Clinical Research Coordinator

System One is recruiting a Clinical Research Coordinator for a leading site in Rochester, NY. The role supports clinical research protocols by coordinating participant screening, consent, study visits, data and documentation, and study operations under the supervision of the principal investigator and senior research staff.

Responsibilities

Assist in the coordination and execution of clinical research protocols under the supervision of the PI and senior research staff

Conduct screening visits to collect medical history & other information from study participants

Assist with informed consent and enrollment of study participants in accordance with protocol requirements and ethical guidelines

Coordinate and schedule study visits, procedures, and follow-up activities with study participants and clinical teams

Collect, record, and maintain accurate clinical research data and source documentation in compliance with regulatory and institutional standards

Communicate with study participants to provide education, answer questions, and support adherence to study requirements

Monitor study progress and report adverse events, protocol deviations, and other study-related issues to the research team

Adhere to site standard operating procedures (SOPs) and Good Clinical Practice (GCP) guidelines

Draw, process, and ship laboratory specimens, including the handling of dangerous goods, in accordance with regulations (if qualified)

Scan, upload, file, and maintain organized study records and documentation

Apply critical thinking skills to support efficient study operations and problem resolution

Perform other duties as assigned

Preferred

an associate's degree or higher in a health-related field preferred

Basic knowledge of clinical research strongly preferred

Knowledge of GCP, HIPAA, ALCOA principles, FDA regulations, and IATA guidelines strongly preferred

Experience with participant screening and the informed consent process strongly preferred

Proficiency with electronic data capture systems, clinical trial management software, and Microsoft Office (Excel, Word, and PowerPoint) preferred

Medical Assistant (MA) certification preferred

Current CPR/BLS certification preferred

Certification as a Clinical Research Coordinator (e.g., CCRC) or a willingness to obtain certification preferred

Health-Related Degree

Clinical Research Knowledge

GCP

HIPAA

ALCOA Principles

FDA Regulations

IATA Guidelines

Participant Screening

Informed Consent

Electronic Data Capture Systems

Clinical Trial Management Software

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Medical Assistant Certification

CPR/BLS Certification

Clinical Research Coordinator Certification

Benefits

Eligible employees: health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, and voluntary plans

Eligible employees: participation in a 401(k) plan

Company

Specialized technical staffing, recruiting, and outsourced workforce solutions.

Pittsburgh, Pennsylvania, USA

http://www.systemoneservices.com/

Founded in 2008

5001-10000 employees

Qualifications

3+ years experience

High school diploma or equivalent required

Medical terminology & patient care experience required

Strong organizational, time management, and attention-to-detail skills with the ability to manage multiple priorities

Ability to communicate clearly and professionally with diverse populations

Ability to work collaboratively in a fast-paced, team-oriented environment

An associate's degree or higher in a health-related field preferred

Basic knowledge of clinical research strongly preferred

Knowledge of GCP, HIPAA, ALCOA principles, FDA regulations, and IATA guidelines strongly preferred

Experience with participant screening and the informed consent process strongly preferred

Proficiency with electronic data capture systems, clinical trial management software, and Microsoft Office (Excel, Word, and PowerPoint) preferred

Medical Assistant (MA) certification preferred

Current CPR/BLS certification preferred

Certification as a Clinical Research Coordinator (e.g., CCRC) or a willingness to obtain certification preferred

Required skills

Clinical Research, Medical Terminology, Patient Care, Clinical Practice (GCP), HIPAA, ALCOA Principles, FDA Regulations, IATA Guidelines, Participant Screening, Informed Consent, Microsoft Office, Medical Assistant (MA) Certification, CPR/BLS Certification, Clinical Research Coordinator Certification (CCRC)

Preferred skills

Basic knowledge of clinical research strongly preferred, Medical Assistant (MA) certification preferred, Current CPR/BLS certification preferred

Experience

3+ years