- Coordinate research and administrative procedures for the successful management of clinical trials
- Ensure SOPs are followed
- Perform diverse administrative duties pertaining to clinical research
- Manage trial operations
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Research Coordinator I
1 week ago
WakeMed Raleigh, United StatesAbout WakeMed: · Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care.For more ...
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Clinical Research Coordinator/ Research Nurse
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M3USA Raleigh, United StatesCompany Description · M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With clos ...
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Clinical Research Coordinator
1 week ago
Tulane University Staff Raleigh, United StatesThe primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials in cardiovascular and chronic kidney diseases. The Clinical Research Coordinator assists the investigator team to develop ...
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Clinical Research Coordinator/ Research Nurse
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Wake Research Raleigh, United StatesJob Description · Job DescriptionCompany Description · M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical researc ...
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Clinical Research Coordinator
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SiteBridge Research, Inc. Raleigh, United States FreelanceJob Description · Job DescriptionSiteBridge Description: · Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on b ...
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Assistant Clinical Research Coordinator
1 week ago
North Carolina State University RALEIGH, United StatesThe Coordinator will manage the schedule of the research team and the research participants, arrange the experiments through emails and phone calls, recruit participants in local clinics and hospital, conduct initial patient screening and help the re Clinical Research, Research C ...
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Assistant Clinical Research Coordinator
1 week ago
North Carolina State University Raleigh, United StatesThe UNC-NCSU Joint Department of Biomedical Engineering stresses the application of science and engineering, mathematical analysis, and computer techniques to biomedical problems. The research and entrepreneurship of the faculty, students, and staff aim to accumulate, generate an ...
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Clinical Research Coordinator
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ICON Clinical Research Cary, United StatesAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. · Our 'Own It' culture is driven by four key values that bring us together as individuals ...
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Mycobacteriology Laboratory Supervisor
4 days ago
North Carolina Dept of Health and Human Services Wake County, NC, United States**Description of Work**: · - This is a Medical Laboratory Supervisor I position that will provide direct laboratory supervision, planning and coordination, for all testing services performed by the NCSLPH Microbiology Unit's Mycobacteriology Laboratory section. This position supe ...
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Business Analyst- Senior
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Novalink Solutions LLC Raleigh, United StatesNC Department of Health and Human Services seeks a Senior Business Analyst/Technical Writer to support IT software development projects implemented by vendors and/or in-house development teams. · Primary tasks include: · • Identify and document stakeholders, data flows, and curre ...
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Executive Assistant
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CYB Human Resources Raleigh, United StatesClassification · Non-exempt · Reports to · CEO · Summary/Objective · The Executive Assistant will work closely with the CEO and assist with day-to-day management including scheduling, communication, task prioritization, and travel arrangements. The position will require a high l ...
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Clinical Research Coordinator
1 week ago
M3 Global Research Durham, United StatesCompany Description · M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With clos ...
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Clinical Research Coordinator
3 weeks ago
University of North Carolina at Chapel Hill Chapel Hill, United StatesA global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the art ...
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Clinical Research Coordinator
3 weeks ago
Duke University Durham, United StatesSchool of Medicine · Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clini ...
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Clinical Research Coordinator
3 weeks ago
Duke University Durham, United StatesOccupational Summary · The Department of Pediatrics is looking to hire an experienced Clinical Research Coordinator to our Pediatric Cardiology research group. Prior experience working in Pediatric populations, and working in complex clinical trials is preferred, but not required ...
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Clinical Research Coordinator
3 weeks ago
Duke University Durham, United StatesSchool of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinici ...
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Clinical Research Coordinator
1 week ago
M3USA Durham, United StatesCompany Description · M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With clos ...
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Clinical Research Coordinator
3 weeks ago
Duke University Durham, United StatesSchool of Medicine · Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clini ...
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Clinical Research Coordinator
3 weeks ago
University of North Carolina at Chapel Hill Chapel Hill, United StatesA global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the art ...
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Clinical Research Coordinator
1 week ago
Duke University Durham, United StatesSchool of Medicine · Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clini ...
