Clinical Data Specialist jobs in Cambridge, MA

Responsible for operational aspects of planning and management of site performance in accordance with departmental expectations. May act as primary liaison between in-house CRAs, field based CRAs and the Clinical Project Manager (CPM). Supports and assists Clinical Project Managers in operationalizing multiple clinical research studies.

• Supports preparation and may develop materials related to the training and presentations for Investigator Meetings.
• Facilitates CRA project meetings.
• Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends

• Track and report on progress of the study including site activation, patient enrollment and monitoring visits.
• Ensures that all sites are provided supplies in accordance with study start-up expectations.
• Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with the CPM.
• Develop PSV/SIV/IMV and other training tools and training materials in support of the project.
• Assist in the review of CRO and other third party vendors invoices to ensure that work is performed in accordance with

• Ensure that monitoring visits are performed in accordance with the protocol, monitoring plan, and applicable SOPs.
• Responsible for the development of any mass site communication as appropriate.
• Responsible for operationalizing clinical protocols at the site level and ensuring appropriate SOPs are being followed for

• Participate in eCRF in User Acceptance Testing (UAT) and the creation of eCRF completion guidelines and ensuring site

• Work with CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol

• Contact sites as needed for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled

• Assist with study start-up activities including development of the first draft of the ICF.
• Assist with the review of protocol, protocol amendments, ICF and CSR documents as required.
• Provide active mentorship of CTA staff to build talent across the department.
• Agenda distribution & minute taking for internal study team meetings.
• Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.
• Experience working in clinical research within a pharmaceutical company or CRO or similar organization.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Ability to work successfully within a cross-functional team.
• Strong knowledge of applicable computer and project management software packages.
• Excellent written and oral communication skills.
• Ability to interact with investigators, vendors, and internal colleagues.
• Knowledge of current regulatory requirements and guidelines governing clinical research.
• Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner.