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Clinical Trials Research Coordinator

In California / United States

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Clinical Trials Research Coordinator   

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JOB TITLE:
Clinical Trials Research Coordinator
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Oakland California / United States

JOB DESCRIPTION :

Responsibilities:

  • Study Implementation Maintain the security and confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol and/or IRB-approved telephone script, collect and document
  • research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner.
  • Coordinate and schedule participants for study assessments/visits, required tests, including visit specific lab kits and/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). With appropriate guidance, obtain and review medical records and test results of all project/study participants and abstract needed data per protocol requirements.
  • With guidance from PI, complete case report forms (paper or electronic) and maintain a database program to track all study activity including study enrollment and
  • Respond to Sponsor to resolve data queries and delinquencies in a timely manner.
  • Report any potential protocol violations/deviations to the PI in a timely manner. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).
  • Coordinate and prepare protocol specimens for shipping or storage in accordance with IATA/DOT regulations and Sponsor shipping guidelines.
  • Assist with participant's long-term follow-up data collection. Assist PI and/or Clinical Trial Nurse, if applicable, with identifying, screening, and recruiting potential participants. Provide PI and/or Clinical Trial
  • Nurse with the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.
  • With guidance, receive, disseminate and maintain study-related communications
  • with internal and external parties involved with clinical trial protocols. Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates.
  • Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial. With direction, maintain the site(s) study regulatory binder(s) and ensure that other study-specific documentation is maintained. Assist the Clinical Trial Nurse with quality assurance, training, abstracting and recording data. Coordinate space requirements for study-related equipment/supplies.

Position Details

S16174661671923720
California / United States
Oakland
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Clinical Trials Research Coordinator    Apply

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Responsibilities:

  • Study Implementation Maintain the security and confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol and/or IRB-approved telephone script, collect and document
  • research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner.
  • Coordinate and schedule participants for study assessments/visits, required tests, including visit specific lab kits and/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). With appropriate guidance, obtain and review medical records and test results of all project/study participants and abstract needed data per protocol requirements.
  • With guidance from PI, complete case report forms (paper or electronic) and maintain a database program to track all study activity including study enrollment and
  • Respond to Sponsor to resolve data queries and delinquencies in a timely manner.
  • Report any potential protocol violations/deviations to the PI in a timely manner. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).
  • Coordinate and prepare protocol specimens for shipping or storage in accordance with IATA/DOT regulations and Sponsor shipping guidelines.
  • Assist with participant's long-term follow-up data collection. Assist PI and/or Clinical Trial Nurse, if applicable, with identifying, screening, and recruiting potential participants. Provide PI and/or Clinical Trial
  • Nurse with the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.
  • With guidance, receive, disseminate and maintain study-related communications
  • with internal and external parties involved with clinical trial protocols. Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates.
  • Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial. With direction, maintain the site(s) study regulatory binder(s) and ensure that other study-specific documentation is maintained. Assist the Clinical Trial Nurse with quality assurance, training, abstracting and recording data. Coordinate space requirements for study-related equipment/supplies.