Clinical Research Coordinator
2 months ago
- Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and site manager
- Always maintain subject and document confidentiality, understand and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, Good Clinical Practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, Institutional Review Boards, and institutional policies and procedures
- Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment
- Create and complete study related documents and new study preparation
- Function as a liaison with pharmaceutical sponsors and external vendors
- Prepare for study monitor visits (onsite or remote), audit inspections, etc.
- Respond to internal and external requests for information in a timely manner
- Perform subject screening and recruitment
- Contribute to data management for research projects
- Identify opportunities to improve patient care and satisfaction
- Conduct patient-facing encounters with compassion, empathy, and thoroughness
- Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects
- Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose
- Obtains and documents adverse event data on appropriate forms
- Ensure source documents are transcribed to EDC platform per protocol on a timely manner
- Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team
- Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team
- Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
- Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
- Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate
- Ensure that electronic case report forms are completed
- Create memos, emails, and letters related to study activities
- Create and maintain reports and/or spreadsheets as requested
- Ensure that all patient data is entered into the clinical trial management system in a timely manner
- Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
- Responsible for reporting safety information to all regulatory agencies
- Understand the aspects of Regulatory and IRB requirements for studies
- Performs quality checks on source documents specific to the study
- Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed
- Highschool diploma or general education degree (GED) required
- Bachelor’s Degree in scientific area of study preferred; OR
- Equivalent combination of education, training, and experience, or promotion internally from Research Assistant role
- Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS
- Must have strong knowledge of ICH/GCP guidelines
- Must complete GCP training before interacting with participants and must re-certify every 3 years
- Must be certified in administration of Fibroscan (training provided during onboarding)
- Must have basic life support (BLS) certification (can obtain during onboarding)
- Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
- Strong written and oral communication skills
- Knowledge of basic medical terminology
- Possess impeccable integrity and personal and professional values that are consistent with DRI’s high standards and mission
- Comply with the company policies, code of ethics, and guiding values
- Fluency in English AND Spanish required
- Fluency in Spanish is required
- Must be able to effectively communicate with all levels of internal and external contacts
- Ability to work independently and multi-task in a fast-paced team environment
- Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment
- Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients
- Must be able to work independently and collaborate with a team
- Ability to interpret clinical research protocols
- Strong problem-solving and decision-making skills, particularly when under pressure
- Proactive at identifying, addressing, and solving issues in real time
- Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment
- Work is performed in an office/laboratory and/or a clinical environment.
- Exposure to biological fluids and/or bloodborne pathogens.
- Personal protective equipment required such as protective eyewear, garments, and gloves.
- Occasional travel may be required domestic and/or international.
- Ability to work in an upright and/or stationary position for 6-10 hours per day.
- Frequent mobility required.
- Occasionally squatting, kneeling, or bending.
- Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
Dallas Research Institute is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
About Pinnacle Clinical Research:
Pinnacle Clinical Research is dedicated to conducting cutting-edge research with a special focus on fatty liver disease (non-alcoholic). We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Be a part of the discovery
We have other current jobs related to this field that you can find below
-
Bilingual Clinical Research Coordinator
2 weeks ago
Farmers Branch, United States Medix Full timeSummary: Seeking a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study...
-
Bilingual Clinical Research Coordinator
3 weeks ago
Farmers Branch, United States Medix™ Full timeSummary: Seeking a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study...
-
Bilingual Clinical Research Coordinator
3 weeks ago
Farmers Branch, United States Medix™ Full timeSummary: Seeking a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study...
-
Senior Clinical Research Coordinator
3 weeks ago
Long Branch, United States Vitalief Full timeWHY VITALIEF? Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients'...
-
Senior Clinical Research Coordinator
3 weeks ago
Long Branch, United States Vitalief Full timeJob DescriptionJob DescriptionWHY VITALIEF?Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to...
-
Senior Clinical Research Coordinator
3 weeks ago
Long Branch, United States Vitalief Inc. Full timeWHY VITALIEF?Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’...
-
Senior Clinical Research Coordinator
3 weeks ago
Long Branch, United States Vitalief Inc. Full timeWHY VITALIEF?Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’...
-
Grants Coordinator
3 weeks ago
Farmers Branch, United States City of Farmers Branch Full timePerforms a variety of technical and administrative tasks in support of assigned grants and special projects; analyzes conducts, and coordinates assigned special projects; and acts as project manager on various grant programs. Professional work includes but is not limited to preparing, monitoring, and coordinating the financial and administrative operations...
