Study Start Up:
- Participate in evaluation of new clinical research protocol requests to assess feasibility of proposed study resource allocation and clinical needs.
- Serve as the primary resource to investigators, sponsors, clinical research staff and collaborators for clinical research conduct of complex and multi-center studies.
- Collaborate on planning, designing, and reviewing study specific budget and documentation needs, coordinator effort and hospital resources; establishing priorities and recommending schedules, timetables and costs.
- Oversee division clinical research submission process for new studies, facilitating research determination, interdisciplinary reviews and status tracking of the department study portfolios in regulatory review.
- Assist compliance team with IRB submissions, amendments, and regulatory documents.
Clinical Trial Coordination:
- Assists with protocol and budget review of potential sponsored projects related to departmental initiatives.
- Serve as liaison to sponsor/CRO for study start up and regulatory needs.
- Maintain master file for ongoing departmental clinical research activities to ensure progress with subject enrollments, data and reporting requirements.
- Coordinate patient screening, recruitment, consent, visit scheduling, patient monitoring and follow per protocol guidelines.
- Collect and process specimens to meet study requirements per protocol.
- Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
- Participate in local and national collaborative calls related to program operations.
- Ensure quality and timely submission of data across studies.
- Provide project reports and other documentation throughout the project lifecycle.
- Proactively take initiative to ensure enrollment stays on track with the project timelines.
Oversight and Reporting:
- Maintenance and reporting of departmental study portfolios by PI and divisions.
- Provide day to day operational oversight of the departmental research activities.
- Oversight of study specific team tasks including accurate screening, enrollment processes, data collection and reporting.
- Identify and coordinate multidisciplinary team(s) to support coordinator needs and address challenges for study implementation in a timely manner.
- Determine coordinator placement on upcoming studies, facilitate completion of trainings, ensure compliance with regulatory requirements and billing processes.
- Ongoing assessment of team workload, expectations, and goals through regular review of data integrity and study performance and troubleshooting as needed.
- Provide guidance to research personnel and support staff; coach and mentor study team to build knowledge and skills; create learning opportunities for employees.
Collaborations and Communications:
- Serve as liaison between Division Chiefs, COM-P clinical research administration, hospital and community partners and mentors.
- Regular review of regulatory compliance and metrics reporting and alignment of departmental research efforts to those of the College.
- Periodic review and recommendations to update COM-P specific study related charges to ensure adequate coverage of ongoing resource costs.
- Ensure completion of investigator trainings, compliance reporting and evaluation.
- Timely identification of obstacles and potential solutions for successful success.
- Effective collaboration to ensure progress in enrollment milestones and study completion.
- Assist other members by educating, providing resources and consulting on difficult protocols or projects.
Knowledge, Skills & Abilities:
- Skilled in troubleshooting and critical thinking to resolve issues in clinical research settings.
- Able to multitask and prioritize in high-pressure environments.
- Self-motivated with a strong ability to work independently.
- Flexible schedule to support patient enrollment and follow-up in critical care studies.
- Ability to handle complex or high-risk patient interactions with empathy and professionalism.
- Skilled in Leadership and Team Collaboration: Ability to train, mentor, and supervise junior coordinators and research assistants.
- Strong communication skills for collaborating with physicians, study sponsors, and other stakeholders.
- Time Management and Organizational Skills.
Read Full Description