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Exception Template
Ref No.: 18-14538
Location: New York, New York
Job Title: Clinical Research Coordinator
Location: New York, NY
Duration: 3+ Months of Contract

Job Details:

Under supervision, the clinical research coordinator will assist in carrying out research activities related to clinical research and laboratory/translational research. In addition, they will be given the opportunity to enhance their research skills by working with our diverse team of researchers.

• In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
• Obtains informed consent according to GCP.
• Schedules subject visits.
• Prepares labs/tests per protocol.
• Monitors and evaluates patients' condition with regard to the investigational product.
• Conducts routine assessments to evaluate the subject's response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate.
• Meets with the study monitor to review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of study records.
• Reports subject's progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner.
• Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed.
• Notifies appropriate management and external parties of serious adverse events according to protocol.
• Maintains the study file record according to GCP.
• Maintains subject participant records according to GCP.
• Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
• Other duties as assigned.
• The position requires 20 – 25% travel between assigned facilities and various locations within the community.
• Half year position with possibility to extend

• Bachelor's Degree in Sciences or Technology required. Master's degree is desired.

• 0 to 2 years' healthcare experience with Dialysis experience preferred.
• Clinical research experience and training preferred.
• Familiar with GCP and IRB regulations rules.
• Ability to work independently.