Research Manager

Responsibilities

• Manage and coordinate clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines.
• Oversee workflows, processes, clinical study coordinators, and data support teams for patient-facing aspects of clinical trials across multiple therapeutic areas, including oncology and Phase I oncology.
• Collaborate with business development teams and Study Intake Program Managers to ensure research projects are high quality, operationally feasible, and aligned with investigator and patient needs.
• Meet clinical trial accrual metrics and execution timelines by working closely with Core Managers and facility leaders.
• Provide daily management, annual evaluations, coaching, and mentorship to clinical study coordinators and data teams to support long-term team sustainability.
• Develop and implement approaches to monitor and evaluate the quality of clinical operations, ensuring continuous improvement.
• Work with regulatory specialists to implement steps necessary to maintain compliance with external regulatory agencies and internal policies.
• Manage the delivery of safe, patient-centered care with respect for the dignity and rights of all research participants.
• Plan, organize, and manage all activities related to clinical research operations, ensuring effective and compliant study coordination across multiple therapeutic areas.
• Collaborate with Research Services, Study Intake, Portfolio Management, and clinical study coordinators to develop study budgets for all research projects within supported therapeutic areas.
• Partner with the Senior Clinical Operations Manager and Core Managers to design and implement processes that optimize workflow and scheduling for clinical operations.
• Collaborate with peer Clinical Operations Managers to resource and staff all projects within the portfolio, including studies outside of primary therapeutic areas.
• Provide leadership for research participant recruitment, data entry, and data management, ensuring optimal recruitment strategies and standardization across research teams.
• Perform managerial duties related to the selection, onboarding, supervision, development, and appraisal of research staff.
• Collaborate with other research departments to ensure compliance with federal, state, local, and institutional regulations and policies.
• Absorb and implement established Standard Operating Procedures (SOPs) for clinical operations, research training, and staff certification.
• Assess situational needs and stakeholder input to make informed staffing and resourcing decisions that drive optimal research participant enrollment and timely trial completion.
• Ensure that clinical operations adhere to best practices in clinical research, including documentation, data quality, and participant safety.

Essential Skills

• 10+ years of experience as a lead research coordinator or research manager with increasing people management responsibilities.
• 5+ years of experience as a research nurse/registered nurse or non-nurse coordinator in a healthcare setting or research site.
• 5+ years of experience in a healthcare or research setting with demonstrated experience managing teams.
• Proven ability to manage and coordinate clinical trials in compliance with FDA regulations and ICH/GCP guidelines.
• Demonstrated experience in clinical operations and clinical research, including oncology and Phase I oncology.
• Strong project management skills, including planning, organizing, and executing clinical research timelines.
• Experience overseeing clinical study coordinators and data support teams in a patient-facing research environment.
• Ability to collaborate effectively with cross-functional teams, including business development, Study Intake, Portfolio Management, and regulatory specialists.
• Demonstrated capability to develop, monitor, and improve clinical operations workflows and processes.
• Strong leadership skills in staffing, resourcing, scheduling, and performance management of clinical research teams.
• Proficiency in ensuring regulatory compliance and working with offices such as Sponsored Programs, Research Integrity, and IRBs.
• Excellent communication, stakeholder management, and problem-solving skills.
• Bachelor’s degree in Healthcare Administration, Business, or a related field.

Additional Skills & Qualifications

• Master’s degree in Healthcare Administration, Business, or a related field is preferred.
• 7+ years of experience as a research nurse/registered nurse or non-nurse coordinator in a healthcare setting or research site is preferred.
• Demonstrated experience staffing, resourcing, and scheduling clinical study coordinator and data teams to support a diverse portfolio of research studies is preferred.
• Experience leading research operations across multiple therapeutic areas, including oncology and Phase I oncology.
• Registered Nurse (RN) license is preferred.
• Basic Life Support (BLS) – CPR certification is preferred.
• Certified Clinical Research Coordinator (CCRC) certification is preferred.
• Membership or certification through the Association of Clinical Research Professionals (ACRP) is preferred.
• Membership or certification through the Society of Clinical Research Associates (SOCRA) is preferred.
• Experience establishing and maintaining Standard Operating Procedures (SOPs) for clinical operations and research training.
• Ability to interpret and apply federal, state, local, and institutional regulations to clinical research operations.
• Strong organizational skills and attention to detail in managing complex clinical trial portfolios.