities and support, advanced imaging, radiotracer manufacturing, and leading imaging analysis services. We are committed to delivering high-quality imaging solutions and accelerating the development of life-saving treatments.
Key Responsibilities
· Support clinic staff with research participant flow and study-related procedures, with IRB-approved protocols, including participant check-in, direct interaction, and accompaniment to on-site and off-site study-related appointments.
· Maintain strict adherence to participant privacy, confidentiality, and human subject protection requirements, including safeguarding protected health information (PHI) in accordance with ICH GCP, IRB approvals, and institutional policies.
· Obtain and accurately document protocol-specified assessments such as vital signs, ECGs, and phlebotomy, in accordance with study protocols, delegation requirements, and clinic procedures.
· Perform laboratory-focused activities, including the collection, processing, labeling, and preparation of blood and other biological specimens in accordance with protocol requirements and laboratory manuals.
· Maintain accurate source documentation and chain-of-custody for all specimens and study materials handled.
· Transport biological specimens and/or radiopharmaceuticals to and from qualified vendors in compliance with safety, regulatory, and institutional requirements.
· Assist with imaging file upload and assist with timely query resolution when applicable.
· Provide general study operations support, including scheduling assistance, visit coordination, procedure and imaging support, and administrative tasks.
· Communicate effectively with clinical, imaging, and other research team members to support efficient study execution, protocol compliance, and positive participant experience.
· Perform additional duties as assigned by the direct supervisor and/or Clinic Management.
Qualifications and Requirements
· Bachelor’s degree in a health, life sciences, or related field; Equivalent clinical or research experience may be considered.
· Prior experience in clinical research, healthcare, or laboratory setting.
· Demonstrated ability to perform protocol-driven tasks with a high level of accuracy and attention to detail.
· Experience or training in vital signs, ECGs, and phlebotomy.
· Familiarity with biological specimen handling, including collection, processing, labeling, and chain-of-custody documentation.
· Ability to follow SOPs, study protocols, and safety procedures in a regulated research environment.
· Strong organizational, documentation, and time-management skills in a fast-paced clinical setting.
· Effective verbal and written communication skills and the ability to work collaboratively with multidisciplinary clinical, imaging, and research teams.
· Ability to maintain professionalism, discretion, and situational awareness when interacting with research participants and clinical staff.
Preferred but not required
· Prior experience working on IRB-approved clinical research studies, particularly in neurodegenerative disorders, such as Alzheimer’s Disease, Parkinson’s Disease, and similar disorders.
· Working knowledge of ICH GCP guidelines, human subject protection principles, and IRB requirements, or willingness to complete required training prior to study involvement.
· BLS certification
Unique Department Requirements
· Exposure to ionizing radiation
· Biohazard exposure to human blood and bodily fluids
· Ability to lift and move up to 50 lbs (for heavy equipment and patient positioning)
· Ability to Travel between XingImaging and external vendors as required to accompany research participants and to transport biological specimens and/or radiopharmaceuticals, either on foot
or via company-approved transportation, in accordance with safety procedures and institutional policies.
· Intermittent evening and weekend work may be required
PLEASE NOTE
Please note that since this is position is fully onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building’s landlord.
What We Offer
· Competitive Salary
· Comprehensive Health Insurance Plan
· Long-Term Disability
· Life Insurance
· Retirement Plan
XingImaging, a Mitro Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic information, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.