Assisting Clinical Project Managers (CPMs) with study start-up activities, including but not limited to study-specific form development, regulatory binder/investigator package set and ship up, communications and correspondence, regulatory document submissions, equipment or supply procurement or shipping.Assisting CPMs with internal and external meeting coordination and generating meeting agenda and minutes.Managing workflow for confidentiality disclosure agreement (CDA) review, submission, and execution, study form reviews by client, regulatory document receipt/review, and eTMF document upload, maintenance, and review.Acting as subject matter expert (SME) for the eTMF system, including serving as a business administrator, master list updates, validation management, and training for other ProSciento colleagues.Contributing to the periodic review of the study files for accuracy and completeness.Assisting with upkeep of the clinical trial management system (CTMS) site database and with export of applicable study data for eTMF set up.Assisting CPMs with the selection of investigators, as well as with site issue resolution.Working with investigative sites and ad-hoc team members to complete all documentation necessary.Determining completeness and readiness to support clinical supplies/investigational product shipment.Aiding in laboratory sample reconciliation and sample management as needed.Assisting in preparing submissions for independent ethics committees (IECs) or institutional review boards (IRBs) by compiling the package of documents for IEC/IRB and forwarding to either the investigator or IEC/IRB as directed.Supporting the CPM with third-party vendor oversight activities.Assisting with electronic data capture (EDC) query resolution activities, particularly with sites external to ProSciento.Assisting clinical teams in evaluating the investigator’s performance at closeout to facilitate future site identification activities.

Overseeing the electronic Trial Master File (eTMF) and ensuring its accurate and up-to-date representation of all essential clinical trial documents.Supporting eTMF review process by working closely with study teams.Preparing the eTMF for study and site activation.Performing QC of both internal and external documents, including essential documents and IRB applications.Opening, closing, and tracking eTMF file reviews for the study teams.Assisting study teams in tracking of essential study documents and periodic review to assure accuracy and completeness.Supporting eTMF closeout activities including reporting, exporting and data archiving.Assisting in preparing study-related documentation, such as investigator meeting materials, feasibility questionnaires, and study-specific training materials.Maintaining the Clinical Trial Management System (CTMS) to ensure accurate tracking and reporting of study progress and data.Updating CTMS with study-related information, including site activation status, monitoring visits, study deliverables, and study milestones.Uploading study deliverables and assigning training materials for study team members.Providing study teams with eTMF metrics, protocol-specific training reports, and CTMS updates.

Training and transitioning studies to new members in the department.Overseeing the statuses of projects assigned to colleagues.Reviewing and committing digital forms and managing sample tracking/forecasting per study contract and OSD specifications.Working with the courier to troubleshoot shipping issues.Performing form reviews/queries as well as monitoring, editing, and quality controlling forms as necessary.Managing site/lab digital pen usage and compliance.Escalating digital pen issues to appropriate group.Serving as the secondary and/or tertiary project contact with sponsors and contract research organizations to ensure appropriate communication channels are maintained.Performing QC of requested protocol-related documents before they are released to clientMaintaining internal and client-facing databases.Coordinating with sites, labs, and other departments to resolve queries.Troubleshooting edit checks, sample discrepancies, and digital pen issues.Managing site lists, patient trackers, and other protocol-specific records.Adapting to Laboratory Information Management System (LIMS) updates and new procedures.

Reviewing and committing digital forms and managing sample tracking/forecasting per study contract and OSD specifications.Working with the courier to troubleshoot shipping issues.Performing form reviews/queries as well as monitoring, editing, and quality controlling forms as necessary.Managing site/lab digital pen usage and compliance.Escalating digital pen issues to appropriate group.Serving as the secondary and/or tertiary project contact with sponsors and contract research organizations to ensure appropriate communication channels are maintained.Performing QC of requested protocol-related documents before they are released to clientMaintaining internal and client-facing databases.Coordinating with sites, labs, and other departments to resolve queries.Troubleshooting edit checks, sample discrepancies, and digital pen issues.Managing site lists, patient trackers, and other protocol-specific records.Adapting to Laboratory Information Management System (LIMS) updates and new procedures.

Conducting comprehensive literature reviews to gather relevant information on current public health issues.Developing a plan for statistical analysis of local survey data sets and national public databases.Writing SAS code to import, clean, and manage the datasets.Performing data analysis and reporting on descriptive statistics, regression models, and non-parametric tests.Reviewing SAS log to identify syntax errors and potential revisions to the code.Producing SAS output in the form of descriptive tables and statistical test results.Interpreting the results in the context of the research objectives .Summarizing results of the analysis and emphasizing any trends and patterns.Collaborating with the research advisor to draw meaningful conclusions and implications from the data.Preparing a manuscript for submission to an academic journal.Presenting and interpreting the results in terms of public health research.