Job Description
**Covid-19 Vaccination Required**
Job Title:
Clinical Research Coordinator
Reports To:
Senior Director, Strategic Initiatives - Theranostics
Department
Clinical Research
Prepared Date:
10/1/2025
FLSA Status:
Non-Exempt
Salary Range: $30-$36/hr
Summary:
At East River Medical Imaging, our mission is to consistently provide the highest quality and availability of diagnostic imaging with compassion and comfort for our patients. Our team works together to deliver exceptional patient experience across all diagnostic, treatment, and research services. The Clinical Research Coordinator (CRC) supports the conduct of clinical trials focused on investigational radiopharmaceuticals and radioligand therapies (RLTs). The CRC is responsible for coordinating trial operations including participant recruitment, informed consent, scheduling, data management, and regulatory documentation. This role ensures compliance with study protocols, Good Clinical Practice (GCP), and institutional policies. Working closely with investigators, technologists, nurses, and sponsors, the CRC facilitates efficient and high-quality research while maintaining participant safety and confidentiality.
Duties
- Recruit, pre-screen, and consent research participants in accordance with protocol eligibility criteria.
- Schedule participant visits, imaging procedures, and follow-up assessments; coordinate logistics with research staff and clinical teams.
- Maintain accurate study records including source documents, case report forms (CRFs), and electronic data capture (EDC).
- Track participant progress, visit completion, and ensure timely data entry and query resolution.
- Assist in collection, processing, and shipment of biospecimens per protocol requirements.
- Support documentation of investigational product use and accountability records as reported by licensed staff.
- Prepare and submit IRB/ethics applications, amendments, continuing reviews, and study closeouts.
- Ensure compliance with GCP, ICH, FDA, EMA, IAEA, HIPAA, and institutional radiation safety regulations.
- Support site monitoring visits, sponsor audits, and inspections with accurate and timely documentation.
- Serve as liaison among investigators, study staff, sponsors, CROs, and regulatory bodies.
- Participate in team meetings, protocol training, and cross-functional coordination to support smooth trial operations.
- Support internal policy & procedure updates with the Senior Director.
Competencies:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Strong organizational and project management skills with the ability to manage multiple studies simultaneously.
- Excellent written and verbal communication skills for interaction with participants, investigators, sponsors, and research staff.
- High attention to detail and accuracy in documentation.
- Ability to work independently and as part of a team.
- Strong problem-solving and adaptability skills.
- Excellent organizational, communication, and interpersonal skills.
Qualifications:
- At least 2 years of experience in clinical research or human subjects research required.
- 3 years of experience in healthcare, direct patient care preferred.
- Prior experience in oncology, radiology, or related research preferred.
- Phlebotomy/basic laboratory experience strongly preferred
- Familiarity with PET imaging, radiopharmaceuticals, or nuclear medicine research strongly preferred.
- Knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements required.
Education/Experience:
Bachelor's degree in life sciences, healthcare administration, or a related field required; Advanced degree preferred.
Computer Skills:
Proficiency with electronic health records, clinical trial management systems (CTMS), and Microsoft Office.
Certificates and Licenses:
- Basic Life Support (BLS) certification required within 90 days of hire.
- Certification in shipping and handling of specimens within 30 days of hire required.
- SOCRA Certified Clinical Research Professional (CCRP) or ACRP Certified Professional (ACRP-CP/CCRC) preferred.
Supervisory Responsibilities:
This job has no supervisory responsibilities.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
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Job Tags
Full time, Work at office,