Outstanding Biotech company seeks candidate to provide support to the Clinical Department by assisting with execution and maintenance of clinical studies. This position is responsible for maintaining, updating and establishing various databases for clinical tracking. In addition, this position is responsible for ordering and shipping supplies in coordination with all phases of the clinical studies, maintaining files and inventories of chemicals, supplies and equipment.
Responsibilities and Duties:
•Acts as study and/or in-house site lead for multiple projects simultaneously with an understanding of clinical study management /prioritization.
•Performs clinical data entry and validation to ensure accuracy, completeness and legibility of data.
•Assists users with requests for clinical documents.
•Assists with the development and evaluation of clinical record forms; maintains internal record keeping system of clinical records, including master files for clinical protocol.
•Maintains and audits data, providing status and activity reports as required.
•Conducts qualification, site initiation, interim, and closeout monitoring visits.
•Works on multiple projects and routinely creates, suggests, and/or implements regular process improvements.
•Provides training to study staff and subjects at clinical sites.
•Collaborates effectively with peers and leadership across departments and can professionally communicate with FDA, IRB, and key opinion leaders.
-Bachelor’s degree in biological sciences or combination of related education and applicable work experience may be considered.
-Professional certification in one or both of the following: CCRA, CCRP.
-4 to 6 years’ experience in a clinical setting with expertise in the following:
-Experience as a study coordinator for in-house studies required
-Experience with handling supply demand of clinical studies
-Experience with writing professional correspondence, clinical documents and reports
-Experience managing multiple, diversified tasks concurrently with ability to prioritize projects and tasks effectively.
-Experience with clinical trials a plus
-Experience in the therapeutic area of oncology useful
-Basic understanding of FDA Good Clinical Practice (GCP) guidelines in the conduct of clinical studies
-Knowledge of medical terminology
-Ability to communicate clearly in person, on the phone, and in writing and establish /maintain cooperative relationships with staff and others.
-Demonstrated proficiency in computer skills such as word processing, and Excel.
-High attention to detail and accuracy
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