Research Coordinator Position Available In Clay, Florida

Research Coordinator 3.7 3.7 out of 5 stars 705 Wells Road, Orange Park, FL 32073 Coastal Health is currently searching for a Research Coordinator to join our growing team. The Clinical Research Coordinator is responsible for overall trial performance and conduct for assigned trials congruent to the philosophy and mission of Coastal Clinical Research Specialists, promote good clinical practices in the conduct of clinical trials by possessing an in depth knowledge of federal, state and local regulations and Coastal Clinical Research Specialists SOPs for the enrollment, maintenance and safety of subjects in assigned trials. Perform a variety of subject care and administrative duties to support activities that meet objectives of assigned research protocol(s). Collect, record and maintain all Coastal Clinical Research Specialists and Sponsor required documentation.

Responsibilities:

Demonstrate thorough knowledge of and strict adherence to assigned protocol(s) Attend Investigator and/or other meetings as required and orient staff to assigned protocols Provide subject care and data collection procedures in adherence with the assigned study protocol(s) and in accordance with good clinical practices Ensure that IRB approval of protocol and informed consent form is obtained prior to initiation of trial Have a thorough knowledge of Informed Consent process as required by company SOPs and regulatory agencies Obtain written consent for subject participation in a study prior to initiating any protocol procedures. Obtain timely re-consent when required. Assess for ability to provide consent or assent as needed Collect initial medical history by interviewing subjects and/or caregivers and obtaining medical records as necessary. Ongoing collection and appropriate documentation of pertinent information throughout trial Communicate relevant information to subjects physician(s) if requested after obtaining written permission to do so Educate patients and family regarding their study and clinical trial participation in general. Explain diagnostic procedures and method of treatment to address subject and family concerns Maintain accurate records of receipt, inventory, and dispensation of study drug and trial materials Perform clinical tasks, including, but not limited to, obtaining vital signs, height and weight, ECG, phlebotomy, and specimen packaging and storage per protocol directions Obtain subject samples, blood, cultures, tissues, and other specimens for laboratory analysis as described in the study protocol. Maintain current IATA certification Complete source documents and Case Report Forms (CRFs) or eCRFs in accordance with Sponsor requirements and Coastal Clinical Research Specialists SOPs Inspect source documentation, CRFs/eCRFs and study files to ensure completeness and accuracy Complete monitor and Sponsor queries in a timely manner as required per Sponsor Ensure documentation of communication and relevant contacts between patient, study staff, sponsor, CRO, monitors and any marketing or third party vendor hired by Sponsor or CRO Obtain required training and/or certification and demonstrate proficiency in administering protocol-required rating scales, maintain inter-rater reliability with other Coastal Clinical Research Specialists through discussion and review of rating scales. Complete all required rater training for assigned trials in a timely manner Review source documentation, CRFs/eCRFs and study files with Sponsor or Sponsors designee at all monitoring visits. Make necessary corrections to CRFs/eCRFs in a timely manner Comply with federal, state and local regulations, Sponsor guidance, Institutional Review Board (IRB) requirements and Coastal Clinical Research Specialists SOPs Bachelors degree in health, science or research-related field Two years experience in research or healthcare environment Detail-oriented individual with the ability to collect, document and analyze information Demonstrate professional communication (written and verbal) Demonstrate ability to establish rapport and maintain professional interaction skills Ability to communicate research protocol requirements effectively to potential trial participants and team members Ability to work independently, manage time effectively, prioritize tasks and work efficiently Bachelors degree in health, science or research-related field Two years experience in research or healthcare environment Detail-oriented individual with the ability to collect, document and analyze information Demonstrate professional communication (written and verbal) Demonstrate ability to establish rapport and maintain professional interaction skills Ability to communicate research protocol requirements effectively to potential trial participants and team members Ability to work independently, manage time effectively, prioritize tasks and work efficiently