Clinical Research Coordinator - Raleigh, NC, United States - US Foot & Ankle Specialists
Description
The CRC is responsible for managing and conducting clinical research projects by leading overall trial operations, collecting data, informing study participants about study objectives, administering questionnaires, ensuring Foot and Ankle Specialists of the Mid-Atlantic (FASMA) Standard Operating Procedures (SOPs) are followed and working closely with the sponsor/Clinical Research Organization (CRO).
Job Purpose:
Duties/Responsibilities:
Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory, institutional policies, and FASMA SOPs.
Has an in-depth knowledge of protocol requirements.Acts as liaison between the investigators, medical providers, the Institutional Review Board (IRB), CRO and sponsor.
Maintains required records of study activity including Case Report Forms (CRFs), source, narrative notes, drug dispensing records, and all regulatory forms.
Tracks enrollment status of subjects and documents withdrawal information such as withdrawal causes and subject contact efforts.Inputs and uploads subject information and pertinent clinical data to study specific study databases and/or EDC (Electronic Data Capture) sites and FASMA Clinical Trial Management System (CTMS) within appropriate timeframe defined by the protocol, sponsor, and SOPs.
Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians, nurses, medical assistants, and other staff.
Enters potential subject demographics into FASMA CTMS.Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
Records and reports serious adverse events to the sponsor or other regulatory authorities within the appropriate reporting guidelines and timeframe.
Prepares, participates, and documents quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.Identifies protocol problems, informs investigators of problems, and assists in problem resolution efforts such as protocol revisions.
Manages the inventory of equipment and supplies related to each study. This includes ordering of Investigational Product (IP), temperature recording devices, calibrations, and all necessary supplies for study completion.
Prepares study-related documentation such as protocol worksheets, source, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Maintains complete regulatory files and Investigator Site File (ISF).This includes completing all appropriate subject logs, screening and enrollment logs, study product/IP accountability logs, training documents, filing all applicable documents, correspondence etc.
Completes and submits IRB initial, renewal and closure applications.Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, and documentation procedures.
Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings.May assist with contracting with local vendors such as local laboratory.
Reviews scientific literature and participates in relevant education activities to maintain knowledge of clinical studies affairs and issues.
Maintains Good Clinical Practice (GCP) certification and all other project specific certifications.
Maintains accurate and legible records, following ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles
Manages site specific research staff CV's, licenses and applicable trainings (i.e. GCP, IATA, etc.)
Ensures site has all appropriate credentials and certifications (i.e. IATA, CLIA, etc.). If applicable, with approval, assist with renewal or apply for appropriate credentials and certifications.
Acts as a contact liaison for study participants by answering questions and keeping them informed of study protocol.
Communicates with manager with all pertinent study related progress, issues and when subjects have completed the trial.
Arranges for secure retention of all study documents in accordance with sponsor requirements and site SOP, whichever is longer.
Manage all locked areas where investigational or study products and supplies are stored.Tracks and maintains temperature and maintenance logs and/or devices for research related equipment.
Draws blood or supervises the on-site drawing of blood as dictated by the research protocol. For delegated blood draws, document fully on the Delegation of Authority log. Coordinates local lab draws as needed. For post markets studies, this will usually only involve a finger stick. Acquires other lab requirements as necessary per protocol.
Manages the day-to-day activities of each study including trial operations, problem solving, communication, inventory control, and protocol management.
Maintain strict confidentiality and blinding protocol, if applicable, at all times.
Responds to study queries within appropriate timeframe defined by the protocol, sponsor, and SOPs.
Required Skills/Abilities:
Excellent attention to detail
Knowledge of biological and medical terminology
Understanding of the principles of administration and management
Superior organizational and time management
Capable of working independently and also as part of a team
Excellent verbal and written communication skills
Superior multi-tasking skills
Education and
Experience:
Education:
Preferable to have an Associate's degree in business administration, biology, health sciences, healthcare or any related field, or comparable clinical research industry experience.
Experience:
Preferable to have a minimum of 2 years of Site Coordinating experience. Must have exceptional technical and communication skills. Candidate needs the ability to be proactive, multitask and maintain excellent organizational skills.
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Working in a fast-paced clinic setting assisting with patient visits and patient care
Must be able to lift up to 15 pounds at times.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)