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Clinical Research Coordinator I - Englewood, United States - CenExel
Description
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.
Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.
We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and company guidelines, regulations, and policies
Essential Responsibilities and Duties:
Coordinating all aspects of patient involvement from study initiation until study completion;Study start-up:o assist in the creation of thorough and accurate source documents;o Work collaboratively with other internal departments, sponsors and investigators to ensure protocols are understood and assist in the trainings of staff memberso Participate in IMs and SIVs; communicating with sponsors and representativeso Ensure site receives accurate information and supplies from sponsors (i
e:
source, protocol, scales, supplies, approvals, contacts, etc.)Screening participants for actively enrolling studieso Assist in reviewing all participant history from Pre-Enrollment and Enrollment departments confirming information with potential participant and study physiciano Educating potential participants and caregivers on protocol specific details and expectations;o Working with the physician to address all questions and concerns related to the trial and informed consent process;o Maintaining thorough knowledge of study specific inclusion/exclusion criteriaCoordinating scheduled visits and adhering to protocol visit windows and timelineso Perform or follow up on safety and efficacy assessments per protocol
Education/Experience/Skills:
At least 1 year of experience working as a Clinical Research Coordinator.
CCRC certification not required, but preferredExperience in neurology not required, but preferredKnowledge of "good clinical practices" for clinical research as defined by the Code of Federal Regulations (CFR).Demonstrate organizational skills to efficiently and effectively manage multiple clinical trials while providing accurate information in a timely manner.
Communicate and work effectively with a diverse team of professionalsPhlebotomy and ECGs experience not required, but preferredKnowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.
Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
Must be self-directed and be able to manage multiple projects and responsibilities.Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately and experience with various EDC platformsExperience with IRB portals, such as WIRB and Advarra preferredA critical thinker with strong attention to detail and superb problem-solving abilities.
Compensation:
$28-32/h.
Application window will close on April 25th, 2024.Working Conditions Indoor, office environment.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
CenExel Clinical Research is an Equal Opportunity Employer.
All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
