Clinical Research Operations Manager

University of Chicago•Austin, TX

23h

About The Position

The Clinical Research Operations Manager is a specialized research professional responsible for directing research operations within the program. This position collaborates closely with the Principal Investigator (PI) to ensure research projects progress as planned by overseeing the coordination of daily clinical trial activities. The Manager supervises and assists in the development of study materials and flowsheets, while also overseeing trainees, nurses, coordinators, and research assistants. The role involves participating in writing articles, reports, and manuscripts, and/or presenting research findings at meetings and conferences. In performing these duties, the Manager works with the PI, department, and institution to provide guidance on the administration of compliance, personnel, and other related aspects of the clinical study.

Requirements

College or university degree in related field.
7+ years of work experience in a related job discipline.
Ability to develop and manage clinical trials teams.
Excellent time management skills and ability to work independently.
Ability to develop and develop research programs and work strategically with Principal Investigators.
Ability to lead robust operational and financial analysis of study(ies) and/or program performance.
Ability to understand clinical trials protocols.
Knowledge of regulatory policies and procedures.
Strong analytical skills.
Knowledge of grant and contract administration.
Familiarity with medical and scientific terminology.
Demonstrated knowledge of Good Clinical Practices (GCP).
Ability to identify funding sources.

Nice To Haves

Master's degree in related field.
Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
Experience managing research teams and projects.
Experience in a leadership role.

Responsibilities

Responsible to maintain a high level of knowledge of all research protocols and the day-to-day function of the lab.
Oversees the operations of ongoing research projects; including all study materials, assists coordinating and performing study duties as needed.
Ensures research projects progress according to plan.
Investigates, modifies and applies new procedures, techniques or applications of technology.
Establishes goals and operating procedures, practices, and guidelines.
In collaboration with senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in specialized area.
Manages personnel, planning, compliance and other administrative aspects of research project(s).
Maintenance of laboratory supply inventory and subsequent ordering.
Oversees activities related to data collection and analysis.
Coordinate the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting and validating research data, and ensuring protocol adherence.
Protect patients and data confidentiality by ensuring security of research data and personal health information.
Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
Understand the federal research regulations and identify the federal research organizations’ role in regulating human research participation.
Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Supervises and trains research trainees, nurses, coordinators and research assistants.
Oversees the day-to-day function of the program including team trainings, hours and meetings.
Participates in presenting research findings at meetings and conferences.
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.
Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
Performs other related work as needed.