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Clinical Research Coordinator

Company: Evolution Research Group
Location: San Antonio
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/SummaryThe Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. This position completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. The role also maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided FDA regulations, Good Clinical Practice (GCP), 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 and Site Director prior to the effective date of the study.* Reviews with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.* Manages studies with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.* Manages studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.* Serves as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.* Contribute to the SOP review and development as delegated by the Site Director.Study Management* Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.* Attends the investigator meeting for each assigned protocol, as appropriate.* In conjunction with Site Director and 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 and obtain 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 appropriatelyQualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.The ideal candidate will have:* 1 year of clinical research experience is preferred* High School Diploma or its equivalent; College degree preferred.* Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.* Knowledgeable in medical terminologyKnowledge, 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 Study Manager)Work Environment: This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Keywords: Evolution Research Group, San Antonio , Clinical Research Coordinator, Other , San Antonio, Texas

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