Evolution Research Group
Clinical Research Coordinator (CRC)-FT
Evolution Research Group, Dayton, Ohio, United States, 45444
Job Details
Job LocationLOC017 MCRC Midwest Clinical Research Center - Dayton, OH
CRC-FT
Title: Clinical Research Coordinator (CRC)-FT
Location: Dayton, OH
About us:
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, 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.
Job Description:
The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC 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. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
Responsibilities:
General
Obtain detailed knowledge of each study protocol by reviewing it with the Principal Investigator and Site Director before the study starts.Assist in drafting and reviewing source documents for accuracy before study launch.Clarify any study components with the Principal Investigator and Site Director as needed before initiation.Oversee studies under the Site Director and Principal Investigator to ensure protocol compliance.Collaborate with the Principal Investigator, Site Director, and Recruitment Manager to support study enrollment.Contribute to SOP review and development as directed by the Site Director.Study Management
Conduct study activities as assigned by the Principal Investigator under the Site Director's supervision.Attend investigator meetings as directed, ensure protocol adherence, and report any breaches to sponsors, IRBs, or regulatory bodies.Screen, enroll, and schedule subjects; review and obtain informed consent.Document communications with sponsors, labs, IRBs, and maintain accurate study records.Support data integrity and subject safety, enter protocol-required data, and report adverse events.Perform study close-out procedures.Additional responsibilities may be assigned as needed, with the description adaptable to ERG's objectives.Skills and Qualifications:
Education and experience
High School Diploma or its equivalent; College degree preferred.Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.Knowledgeable in medical terminology to communicate with physician office and laboratory staff.Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Requirements
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.Excellent communication skills (interpersonal, written, verbal)Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
Job LocationLOC017 MCRC Midwest Clinical Research Center - Dayton, OH
CRC-FT
Title: Clinical Research Coordinator (CRC)-FT
Location: Dayton, OH
About us:
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, 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.
Job Description:
The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC 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. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
Responsibilities:
General
Obtain detailed knowledge of each study protocol by reviewing it with the Principal Investigator and Site Director before the study starts.Assist in drafting and reviewing source documents for accuracy before study launch.Clarify any study components with the Principal Investigator and Site Director as needed before initiation.Oversee studies under the Site Director and Principal Investigator to ensure protocol compliance.Collaborate with the Principal Investigator, Site Director, and Recruitment Manager to support study enrollment.Contribute to SOP review and development as directed by the Site Director.Study Management
Conduct study activities as assigned by the Principal Investigator under the Site Director's supervision.Attend investigator meetings as directed, ensure protocol adherence, and report any breaches to sponsors, IRBs, or regulatory bodies.Screen, enroll, and schedule subjects; review and obtain informed consent.Document communications with sponsors, labs, IRBs, and maintain accurate study records.Support data integrity and subject safety, enter protocol-required data, and report adverse events.Perform study close-out procedures.Additional responsibilities may be assigned as needed, with the description adaptable to ERG's objectives.Skills and Qualifications:
Education and experience
High School Diploma or its equivalent; College degree preferred.Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.Knowledgeable in medical terminology to communicate with physician office and laboratory staff.Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Requirements
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.Excellent communication skills (interpersonal, written, verbal)Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)