• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building: Medical Center
• Salary Range: $95,000 - $100,000

Position Summary

The Clinical Research Manager is a professional who oversees and coordinates the execution of the Department of Radiation Oncology clinical research studies and trials. The Clinical Research Manager is responsible for ensuring that clinical trials are conducted ethically, safely, and in compliance with regulatory guidelines. This position supervises the clinical research administration team, including the Clinical Research Coordinators, and ensures accountability to standard operating procedures related to clinical research.

Responsibilities

RESEARCH MANAGEMENT

• Manages and executes clinical trial research studies conducted by Principal Investigator (PIs) according to research objectives and protocols.
• Manages the lifecycle of clinical trials including:

1. study request feasibility assessments and approvals
2. study planning including development of protocol, informed consent form, budget (and cost estimate forms), and contract
3. study start up including submissions to the Clinical Trials Office, Protocol Review and Monitoring Committee, Data and Safety Monitoring Committee, Fiscal Support Committee, and Institutional Review Board
4. study initiation including NCI study registration, site initiation visits, and internal systems
5. screening and recruitment of study subjects
6. study management including data collection, payment invoicing, core services
7. monitoring, audits, and inspections
8. study closure

COMPLIANCE

• Ensures clinical research studies are conducted according to regulatory requirements, good clinical practices and specified research protocols, outside sponsors and federal and/or state regulatory agencies.
• Assists PIs in competing annual effort reporting requirements and institutional training and compliance.

STUDY PROPOSALS AND APPROVAL

• Assesses the feasibility of and manages the approval process for proposed studies.

STUDY DEVELOPMENT

• Collaborates with PIs and sponsors on the development of protocols, informed consent forms, and contracts.
• Coordinates and establishes clinical trials schedules, task assignments, and allocation of staff and equipment.

RESEARCH FINANCE

• Prepares study budgets, research related cost estimate forms, start-up activities, and initiation of all new research studies and trials.
• Monitors and reconciles budget and other financial items for clinical trials; tracks reimbursements from sponsoring agencies.
• Responsible for payment invoicing.

STUDY SUBMISSIONS

• Responsible for submitting studies to CUIMC CTO, PRMC, DSMC, IRB, and fiscal support committees.

STUDY INITIATION

• Registers studies and conducts site initiation visits.

STUDY RECRUITMENT

• Identifies potential study participants; screens potential participants to determine eligibility.
• Manages consenting, enrolling, and general conduct research visits for clinical trials and research.

DATA COLLECTION

• Manages the completion of data entry in electronic data capture systems including Velos, Redcap, and Qualtrics.
• Ensures complete and compliant filing of study documents and forms.

ONGOING MANAGEMENT

• Manages all study subjects enrolled in clinical trials, including completion and tracking of all required regulatory documents.
• Monitors the overall trial. Provides status reports, adverse side effects and trends, evaluates patient enrollment, and provides appropriate recommendations and/or conclusions.
• Maintain research study supply inventory.

MONITORING, AUDITING, AND INSPECTIONS

• Directs team to prepare for external site monitoring visits
• Responsible for successful completion of audits, reviews, and inspections

STANDARD OPERATING PROCEDURES

• Develops and enforces policies and procedures for clinical trials practices in accordance with regulatory, departmental, institutional and federal guidelines.
• Conducts meetings with staff to ensure compliance with established practices and to keep employees abreast of current changes and standards.
• Develops processes, procedures, tools, and training to enhance clinical research activities.
• Develops quality assurance and quality improvement processes for research team members.
• Identifies necessary resources and requests as appropriate.
• Ensures optimal productivity of research administration. Identifies opportunities to improve efficiencies by developing and implementing solutions to improve workflow and reduce costs.
• Identifies noncompliance concerns, assesses cause, creates corrective action plans, and implements independently.

PEOPLE MANAGEMENT

• Manages and provides direct supervision of the research administration team including the Clinical Research Coordinators.
• Manages various research administration personnel functions such as hiring, time away requests, performance reviews, coaching and mentoring, disciplinary actions, and terminations.
• Provides training, resources, and updates for PIs and staff during the onboarding process and as an ongoing learning initiative.

MEETINGS/PRESENTATION

• Conducts and leads regular meetings with PIs and research teams.
• Presents regular updates to PIs and co-/sub-Investigators for clinical trials, including enrollment goals and progress, concerns or ideas for development, and upcoming opportunities.
• Prepares a presentation and leads bi-weekly Radiation Oncology research meetings highlighting progress and updates.
• Clearly and effectively communicates with potential study subjects, clinicians, other health care providers, ancillary staff, sponsors, other institutional offices, and research office staff.
• Serves as the department's point of contact for all research initiatives related to the medical center, cancer center, and other clinical departments.

OTHER

• Performs additional duties & responsibilities related to research as assigned/requested.

Minimum Qualifications

• Bachelor's degree in nursing, biological science, public health, or business/administration degree such as finance, accounting, business administration, public administration, or a directly related field.
• A minimum of 4 years of relevant research management experience.

Preferred Qualifications

• Masters degree in nursing, biological science, public health, or business/administration degree such as finance, accounting, business administration, public administration, or a directly related field preferred.
• 6+ years of experience managing clinical trials, including 2 years in a management/supervisory leadership role.
• Bilingual.
• Ability to communicate in Spanish with a large Hispanic patient population.

Other Requirements

• • Scientific and medical knowledge, including possessing basic knowledge of science principles in biochemistry, pharmacology, and chemistry to make decisions without direct assistance from researchers.
  • Leadership skills, including strong communication, feedback, and conflict management skills, and the ability to foster collaboration, promote a culture of goal-achievement, and lead others through new and changing situations.
  • Demonstrated discretion including independent decision-making and research recommendations.
  • Capable of handling large and complex trials, other clinical trial employees, multiple participants, and large amounts of data.
  • Strong communication skills, ability to actively communicate the requirements and steps of the trial to the participants and stakeholders involved. Ability to communicate effectively both in verbal and written formats.
  • Strong customer service orientation and skills, with the ability to interact and collaborate positively, constructively, and effectively with multiple audiences. Ability to model strong service to others and coach others through challenging client situations.
  • Strong interpersonal, empathetic, and emotional intelligence skills focused on establishing and maintaining relationships with faculty, peers, leadership, patients, and other stakeholders. Ability to adapt to meet the needs of clients, deescalate challenging situations, and mentor others in client management.
  • Capacity to work with a high degree of independence and successfully within a deadline driven, multi-tasking environment. Ability to handle multiple projects at high levels of complexity, demonstrate sound judgment in managing time, prioritizing, and decision-making.
  • Excellent analytical skills, with ability to interpret data, noting important patterns or outcomes that should be brought to the attention of those responsible for the trial.
  • Strong organizational, time management, and attention to detail skills.
  • Self-motivated and demonstrates initiative, patience, and resourcefulness in adapting to changes.
  • Proficiency in problem assessment and collaborative problem solving in interdisciplinary settings. Ability to proactively communicate progress and roadblocks and escalate complex issues to management and research offices.
  • Ability to collaborate on and deliver presentations to various audiences, including senior leadership.
  • Proficiency in Microsoft Office (Word, Excel, and PowerPoint) or similar software and an ability and willingness to learn new systems and programs.