Research Study Activation Coordinator

About the position The Research Study Activation Coordinator is responsible for facilitating the activation of clinical research studies within a healthcare research network setting. This role ensures that all administrative, regulatory, and operational tasks are completed efficiently to initiate clinical trials in compliance with institutional policies, sponsor requirements, and regulatory standards. The coordinator serves as a liaison between site network, study sponsors, investigators, and internal teams, ensuring seamless study start-up processes Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.

Responsibilities

• Management and Oversight of Study Start-up Activities for Multi-Research Site Network Effectively manage all tasks related to study feasibility, site readiness, and initiation of clinical trials.
• Coordinate timely and accurate submission of study-related documents with site and regulatory colleagues.
• Maintain strict adherence to Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines during study activation.
• Act as the central point of contact for sponsors, investigators, and internal teams, ensuring effective communication and collaboration throughout the activation process.
• Provide clear, timely updates on the status of study activation activities to all stakeholders.
• Provide Contract and Budget Coordination Facilitate contract negotiations and budget finalizations in collaboration with legal and financial teams.
• Monitor budget approvals and milestone tracking to ensure alignment with project objectives.
• Facilitate and Implement Process Improvement Identify and implement opportunities for improving study activation workflows and reducing inefficiencies.
• Maintain accurate and comprehensive documentation of all activities in compliance with institutional policies and regulatory requirements.
• Deliver training sessions to research staff on protocol requirements, regulatory standards, and activation processes.
• Support team members in developing expertise in clinical trial activation tasks.

Requirements

• High school education required
• Bachelor’s degree in life sciences, healthcare, or a related field
• Minimum 2-3 years of experience in clinical research or a related field
• Strong knowledge of clinical trial processes, IRB requirements, and regulatory guidelines
• Excellent organizational and multitasking skills with a high level of attention to detail.
• Effective communication and interpersonal skills to collaborate with diverse stakeholders.
• Proficiency in research management systems and Microsoft Office Suite.
• Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills.
• Must be detailed oriented with the ability to exercise independent judgment.
• Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness.
• Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
• Good command of the English language.
• Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
• Strong customer focus.
• Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
• Effectively manages own time, conflicting priorities, self, stress, and professional development.
• Self-motivated and self-starter with ability work independently with limited supervision.
• Ability to work remotely effectively as required.
• Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
• Proficiency in MS Office Word, Excel, Power Point, and Outlook required.

Nice-to-haves

• Certification in clinical research (e.g., CCRP, CCRC, or equivalent) preferred
• Second language is an asset but not required
• Prior experience with electronic medical records (EMR) is preferred
• Prior experience with clinical trial data entry systems (EDC) preferred
• Prior Clinical Trial Management Systems (CTMS) preferred.

Benefits

• comprehensive health insurance with a robust provider network
• 401k, which offers a 100% match and investment options
• generous Paid Time Off (PTO) program
• professional development programs
• tuition assistance

Apply tot his job Apply To this Job