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Posted: Monday, February 27, 2017 12:07 PM

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About the Job


CLINICAL RESEARCH COORDINATOR


Job Description






Clinical Research Coordinators (CRCs) perform multiple and varied tasks critical to the management of clinical research studies. CRCs handle all basic clinical research study activities and conduct studies following all GCP/ICH guidelines, HIPAA requirements and Clinical Research Prime SOPs.



Reports to: Chief Research Officer and Principal Investigators



Qualifications/Job Requirements:




Experience with a Clinical Trial Management Software (CTMS) system (e.g., RealTime CTMS or Clinical Conductor)

Successful completion of formal/clinical training program(s), such as those required of registered nurses, licensed practical nurses, CNAs, emergency medical technician, R.T., and certified medical assistants or equivalent job experience, with no less than one year of clinical experience involving patient care in a healthcare environment.

Currently is or eligible to be a Certified Research Clinical Coordinator (CCRC)

Ability to perform if needed, clinical, laboratory and diagnostic tests, including phlebotomy, vitals and ECGs.

Ability to function independently without close supervision, and to consistently exercise discretion and the highest level of good clinical and other professional judgment.

Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.

Ability to effectively devote keen and acute attention to detail.

Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).

Strong written and verbal communication skills as well as strong interpersonal skills.

Strong self-motivation skills and the ability to be a “self-starter,” coupled with the capability to work as a team player, as well as independently, while simultaneously managing a variety of clinical research study related projects.

Ability to meet and satisfy flexible, dynamic work schedules and be “on-call” if necessary.

Successful completion of IATA or Mayo training concerning the handling and shipping of hazardous goods and materials, followed by recertification every two years following initial certification.

Successful completion of CITI training, followed by recertification every two years following initial certification

Ability to be ambulatory most of work day

Ability to lift / transfer / carry a minimum of 25 pounds without difficulty

Basic knowledge of Microsoft Office products (Outlook, Word, Excel)

Access to Internet at home to monitor email, access the CTMS system and the temperature monitoring system as needed





Responsibilities:

Study Coordinators shall:



Provide administrative support to the Clinical Research Manager and to Study Investigators engaged in the performance of clinical research studies. Tasks required to fulfill this responsibility include obtaining proper written informed consent from each potential study participant prior to participation in the study; reading and understanding study protocols, interpretation of clinical, laboratory and diagnostic tests; applying such interpretations to advise the Clinical Research Manager and Study Investigators concerning management of clinical research studies.

Design and maintain organizational tools to ensure that each clinical research study is conducted accurately and in compliance with good clinical practice guidelines, including the creation of necessary protocol source documents and logs.

Communicate with clinical research sponsors, CROs, monitors, laboratories and clinical personnel within the research industry to assist in the implementation of clinical research studies.

Research and apply all federal Food and Drug Administration (FDA) regulations and guidelines applicable to clinical research studies to ensure compliance with federal law, ICH/GCP guidelines and HIPAA requirements.

Coordinate and assume responsibility for initiating, maintaining and closing clinical research studies.

Coordinate and supervise direct patient/study participant care associated with various clinical research studies. Tasks required to fulfill this responsibility include, but are not limited to, reacting to and providing recommendations based on new/unanticipated adverse events; performing electrocardiograms, taking and interpreting vital signs; properly identifying, obtaining, processing and shipping, relevant laboratory specimens; receiving the results of laboratory tests associated therewith, and recording those tests.

Supervise and coordinate personnel and events associated with clinical research studies to promote compliance with study protocols and ensure the safety and welfare of all patients/study participants.

Accurate and comprehensive collection of medical data and information.

Assist Study Investigators and physicians in protocols and procedures required for the successful implementation and completion of each clinical research study, and monitor compliance with procedures and protocols.

Recruit and screen potential patient/study participants compliant with each clinical research study protocol’s inclusion and exclusion criteria. To successfully satisfy this responsibility, Study Coordinators must be wholly familiar with the protocols, procedures and criteria associated with each clinical research study and accurately interpret and apply those protocols, procedures and criteria. This responsibility also requires Study to develop an appropriate pre-screener and recruitment materials as well as obtain proper written informed consent from each potential study participant, prior to participation in the study.

Identify all adverse experiences and report such experiences and the basis for the occurrence to principal investigators and/or sub-investigators. Successful completion of this responsibility requires Study Coordinators to apply medical knowledge, data, events and occurrences to determine what may constitute adverse experiences.

Maintain accurate and complete source documents for each study participant that record and reflect all observations and data collected from those participants during clinical trials. Successful completion of this responsibility requires knowledge of the protocol requirements as to what information is relevant for inclusion in source documents.

Advise and inform Study Investigators and Chief Research Officer concerning all pertinent issues regarding studies in addition to those noted above, including AEs and SAEs.

Effectively communicate with pharmaceutical company sponsors concerning all aspects of study activities. Successful completion of this responsibility requires the Study Coordinator to meet and discuss with monitors and other representatives the progress and results of clinical research studies.

Utilize computer software applications to enhance workflow and study activity efficiency. Successful completion of this responsibility requires knowledge of the requirements of each clinical research study and exercising independent judgment to identify appropriate software applications. Responsibility also includes the accurate completion of Case Report Forms, Electronic Data Capture (EDC) and resulting queries within guidelines established by CMR.

Travel and attend meetings and activities associated with clinical research studies, including, but not limited to, professional meetings to acquire additional specialized knowledge in the area pertaining to a clinical research study.




Working Conditions:


Independent multi-specialty research center. Direct contact with patients, staff and physicians. Exposure to communicable diseases and body fluids, hazardous substances and other conditions common to clinical environment. Exposure to emergency situations.




Essential Functions:


Ability to lift, push, manipulate equipment and subjects which requires strength, gross motor and fine motor coordination. Ability to perform CPR and venipuncture. Ability to stand or sit for long periods of time.




If Interested, please send resume to:



Justin Baker, PhD, RAC

justin.baker@crprime.clinic

• Location: East Idaho

• Post ID: 6917893 eastidaho
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