- Obtain 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.
- Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
- Review 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.
- Manage studies with direct oversight from Site Director, and Principal Investigator to ensure compliance with protocol requirements.
- Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
- Contribute to the SOP review and development as delegated by the Site Director.
- Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
- Attend the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.
- 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 volunteer
- 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 appropriately
- Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.
- 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)
-
Clinical Research Coordinator
2 weeks ago
Evolution Research Group Rogers, United StatesJob Details · Job Location · LOC024 WRN Woodland Research North West LLC - Rogers, AR · CRC · Title: Clinical Research Coordinator · Location: Rogers, AR · About us: · ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clin ...
-
Clinical Research Coordinator
3 weeks ago
Evolution Research Group Rogers, United StatesJob DetailsJob LocationLOC024 WRN Woodland Research North West LLC - Rogers, ARCRCTitle: Clinical Research CoordinatorLocation: Rogers, ARAbout us:ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development service ...
-
Sales Inside Sales Representative
3 days ago
Nexus Innovations Rogers, AR, United States Freelance**Job Opportunities**: · ITB - that's us, a motivated, dedicated, and diverse team of 75 interdisciplinary experts. Since 1996, we have been developing and implementing standard software for product data management - with high quality standards and a lot of passion for what we do ...
-
Production Support Compliance
3 days ago
Skyline Solutions Lowell, AR, United States FreelanceOur long-standing client company in 88400 Biberach-Riss is currently looking for a **Production Support Compliance - (m/w/d)** for a temporary period of 2 years. · Monthly salary: 3,700 euros to 5,100 euros · - Our client is a pharmaceutical company founded in 1885 and is the lar ...
-
Logistics Engineer
3 weeks ago
Aurora Ventures Benton Ridge, United StatesAbout INP Deutschland GmbH: · We are a privately owned engineering company based in Römerberg. From our home in the Palatinate region, we have successfully managed projects all over the world for over 30 years. Our clients include industry leaders in international power plant and ...
-
Data Entry Coordinator
3 weeks ago
EVOLUTION RESEARCH GROUP Rogers, United StatesJob Details · Job Location · LOC024 WRN Woodland Research North West LLC - Rogers, AR · Data Entry Coordinator · Title: Data Entry Coordinator · Location: Rogers, AR · About us: · ERG is a leading U.S. based, privately held, independent clinical research site company, and provid ...
-
Laboratory Technician
1 week ago
EVOLUTION RESEARCH GROUP Rogers, United StatesJob Details · Job Location · LOC024 WRN Woodland Research North West LLC - Rogers, AR · Salary Range · $ $22.00 Hourly · Lab Tech (PRN) · Title: Lab Technician · Location: Rogers, AR · About us: · ERG is a leading U.S. based, privately held, independent clinical research site co ...
-
Laboratory Technician
3 weeks ago
EVOLUTION RESEARCH GROUP Rogers, United StatesJob Details · Job Location · LOC024 WRN Woodland Research North West LLC - Rogers, AR · Salary Range · $ $25.00 Hourly · Description · Title: Lab Technician · Location: Choose an item. · About us: · ERG is a leading U.S. based, privately held, independent clinical research site ...
-
Principal Investigator Clinical Trials
1 week ago
EVOLUTION RESEARCH GROUP Rogers, United StatesJob Details · Job Location · LOC024 WRN Woodland Research North West LLC - Rogers, AR · PI-FT · Title: Principal Investigator, NP or PA (Psych experience) · Location: Rogers, AR · About us: · ERG is a leading U.S. based, privately held, independent clinical research site company, ...
-
School Psychologist
1 week ago
LISA Academy Rogers, United StatesPosition Type: · Student Support Services/Psychologist · Date Posted: · 5/2/2024 · Location: · LISA Academy Rogers-BentonvilleJob Goal: · To assess the psycho-educational needs of students referred for special education services and to provide support to school sites including in ...
-
Theater Teacher
1 week ago
Arkansas Arts Academy Rogers, United StatesREPORTS TO: High School Principal · PRIMARY FUNCTION: Under the direct supervision of the Principal, the Theater Teacher will provide instruction in the basic techniques of Theater Education; prepare students for immediate entry into the Drama/Theater Industry or to continue stud ...
-
Theater Teacher
1 week ago
Arkansas Department of Education Rogers, United StatesREPORTS TO: High School Principal · PRIMARY FUNCTION: Under the direct supervision of the Principal, the Theater Teacher will provide instruction in the basic techniques of Theater Education; prepare students for immediate entry into the Drama/Theater Industry or to continue stud ...
-
Business Coordinator
2 weeks ago
Traverse Group, Inc. Rogers, United StatesBusiness Coordinator Position Summary · Business Coordinator supports the Sales Leader and collaborates both internally and externally with resources to achieve their team objectives. We expect this person to take ownership of team tasks and oversee them to completion on time. Ad ...
-
Associate Manager
2 weeks ago
Transplace Rogers, United StatesAbout the Role · The Associate Manager of Accounts Receivable is responsible for providing leadership and supervision of the Billing and Credit Specialist team members in their invoicing and credit management responsibilities. The position interacts regularly with both external ...
-
Director of Life Enrichment
3 weeks ago
The Aspenwood Company - Village on the Park Rogers Rogers, United StatesThe Aspenwood Company is currently recruiting for Director of Life Enrichment for at our Village on the Park Rogers location an Independent Living, Assisted Living with Memory Care senior community. · The Director is responsible for planning, scheduling and implementing activiti ...
-
Marketing Coordinator
3 weeks ago
SupplyPike Rogers, United StatesMarketing Coordinator · Department: Marketing · Employment Type: Full Time · Location: Rogers, Arkansas · Reporting To: Sydnee Fowler · Description · As a pivotal member of our dynamic team, you'll forge strong partnerships with our product and design teams to fuel SupplyPik ...
-
Product Manager
2 weeks ago
RITTER COMMUNICATIONS HOLDINGS, LLC Rogers, United StatesJob Description · Job DescriptionRitter Communications has been at the forefront of the local communications industry for more than a century. We began providing telephone service in Northeast Arkansas in 1906. Today, Ritter Communications serves over 100 communities across Arkan ...
-
Senior Job Captain
2 weeks ago
CESO Rogers, United StatesAre you a Job Captain seeking purpose, challenge, and talented colleagues? With a diverse portfolio of retail, hospitality, light industrial, healthcare, and worship, CESO has the opportunity for you to expand your career. We develop leaders and empower our associates to use thei ...
-
Bilingual Recruiter
3 weeks ago
1st Employment Staffing Rogers, United States1st Employment is now seeking someone to join our Rogers team as a Bilingual Staffing Specialist · Direct Hire-Full Time · Job Purpose: Fills manufacturing positions by determining hiring requirements; planning and implementing recruiting campaigns; targeting, contacting, and qua ...
-
Job Captain
2 weeks ago
CESO Rogers, United StatesJob Description · Are you a Job Captain seeking purpose, challenge, and talented colleagues? With a diverse portfolio of retail, hospitality, light industrial, healthcare, and worship, CESO has the opportunity for you to expand your career. We develop leaders and empower our ass ...
Clinical Research Coordinator - Rogers, United States - Evolution Research Group
Description
Job DetailsJob Location
LOC024 WRN Woodland Research North West LLC - Rogers, AR
Clinical Research Coordinator (CRC)
Title: Clinical Research Coordinator
Location: WRN
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 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
