Summary:

Clinical Research Coordinator has an advanced-level working knowledge of clinical research activities and has the skills to independently coordinate, direct and follow through in the overall administration and outcome of multiple clinical studies.

Responsibilities:

• Understand thoroughly all assigned studies through reading protocols, attending protocol training, attending Investigator Meetings and start-up meetings, and coordinating with the Research Manager and Principal Investigator.
• Comply with performing research activities in line with GCP/ICH guidelines. Will maintain updated certifications in GCP/ICH, IATA and protocol specific training.
• Will be responsible for conducting clinical trials in clinic as well as in surrounding dialysis clinics, with mandatory travel to and from the dialysis units.
• Adhere strictly to the study protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and other requirements.
• Assess eligibility of potential patients and oversee patient enrollment to ensure that informed consent is properly obtained and documented. Educate patients and their family members regarding the clinical trials process and the details of the specific study they are participating in.
• Coordinate and conduct patient visits, which can include drawing blood, collecting vital signs, performing ECG's, processing specimens, coordinating PI assessments, patient questionnaires, investigational product accountability.
• Keeps all source documentation up-to-date and enters data obtained from study visits into the study specific EDC systems adhering to strict timelines for data entry and query resolution. Communicate any issues with the Sponsor, CRO, PI and Research Manager in a timely manner.
• Completes study documentation and maintains study files in accordance with sponsor requirements and CNA/FMC policies and procedures including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational material accountability forms.
• Maintains effective and professional communication with the Sponsor, research participants, dialysis staff, PI and Research Manager during the course of the study.

Qualifications:

• Must have at least 2+ years of experience as a Clinical Research Coordinator.
• Must have experience with phlebotomy, collecting vital signs and performing ECG's.
• Knowledge of medical terminology.
• SoCRA or ACRP Certification would be preferred.
• One year in a healthcare setting would be preferred.
• Exceptional organizational skills and attention to detail.
• Able to demonstrate competence in oral and written communication

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• How many years of phlebotomy experience do you have?

Experience:

• Clinical Research: 2 years (Required)

Work Location: In person

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