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Clinical Research Coordinator

Company: Evolution Research Group
Location: Rochester
Posted on: January 15, 2021

Job Description:

Company Summary:ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 12 wholly owned clinical sites and 12 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 240+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.The ERG portfolio consists of St. Louis Clinical Trials, Woodland International Research Group, Woodland Research Northwest, Midwest Clinical Research, Pacific Research Network, Clinical Pharmacology of Miami, Brain Matters Research, Neuropsychiatric Research Center and Endeavor Clinical Trials, all supported by an industry leading centralized infrastructure located in New Jersey.Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible. We accomplish this with employees who are passionate about clinical research, focused on patient care and respect and use excellence as their yardstick in everything they do each day.Position Purpose/Summary:Responsible for the overall coordination, organization, and efficient implementation of clinical trials. Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator. Maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies.Essential Job FunctionsGeneral* Obtains detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator prior to the effective date of the study.* Reviews with Principal Investigator and/or Medical Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.* Works with the sponsor and Principal Investigator to ensure compliance with protocol requirements.* Work with Principal Investigator, Site Director and Recruitment Specialist to develop effective programs for study enrollmentStudy Management* Perform study activities under the direction and delegation of the Principal Investigator* Attends the investigator meeting for each assigned protocol, as appropriate.* In conjunction with Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.* Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator* Review informed consent from with potential study volunteers* Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations* Maintain organized, accurate and complete study records* Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.* Enter data as appropriate for protocol (paper-electronic data capture)* In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol* Perform study close-out procedures* Store study records appropriatelyKnowledge, Education, and Experience* Registered Nurse, Required.* Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.* Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.* Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.* Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.* Minimum of 1 year clinical research experience preferred.* Experience with IV infusions, injections and phlebotomy preferred.Skills and Abilities* Excellent communication skills (interpersonal, written, verbal)* Ability to perform overnight business travel* Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Real Time)

Keywords: Evolution Research Group, Rochester , Clinical Research Coordinator, Other , Rochester, New York

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