East Coast Institute for Research

Provide operational oversight for clinical research services including site acquisition, quality improvement, staff education, and executive communication. | Bachelor's degree, 3+ years clinical research operations experience at site network level, strong communication, organizational, leadership, and technical skills. | CLINICAL RESEARCH PROJECT MANAGER Position Summary: The Clinical Research Project Manager provides operational oversight for clinical research services including site acquisition and integration, continuous quality improvement, staff education on change management, and reporting to guide data-based decision-making. Duties/Responsibilities: • Collaboratively develops and implements strategic plans for clinical research operations. • Analyzes operational data to evaluate performance, reveal trends, identify opportunities, and leverage technology to improve organizational performance. • Serves as point of contact for clinical research operations, communicating with executive leadership to keep projects aligned with wider goals and employee satisfaction. • Manages integration of new sites into the Rovia network, developing and implementing strategies for smooth transitions, talent retention, business function consolidation, and internal communications. • Provides general executive support to the COO and operations business unit as directed. • May perform other job-related duties as requested. Required Skills/Abilities: • Excellent verbal and written communication skills. • Strong organizational skills. • Proficient in the use of Microsoft Office. • Excellent leadership, team building, collaboration, and communication skills. • Demonstrated knowledge of clinical research quality improvement and change management. • Strong technical skills and familiarity with clinical research systems including EHRs and CTMS. Education and Experience: • Bachelor's degree required. • 3+ years of experience in clinical research operations, specifically at the site network level.

Conduct feasibility assessments for clinical trial sites by analyzing data, site capacity, patient demographics, and regulatory requirements to support study planning. | Bachelor’s degree in life sciences or related field with at least 1 year experience in site feasibility or study start-up and strong knowledge of clinical trial methodology and regulatory guidelines. | FEASIBILITY SPECIALIST Position Summary: The Feasibility Specialist will play a crucial role in assessing the viability of clinical trials across our network of sites, performing critical tasks such as conducting comprehensive feasibility assessments, evaluating study protocols, and collaborating with internal teams to ensure the successful execution of clinical trials. Duties/Responsibilities: • Gathers and analyzes historical data, site metrics, and patient demographics to provide evidence-based recommendations on site selection and feasibility. • Identifies and screens potential clinical research sites based on study-specific criteria including patient demographics, geographic location, and investigator expertise. • Collaborates with site staff to assess their capacity, capability, and resources to conduct the proposed trial. • Conducts detailed feasibility assessments to evaluate site capacity for patient recruitment, adherence to protocol, and data quality standards. • Analyzes the availability of target patient populations with each site’s catchment area to ensure adequate recruitment potential, estimating recruitment timelines and identifying strategies to mitigate recruitment challenges. • Provides analysis for site-specific cost considerations and budget development, including staffing, equipment, and other resources. • Assesses local regulatory requirements and their impact on site feasibility and study timelines. • Works closely with internal study teams, investigators, and sponsors to communicate feasibility findings and address any site-specific concerns. • Prepares comprehensive feasibility reports and presents feasibility results to internal stakeholders, providing actionable insights to support study planning. • May perform other job-related duties as requested or required. Required Skills/Abilities: • Excellent interpersonal and communication skills. • Strong understanding of clinical trial methodology and regulatory guidelines required. • Sound knowledge of medical terminology. • Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices. Education and Experience: • Bachelor’s degree required, preferably in life sciences, health care, or a related field. • At least 1 year of experience in site feasibility or study start-up at a clinical research multi-site organization. • Strong understanding of clinical trial methodology required.