Senior Clinical Monitoring Associate
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POST DATE 9/2/2016
END DATE 10/14/2016
JOB DESCRIPTIONAPPLY Bellicum Pharmaceuticals is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.
As we grow and transform we continue to welcome very talented scientists, technicians, CRA s and others who are well experienced in the world of cellular immunology and biologics.
Currently we are recruiting a Senior Clinical Monitoring Associate who will be responsible for the monitoring of Bellicum clinical trials, adhering to Good Clinical Practices, investigator integrity and compliance with all study procedures ensuring they are completed in accordance with the project.
Assures compliance with CFR, State regulations, ICH and GCP guidelines and
Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
Participates in TMF and on-site audits as requested.
Assumes responsibility for site management and site staff performance including:
Monitors various types of clinical trials.
Participates in all types of site visits.
Assures Principal Investigator (PI) integrity.
Assures compliance with all protocol requirements.
Assures effective patient identification and recruitment plan is in place.
Assures timely reporting of AEs/ SAEs and Protocol Violations.
Regularly performs Investigational Product (IP) accountability.
Regularly reviews the status of contents of the site Regulatory Binder.
Performs source document verification (SDV) according to contractual requirements.
Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
Assures timely and accurate completion of Data Clarification Forms (DCFs).
Performs clinical data listings reviews as needed.
REPORTING AND TRACKING
Completes and submits trip reports according to SOP requirements.
Maintains awareness of key study performance indicators for own sites, e.g. patient enrollment, SAEs.
Updates study and patient status information and serves as resource for LCRA/AD.
Tracks Investigator payments/ milestones, if requested.
Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
Attends investigator s meetings as requested. May assist with preparation.
Assists with the preparation of study start up materials and tools, as requested.
Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.