Clinical Data Specialist

Job DescriptionThis position will play a critical role in ensuring the ethical and responsible conduct of clinical trials to protect study participants from potential harm, safeguard the integrity of the trial. By identifying potential problems early, the clinical data specialist can help prevent serious adverse events and ensure that the trial results are reliable and informative. Perform responsibilities meeting project commitments and in compliance with applicable regulations, good clinical practice (GCP) and standards. ResponsibilitiesFocus on the safety of participants by reviewing adverse events, monitoring for potential harm, and assessing the overall benefit-risk ratio of the trial.

Review accumulating data, assessing risks and benefits, and make recommendations to the sponsor regarding the trial's continuation, modification, or termination. Assist with data cleaning leading into finalizing study reportsMonitor the progress of the trial, including enrollment rates, participant retention, and the overall pace of the study. Assess whether the trial is being conducted according to the approved protocol and identify any deviations or potential issues. Periodically monitor study data integrity and safety data to ensure consistency among study sites and across studies. Responsible for implementing and maintaining the effectiveness of the quality system.

Conducts assigned clinical operations activities in accordance with applicable regulations; GCP, policies and procedures. Support internal audit and other compliance-related activities (e. g. preparation for audits, QA verification of clinical data, OEC review of Scientific Research and Publications, tracking of supplies for Sunshine Act reporting). Provide clinical study support to CRA's (e. g. prepare study master file binder, route clinical records, complete study-related exception reports). Supports clinical research team with review and monitoring of clinical study data. Identify the need for new processes and technologies to support an increase in quality, productivity and efficiency.

Identify and participate in process improvement initiatives. May participate in a lead role for a project. Participate in training and educational opportunities for personal development and cross-training within the organization. Support current and new processes and procedures for the Clinical Research organization in accordance with applicable regulations; GCP; and ADD policies and procedures. This may include. Development and maintenance of Clinical Research procedures, templates and forms. Requirements: B. S. in Biological Science or Medical Specialty preferred. Minimum 6 years' experience in a clinical research environment or a research laboratory with automated IVD assay/instrument experience, including data analysis.

Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required. Experience with contracts and knowledge of electronic document management systems (e. g. APLM, SBM and other databases) desired.