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Clinical Research Coordinator

Center for Pharmaceutical Research

Clinical Research Coordinator

Kansas City, MO
Full Time
Paid
  • Responsibilities

    Alliance for Multispecialty Research is a fast growing clinical research organization that conduct trials for the development of pharmaceuticals.

    AMR offers competitive pay, 401K matching, health/dental/vision, paid STD and LTD, as well as on demand access to your pay!

    Team Member Benefits:

    · Health, Dental, Vision

    · Supplemental Life Coverage

    · Short-term Disability and Long-term Disability (AMR covers cost)

    · Life Insurance (AMR covers cost of AD&D $50,000)

    · 401K (employer matching)

    · Paid Time Off

    · Holiday Pay

    · Employee Assistance Program

    Clinical Research of South Florida is looking for an experience Coordinator to join our growing team. CRSF conducts phase II-IV research in a wide range of indications in Coral Gables, FL.

    General Description

    The primary responsibility of the Clinical Research Coordinator is to manage all clinical aspects of assigned clinical trials. The Clinical Research Coordinator is required to have an in-depth knowledge of the protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the Clinical Research Coordinator may act as liaison between the investigator and the sponsor. Along with the investigator, and the assistance of our recruiting team, the Clinical Research Coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the Clinical Research Coordinator is responsible for all data and source documentation and adverse experience documentation and reporting.

    Qualifications

    Registered nurse, licensed practical nurse, or other licensed medical professional (foreign accepted) with at least 2 years clinical experience or ancillary medical training with at least 5 years of clinical experience.

    Bilingual (English Spanish) is required.

    Specific responsibilities include but are not limited to the following:

    Possess a sound and in depth understating of each protocol that has been assigned as a primary responsibility.

    Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol.

    Review the protocol summary sheet and the informed consent form for accuracy and clarity.

    Develop draft protocol source documents and then review the worksheets for accuracy and clarity or review the source documents as prepared by selected staff for accuracy and clarity.

    Develop a mechanism for subject recruitment with the recruiting staff and ongoing culminations with primary care physicians and nursing staff, as appropriate.

    Enrollment and follow-up of study subjects

    Screening and enrollment procedures

    Review and verify all relevant source documentation in the subject record to confirm study eligibility.

    Review the protocol, informed consent form, and follow-up procedure with potential study subjects.

    Ensure the current approved informed consent form is signed before subjects are screened and enrolled.

    Ensure the randomization procedure is followed as per protocol guidelines.

    Document protocol exemptions and deviations as appropriate.

    Subject follow-up procedures

    Ensure adherence to protocol visits.

    Schedule subjects for follow-up visits.

    Assess subject response to therapy and evaluate for AEs.

    Review lab data and communicate abnormal values to PI.

    Assess and document subject compliance with medications and visits. Communicate with pharmacy staff as needed to assure timely and accurate study drug distribution.

    Administer study drug therapy as needed (as legally appropriate).

    Maintain copies of all prescriptions written for study drug supplies as appropriate.

    Ensure appropriate specimen collections.

    Attend study-related meetings as appropriate.

    Communicate regularly with PI about study related issues.

    Study documentation

    Maintain source documentation for all CRF entries, including clinical chart visit notes, lab data, and procedure reports.

    Ensure data is available to data entry personnel in a timely manner.

    Assure queries or data clarification forms are routed to data entry personnel in a timely manner.

    Adverse experience monitoring and reporting responsibilities

    Assess and record all AES as outline in the protocol.

    Report all serious AEs to the PI, sponsor’s monitor, and IRB as outlined in the protocol or other source (e.g. IRB requirements).

    Communicate SAEs to data entry personnel to ensure entry into the CRF within protocol required timelines.

    Regulatory documentation

    Forward regulatory documents to Regulatory and maintain copies of all relevant regulatory documents.

    Act as backup to regulatory for all assigned studies.

    Sponsor and/or FDA audits

    Ensure that all required documentation is complete and appropriately filed.

    Provide all required documentation to auditors.

    Make all appropriate corrections as requested by auditors.

    Management of ancillary staff

    Train and supervise support staff (e.g., research assistants and/or clerical staff).

    Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.