Clinical Research Coordinator (CRC)/San Antonio, TX

Cutting Edge Research Center has exciting opportunity in the world of research!

POSITION:   Clinical Research Coordinator

 

SUPERVISOR:    Administrator

 

DESCRIPTION:    Coordinates all clinical trials

  to include solicitation of new studies; patient follow-up;

Staff education and coordination, and accurate documentation.

   

 

REQUIREMENTS:    Certified, Medical Assistant, LVN, RN or equivalent experience.

 

At least FIVE (5) years of medical office experience and/or TWO (2) years of Research experience.

 

    Intermediate computer skills and excellent medical terminology

 

Must be analytical, creative, detail oriented and organized with the ability to work independently.

   

Must be Certified Clinical Research Coordinator or willing to become ACRP – certified within 2 years of hire date. Must keep certification status current by complying with CME requirement(s).

 

Must achieve a rating scale of 2 or more on all activities listed on the Orientation check list within 90 days of hire.

 

Must attend investigator meetings as needed per protocol.

 

Must attend weekly Research meetings for ongoing training on SOP’s GCP and regulatory information.

 

 

RESPONSIBILITIES:

 

  Position

 

Obtain detailed knowledge of all components of study protocol through independent analysis and review of study to complete all study activities 

correctly and completely.

 

    Obtain and maintain documentation for each study to satisfy Institutional

Review Board (IRB) and Federal Drug Administration (FDA) requirements.

 

    Work with pharmaceutical and research companies on details of studies,

    maintaining and completion of case report forms.

 

    Screen volunteer patients to identify potential patients for a specific study

    accurately, on a timely basis and within the recruitment period.

 

 

    Schedule all patient visits and procedures to meet the protocol requirements.

    Provide instructions and date to patients to ensure proper protocol compliance.

 

    Makes all source documents for new studies

 

Ensures patient training per protocol on diary completion, study drug

    administration,etc.

 

    Ensure that all research staff performs all protocol activities

(including the Investigator) and the patient to meet protocol requirements.

 

    Validate potential patient data against pre-established inclusion criteria to

enroll qualified patients only. 

 

 

Ensure that all laboratory samples are collected properly and tests are

    performed at the designated lab facility accurately and on a timely basis.

    Prepares the lab paperwork for all studies and prepares the lab work for

shipping in an accurate manner. Maintains contact with the central lab for 

    the results of all lab testing. Must prepare lab kits one day prior to patient

visit.

 

    Distributes the study medication according to the protocol requirements

    and maintain accurate and complete distribution records. Will maintain the

experimental drug supplies with documentation of receipt, dispensing and the

return of unused drugs at completion of the study.

 

    Notifies the patient and physician of all adverse reactions to study

    medications and identifies what is a “serious adverse reaction” versus

non-emergent and sponsor requirements.

 

Reports all adverse events to the sponsor and IRB in compliance with FDA

    regulations and sponsor requirements. 

 

Reports all serious adverse events within 24 hours to the sponsor and the IRB.

 

Solicitation of new studies for the CRC.

 

    Attends Clinical Trials Investigators meetings for new studies  that may

require overnight travel.

 

    Work with other staff members on study requirements in accordance with the

    protocol.

 

Must represent the Clinical Research Center in a professional manner

    including adhering to a dress code.

 

    Other duties as assigned by the Director, CRC

 



Documentation

Provide the sponsor with accurate and complete documentation and

    information during each site visit.

 

    Complete and maintain accurate, legible and complete source documents and

case report forms per FDA guidelines. Retain and/or forward copies of forms

as required by the sponsor.

 

 

Patient Care

 

Be a patient advocate and ensure the safety and welfare of all patients.

 

    Explain to the patient in layman’s terms, the purpose and possible benefits of

participating in a study to provide complete and accurate study information.

 

Act as a liaison between the study patient and their physician concerning any

    problems, adverse reactions, etc. related to the study medication or study

    procedures. 

 

 

    Ensure that the patient has signed the consent form before becoming

    involved in any aspects of the study as a patient and give a copy to the

    patient.

 

    Effectively report patient behavior and adverse reactions in a timely manner.

 



  Communication

 

    Interact with the physicians, ancillary services, nursing  personnel to identify

    appropriate patients promptly.

 

Act as a liaison to ensure complete and accurate communication between

physicians, sponsors and patients.

 

Work in a collaborative, effective manner with the entire research group as

    well as with the sponsor personnel to meet research objectives completely

and accurately.

 

    Follow directions provided by the investigating physician and act

accordingly.

 

    Seek clarification of established policy prior to taking action that might

deviate from standards set by federal regulations and the sponsor’s protocol.

 

Competency in working with multiple clinical trial protocols and display of

    effective interpersonal skills in working with peers on the same protocols.

 

  Please reply to :  jason.russell@soliant.com