Clinical Research Coordinator II

New Haven, Connecticut, United States | Full-time

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Overview:

Coordinates and administers research study associated activities. Assists in project planning. Ensures the smooth and efficient day-to-day operation of research and data collection activities. This position requires frequent close interactions with subjects, physicians and other staff members.  Complete, accurate and timely reporting of data is essential.

Responsibilities: 

  • Participates in clinical research studies from study initiation through close-out and archiving.
  • Under the direction of the Principal Investigator, undertakes all essential, operational and patient care responsibilities associated with day to day clinical trial and study visit activities following good clinical practice guidelines.
  • Recruits, screens and enrolls subjects according to specific protocol requirements
  • Works closely with the protocol and completes the consenting process, along with inclusion/exclusion criteria to determine eligibility of study participants.
  • Develops, maintains and version controls source documents and tracking logs relevant to the study.
  • Completes study visit activities including EKGs, phlebotomy, taking vital signs, laboratory sample processing and shipment.
  • Conducts adverse event information collection concomitant medication review, and neuropsychological scale measurements.
  • Manages study monitoring visits; completes the study Case Report Form (CRF).
  • Ensures diagnostic specimens are packaged per IATA (International Air Transport Association) guidelines
  • Abides by Good Clinical Practices (GCP) and complies with all company Standard Operating Procedures (SOP).
  • Assists with IRB and Regulatory submissions

 Qualifications  

  • Bachelor’s Degree in a science or relevant field and/or equivalent related work experience
  • Knowledge of Good Clinical Practices (GCP) and other Regulations
  • Ability to perform EKGs, vital signs, and phlebotomy
  • Understanding Phases I-IV drug development process
  • Must be detail oriented, organized and able to multitask in fast paced environment
  • Excellent communication, interpersonal and facilitation skills
  • Ability to work collaboratively with other members of the clinical research team and other sites
  • Computer competency including proficiency in Microsoft Word, Excel and PowerPoint

Physical requirements/environmental factors:

  • Ability to lift 20-25 lbs.
  • Travel may be required.
  • Exposure to human bodily fluids.
  • Exposure to ionizing radiation
  • Occasional night and weekend work schedules.

Position Specifics

  • Monday - Friday
  • Infrequent Weekend work

 

What We Offer

  • Competitive salary
  • 401k with generous matching
  • Flexible paid time off policy

 

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.