-
Marketing and Sales Assistant
3 weeks ago
Farmers Branch, United States Pursuit Enterprise Full timeJob DescriptionJob DescriptionWell-established Marketing and Sales Firm in Addison invites you to join our team as a Marketing and Sales Assistant. We partner with some of the nation's largest telecommunication and wireless providers to supply wireless solutions to underserved communities. This astonishing opportunity offers a great culture and growth...
-
intelligence operations specialist
4 weeks ago
Farmers Branch, Texas, United States Defense Counterintelligence And Security Agency Full timeAs a INTELLIGENCE OPERATIONS SPECIALIST you will be responsible for the following duties:Apply a full range of targeting methodologies, tools, and approaches to gain a comprehensive understanding of complex analytic issues and incorporate insights and finding into well-crafted, sophisticated intelligence products. Plan and coordinate the preparation of...
-
Clinical Director
1 month ago
Flowery Branch, United States Kiel Laboratories, Inc. Full timeOverview:Kiel Laboratories is a pharmaceutical research and development company located in Flowery Branch, GA. Kiel’s core competencies include CMC Research and Development, Quality Assurance, Regulatory Affairs, Clinical Development, Business Development, and Outsourcing. As a pharmaceutical research and development firm, Kiel has been responsible for...
-
Clinical Director
2 months ago
Flowery Branch, United States Kiel Laboratories, Inc. Full timeOverview:Kiel Laboratories is a pharmaceutical research and development company located in Flowery Branch, GA. Kiel’s core competencies include CMC Research and Development, Quality Assurance, Regulatory Affairs, Clinical Development, Business Development, and Outsourcing. As a pharmaceutical research and development firm, Kiel has been responsible for...
-
Marketer/Community Liaison
4 weeks ago
Farmers Branch, United States Amatus Health Care Full timeJob DescriptionJob DescriptionAre you passionate about making a difference in people's lives? Do you thrive in a dynamic, fast-paced environment where every day presents new challenges and opportunities for growth? If so, we have the perfect opportunity for you! The Marketing/Community Liaison is responsible for articulating and promoting the...
-
Affirmative Action Business Consultant
2 months ago
Farmers Branch, United States LTG Full timeMain Purpose: The Affirmative Action Business Consultant consults with clients regarding EEO, affirmative action, and/or diversity strategy. Prepares and delivers presentations and training to colleagues, clients, attorneys, and government representatives on EEO, Affirmative Action or diversity. Assures the proper use of current or requested programming,...
-
Registered Nurse
2 months ago
Farmers Branch, United States Oak Street Health Inc Full timeRegistered NurseCompany: Oak Street Health Title: Center Nurse Role Description The purpose of a Center Nurse at Oak Street Health is to build strong relationships with Oak Street Health patients by coordinating their care and providing a seamless experience to patients and their support team. At Oak Street Health you will use an integrated approach...
-
General Aide
2 months ago
Farmers Branch, United States Texans Can Charter Schools Full timePrimary Purpose: Under the supervision of an Assistant Principal, provides administrative support that integrates related, yet unique sub-functions and teams Performs complex secretarial and administrative support duties, including but not limited to reception, transcription of documents, administrative support to projects and programs, maintenance of...
-
Senior Document Specialist
4 weeks ago
Farmers Branch, United States Fay Servicing Full timeFounded in early 2008, Fay Servicing is committed to providing innovative servicing solutions for both performing and non-performing mortgage loans. As a specialty mortgage servicer and originator who sees the customer behind every loan, we understand that our customers aren’t loan numbers — they’re homeowners. Before founding our company, we conducted...
-
Affirmative Action Business Consultant
2 months ago
Farmers Branch, United States Learning Technologies Group Full timeMain Purpose: The Affirmative Action Business Consultant consults with clients regarding EEO, affirmative action, and/or diversity strategy. Prepares and delivers presentations and training to colleagues, clients, attorneys, and government representatives on EEO, Affirmative Action or diversity. Assures the proper use of current or requested...
-
Clinical Instructor-Med Surg
1 month ago
Long Branch, United States Monmouth Medical Center Full timeRWJBarnabas Health is seeking a highly dedicated Medical /Surgical Clinical Instructor for the Develop Innovation & Research Department, at Monmouth Medical Center.Monmouth Medical Center (MMC) is one of New Jersey's largest community teaching hospitals, where physicians and employees work as a team dedicated to academic and clinical excellence and...
-
Medical Assistant
1 week ago
Farmers Branch, United States UnitedHealth Group Full time$1,500 Sign-on Bonus for External Candidates Opportunities at WellMed, part of the Optum family of businesses. We believe all patients are entitled to the highest level of medical care. Here, you will join a team who shares your passion for helping people achieve better health. With opportunities for physicians, clinical staff and non-patient-facing roles,...