Clinical Research Coordinator II

Position Overview

This is a regular, full-time, on-site position based at our New Haven, Connecticut facility.

The Clinical Research Coordinator (CRC) will oversee the execution of research studies according to established study protocols. Responsibilities include study start-up, screening, eligibility determination, registration, and tracking various protocol and subject milestones. The CRC will have direct contact with research participants, manage multiple clinical research projects/trials, and serve as a backup to other clinical research coordinators within the team.

About Mitro

MITRO Biotech Co., Ltd. is a molecular imaging contract research organization (MI-CRO) company in China. MITRO provides outstanding contract research for new drug development using radiolabeling and molecular imaging techniques. MITRO provides integrated solutions, including evaluation of potential therapeutics, biodistribution, pharmacokinetics and pharmacodynamics. MITRO provides translational research using a wide range of non-clinical through Phase 0 clinical trial services. MITRO's focus includes but is not limited to: cancer, coronary heart disease, Alzheimer disease, epilepsy, Parkinson disease, rheumatoid arthritis, diabetes, gene expression, and stem cell research.

MITRO Biotech Co., Ltd.'s acquisition of XingImaging, LLC in September 2023 brought with it an active expansion to offer early through late phase PET clinical imaging and clinical services to industry sponsors and researchers for advancement of new imaging tracers for evaluation of diagnostic indicators, disease progression, and therapeutic medicines.

Key Responsibilities:

· Serve as the lead and/or co-coordinator for moderately complex, Phase I-IV clinical trials in a clinical site-based setting from study initiation through close-out.

· Support study visits execution of moderately complex participant visits including screening, informed consent, neuropsychological testing, vital sign collection, acquiring ECGs, phlebotomy and procedural support (e.g., lumbar punctures, skin biopsies, brain imaging).

· Perform biological specimen processing, including blood, urine, CSF, and other protocol-required samples, following study-specific laboratory manuals and Good Clinical Practice (GCP) standards.

· Coordinate and prepare outbound sample shipments using dry ice, ambient, or refrigerated packaging systems according to IATA regulations.

· Work closely with local and central laboratories to ensure accurate manifest completion, courier scheduling, and timely shipment tracking.

· Monitor and document temperature excursions, equipment failures, or deviations, escalating to clinic management and QA promptly.

· Assist with source documentation, eCRF data entry, and query resolution.

· Manage and monitor regulatory compliance, including protocol deviations, safety event reporting, and participating in monitoring visits in collaboration with regulatory personnel.

· Scheduling of participant visits for assigned studies, including coordination of travel logistics, stipend processing, and site calendar review to ensure a seamless and positive participant experience.

· Provide cross-coverage support for other CRCs and clinical studies during PTO or workload surges, aligned with training and delegated responsibilities.

· Provide mentorship and training to Clinical Research Coordinators I and study support staff to reinforce their professional development and ensuring adherence to Good Clinical Practices (GCP) and protocol procedures.

· Perform additional duties as assigned by the direct supervisor and/or Clinic Management.

Qualifications and Requirements:

• Bachelor's degree in science or health related field &/or minimum 3-5 years equivalent experience in a related clinical research or healthcare position, or equivalent combination of education and relevant experience.

• Competent understanding of Good Clinical Practices (GCP), Good Documentation Practices (GDP), and clinical trial conduct.

• Working knowledge and practical laboratory experience with biological sample collection, processing, storage, and shipping within clinical trial operations.

• Strong interpersonal skills with a proven ability to communicate effectively across multidisciplinary teams.

• Highly organized with excellent attention to detail and ability to manage multiple complex studies independently.

• Knowledge of clinical terminology, protocol interpretation, and site operational workflows.

• Proven problem-solving, critical decision making and professional judgement

• Demonstrates integrity, accountability, and a high standard of ethical conduct.

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Teams).

Preferred but not required:

• Experience supporting clinical trials in neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, or related tauopathies.

• Familiarity with nuclear medicine imaging modalities, including PET-CT, SPECT-CT, and MRI.

• Basic Life Support (BLS) certification

• IATA Dangerous Goods Certification (Category B)

• GCLP Certification (Good Clinical Laboratory Practice)

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)

• Intermittent evening and weekend work may be required
• Travel to meetings 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.