- 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)
-
Research Coordinator
1 week ago
Colliers Dallas, United StatesMake your next move an expert one. · At Colliers it's not our success that sets us apart, it's how we achieve it. Our people are passionate, take ownership and always do what's right for our clients, people and communities. · Why Colliers? · Our enterprising environment needs ...
-
Clinical Research Coordinator
2 weeks ago
Medix™ Irving, United StatesPosition Overview: · As a Clinical Research Coordinator, you will play a key role in the planning, implementation, and coordination of clinical research studies. Working closely with investigators, healthcare professionals, and study participants, you will ensure the successful e ...
-
Psychometrician/Research Coordinator
1 week ago
Res-Care, Inc. Irving, United StatesOur Company · Pate Rehabilitation · Overview · Pate Rehabilitation has an immediate opening for a PART TIME dual role position involving psychometrician and research coordinator duties to join our team · This is a part time position with potential to move to a Full-Time position. ...
-
Psychometrician/Research Coordinator
2 weeks ago
BrightSpring Health Services Irving, United States· Psychometrician/Research Coordinator · Job Locations · US-TX-IRVING · ID · Line of Business · Pate Rehabilitation · Position Type · Part-Time · Our Company · Pate Rehabilitation · Overview · Pate Rehabilitation has an immediate opening for a PART TIME dual role position invol ...
-
Clinical Research Coordinator
6 days ago
Children's Health Plano, United StatesClinical Research Coordinator - Oncology (Plano Study Coordinator) · * Our Plano campus is looking for an experienced Clinical Research Coordinator who will play an important part in coordinating drug treatment research trials within the Hematology and Oncology teams, as well as ...
-
Nebula Ventures Carrollton, United StatesYOUR RESPONSIBILITIES · You have a passion for fashion and lifestyle - so do we In our purchasing department, we shape and accompany the fashion of tomorrow from the very beginning and decide what will be sold in our NEW YORKER stores worldwide. Join us and become part of our tea ...
-
Clinical Research Coordinator
2 weeks ago
Baylor Scott & White Health Dallas, United States Full timeShift: 8AM-5PM · Department: Patient and Community Engaged Research · Location: 3434 Live Oak Street, Dallas, 75204 · JOB SUMMARY · The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials durin ...
-
Clinical Research Coordinator
1 week ago
Dallas VA Research Corporation Dallas, United StatesEducation and Experience Requirements: · Must be eligible to work in the U.S.; H1b visa holders are ineligible · More than 4 years of research experience; or · 3+ years of research experience and a Bachelor Degree in a relevant area; or · 3+ years of research experience and a ...
-
Clinical Research Coordinator
1 week ago
Baylor Scott & White Health Dallas, United StatesShift 8AM-5PM · Location: 3409 Worth St, Dallas, 7524 · JOB SUMMARY · The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation throug ...
-
Clinical Research Coordinator
1 week ago
EmVenio Research Dallas, United StatesABOUT EMVENIO RESEARCH: · EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing b ...
-
Research Data Coordinator
2 weeks ago
Baylor Scott & White Health Dallas, United States Full timeShift: 8AM -5PM · Location: · 3500 Gaston Ave, Dallas, 75246 · JOB SUMMARY · The Research Data Coordinator locates, procures and integrates data from a variety of research and clinical sources; prepares and uploads data to public repositories; develops and troubleshoots study-sp ...
-
Clinical Research Coordinator
1 week ago
ALLERGY PARTNERS Dallas, United StatesJob Details · Job Location · 70-00-Dallas - Dallas, TX · Description · JOB SUMMARY: clinical coordination of all aspects of adult and/or pediatric clinical research trials primarily sponsored by pharmaceutical companies. · Responsibilities include, but are not limited to, the fo ...
-
Clinical Research Coordinator
4 days ago
DALLAS VA RESEARCH CORPORATION Dallas, United StatesJob Description · Job DescriptionEducation and Experience Requirements: · Must be eligible to work in the U.S.; H1b visa holders are ineligible · More than 4 years of research experience; or · 3+ years of research experience and a Bachelor Degree in a relevant area; or · 3+ y ...
-
Clinical Research Coordinator
2 weeks ago
Baylor Scott & White Health Dallas, United States Full timeShift 8AM-5PM · Location: 3409 Worth St, Dallas, 7524 · JOB SUMMARY · The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation throug ...
-
Clinical Research Coordinator
2 weeks ago
Search Influence Dallas, United StatesABOUT EMVENIO RESEARCH: · EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing b ...
-
Clinical Research Coordinator
2 weeks ago
EmVenio Research Dallas, United StatesJob Description · Job Description · ABOUT EMVENIO RESEARCH: · EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that ...
-
Clinical Research Coordinator
2 weeks ago
Baylor Scott & White Health Dallas, United States**Shift** : 8AM-5PM · **Department** : Patient and Community Engaged Research · **Location** : 3434 Live Oak Street, Dallas, 75204 · **JOB SUMMARY** · The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clin ...
-
Clinical Research Coordinator
6 days ago
EmVenio Research Dallas, United StatesJob Description · Job DescriptionABOUT EMVENIO RESEARCH: · EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that bene ...
-
Clinical Research Coordinator
1 week ago
Baylor Scott & White Health Dallas, United States**Shift** : 8AM-5PM**Department** : Patient and Community Engaged Research**Location** : 3434 Live Oak Street, Dallas, 75204**JOB SUMMARY**The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials ...
-
Clinical Research Coordinator
6 days ago
WILLIAM R LUMRY MD PA Dallas, United StatesJob Description · Job DescriptionSeeking experienced Clinical Research Coordinator to assist with ongoing clinical trials in the asthma and allergy space. Experience witn regulatory, patient recruitment and assessment, electronic data capture and conduct of clinical trial require ...
Clinical Research Coordinator - Carrollton, United States - EVOLUTION RESEARCH GROUP
Description
Job DetailsJob Location
LOC011 HDR Legent Orthopedic Hospital - Carrollton, TX
Description
Title: Clinical Research Coordinator
Location: Carrollton, TX
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
