Sr. Clinical Trials Manager (Sr Clinical Research Assoc)

Northwestern University; Chicago (IL); On-site; USD 75,000 - 125,000; Full time

Job summary

Northwestern University is seeking a Sr. Clinical Trials Operations Manager in Chicago, IL to lead and coordinate complex clinical research operations. The role collaborates with PIs, administrative leadership, and study teams to ensure timely study progression from screening through completion.

Responsibilities include IRB facilitation, contract negotiations, protocol adherence, and data management. Candidates should have advanced degrees and proven trial management experience.

Qualifications

• Experience leading and coordinating clinical trials.
• Knowledge of IRB submission processes and study activation workflow.
• Familiarity with regulatory requirements governing human subjects research.

Responsibilities

• Direct clinical research operations to ensure studies progress on schedule.
• Coordinate IRB submissions, contract negotiations, and study activations.
• Oversee data collection, management and protocol adherence across trials.
• Supervise coordinators and research staff as needed.

Skills

Clinical trial management

IRB coordination

Regulatory compliance

Education

RN / MD / PhD / MS

Job description

Department: MED-Surgery

Salary/Grade: RES/RS

Target hiring range for this position will be between $75,000.00 - $125,000.00. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Location: Chicago, Illinois

Sr. Clinical Trials Operations Manager

The Sr. Clinical Trials Operations Manager is a specialized research professional that is responsible for the direction of clinical research operations. The position works closely with the administrative leadership and PIs and ensures clinical research projects progress according to plan by overseeing the coordination of the daily clinical trial activities, including facilitating IRB approval and contract negotiation processes, to ensure efficient and timely study progression. They may participate in any tasks/activities that need completion to expedite study activation.

The Manager oversees and aides in the development of study material/flowsheets and may supervise coordinators and research assistants.

Specific duties and responsibilities include but are not limited to:

• Responsible to maintain a high level of knowledge of all research protocols and the day-to-day function of research team
• 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.
• Manages personnel, planning, compliance and other administrative aspects of research project(s).
• 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
• Understand the federal research regulations and identify the federal research organizations' role in regulating human research participation.
• Has comprehensive knowledge of the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
• Performs other related work as needed.

Preferred Qualifications

• Relevant advanced qualification, including RN, MS, MA, MD or PhD degrees
• Experience and expertise in running clinical trials
• Ability to successfully complete the requirements of the Northwestern Memorial HealthCare Research Access Program

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.