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Clinical Research Coord I
3 months ago
ABOUT USEach 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 SUMMARYResponsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and company guidelines, regulations, and policies.DUTIES AND RESPONSIBILITIES DESCRIPTIONCoordinating 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.)o 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 criteriao Coordinating scheduled visits and adhering to protocol visit windows and timelineso Perform or follow up on safety and efficacy assessments per protocol •vital signs, EKGs, blood draws and other assessments as assignedo Collaborating with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimeno Accurate and timely completion of source documents recording subject's participation in studyo Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelineso Assist investigators in collection of information from study subjects regarding AEs, concomitant medications and other changes throughout participationo Responsible for subject scheduling, in coordination with Recruitingo Responsible for timely data entry and query resolutiono Timely reporting of study events (SAEs, protocol deviations, etc) to appropriate departments and other outside agencies (Sponsors, CRO's, etc.)o Following subjects through study completion and creating follow-up care plan with physician, study subject and primary care provider;Ensuring preparation for and facilitating of all study monitoring visits and following up promptly with monitor follow-up lettersPrompt and professional communication with sponsors, representatives and other study related partiesMaintaining professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff membersKeeping management informed of study status and any study-related issuesAssumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.EDUCATION/EXPERIENCE/SKILLSBachelor's Degree or equivalent experience in Clinical Research or related field.Demonstrated expertise in:o knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trialso providing strong leadership and mentorship to otherso developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor levelo crisis management and problem solving; ability to react calmly and effectively in emergent situationso working independently as well as functioning as part of a teamo communicating clearly both written and verballyHighly proficient in:o In the use of technology required for the completion of study visits and study conducto completing paperwork with precision, accuracy, and attention to detailo meeting timelines and attention to detailo prioritizing daily tasks with minimal guidanceo using medical equipment and instruments to administer study subject careo medical terminologyMust be able to effectively communicate verbally and in writing.WORKING CONDITIONSIndoor, 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.
