Under the Direction of Dr. Daniel Corcos, the Clinical Research Manager has the authority and accountability for the management of all operational, financial, regulatory and business activities of the phase 3 clinical trial, SPARX3. Specifically, the Clinical Research Manager is responsible for oversight of all administrative and operational duties of the clinical trial unit including: management of the study, analyzing feasibility; identifying & securing needed resources; creating, implementing, monitoring, and updating project plans and budgets; facilitating meetings with appropriate parties; monitoring & reporting progress as appropriate; ensuring resolution of problems and issues and completion of contract requirements and client specifications; financial analysis and strategy; human resource management; managing facilities; business development and marketing; contract negotiations with sponsors and strategic partners; providing direction to and ensuring integrity in data management, mining, and analysis; interfacing and ensuring compliance with granting organization. Oversees all activities associated with the clinical research study considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; &/or multi-million dollar budgets (examples include Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials.). Creates, promotes and nurtures collaborations and partnerships with other institutional departments, outside affiliates and research organizations, pharmaceutical partners, regulatory agencies, and other strategic partners.
Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
In partnership with Principal Investigators (PIs) provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
Oversees management of studies including start-up, implementation, conduct, day-to-day activities, interaction with partners and sponsoring agencies, close-out; and planning, development and implementation of new processes and protocols to support research studies and maximize/extend study capabilities.
Ensures that the conduct of study protocols are in compliance with appropriate rules and regulations and reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
Manages conduct of experimental tests & procedures.
Closely monitors & documents patient's adverse events; partners with study staff in modifying intervention and testing schedule when applicable.
Oversees, assists and/or conducts exercise assessments, maximal graded exercise tests, and exercise related interventions.
Troubleshoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
Leads clinical team in preparing for internal, NU IRB, Sponsor, and FDA audits.
Oversee & implement resource and allocation and necessary changes in resource utilization required for clinical trials (equipment, etc.)
Responsible for implementing and monitoring approved study budget, which may include deciding on & approving expenditures of funds based on budget.
Invoices study sponsors for study tests/procedures.
Coordinates & participates in budgetary negotiations with industry sponsors.
Oversees the operational payment structure, monitors payments and patient billing as outlined in project contract.
Develops and maintains Standard Operating Procedures (SOPs) for the study’s clinical operations and continuously reviews and monitors clinical conduct and develops new, or modifies existing policy documents, SOPs, and training materials as required.
Oversees the development of training programs for both new and existing staff within the study. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
Reviews scientific literature and evaluates and recommends applicable techniques and procedures.
May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants.
Responsible for the maintenance of all lab facilities and equipment.
Acts as liaison between institutional investigators and clinical research staff, when necessary.
Trains, directs, assigns duties to and supervises research staff, students.
Provides leadership to the staff.
Oversees and directs recruitment activities in collaboration with appropriate PIs, management, and supervisory staff.
Develops and directs a comprehensive program of staff development including orientation, in-services, continuing education, and staff meetings.
Ensures that daily operations are appropriate, efficient and effective and are in compliance with improvement opportunities to enable the study to achieve its goals and standards.
Ensures staffing is appropriate to support trial volume.
Identifies opportunities for alternative staffing, sharing resources, right sizing, and staffing to demand.
Performs other duties as assigned.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as business, accounting, healthcare administration or related field; OR appropriate combination of education and experience.
5 years of business management experience including budgets, finance, grants, facilities, &/or human resources; or other relevant experience required.
Prior supervisory or project management experience required.
Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Working knowledge of multi-site Clinical Trials.
Attention to Detail: Consistently displays accuracy and attention to detail
Proven ability to lead a changing organization, including building a management team, developing initiatives and implementing improvements to drive the underlying strategy.
Proven ability to function in a complex business and compliance environment
Excellent management and communication skills
Ability to comprehend technical research protocols;
Knowledge of operational management, including budgeting; project management; broad knowledge of management principles and techniques;
Ability to plan, organize and execute policies and programs for a growing organization;
Strong analytical and problem solving abilities.
Ability to establish and maintain relationships across multiple organizations;
Ability to motivate and lead an organization as well as skill in dealing effectively with people at all levels.
Strong conflict resolution, change management and negotiation skills are required;
Ability to critically review reports and prepare recommendations from such review including but not limited to preparing and analyzing budgets and financial reports;
Ability to communicate clearly and concisely both orally and in writing;
Ability to make independent decisions with little oversight.
Skill in applying administrative principles in organizing and leading a complex team-based operation.
Communication-Oral and Written: Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
Decision Making: Follows and teaches others to follow a process method for problem solving.
Leadership: Involves team members in solving problems and making decisions, inspires people to follow the lead, obtains input from others, facilitates change, and inspires confidence and optimism through a clear vision and by personal example.
Organization: Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
Planning: Devises and implements clearly defined strategies to achieve business objectives.
Problem Solving: Formulates realistic plans and contingencies and establishes
A master's degree in related field such as health science, clinical exercise physiology, business administration, or healthcare administration.
PhD in related field.
3-5 years’ experience in clinical research preferred.
ACSM Clinical Exercise Physiologist Certification
Preferred Competencies: (Skills, knowledge, and abilities)
Prior experience working on NIH-funded, multi-site exercise research studies
Prior experience working with research teams recruit
Internal Number: 38333
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.