"Manager Clinical Trials - Cardiology"

Position Summary

Directly responsible for the supervision, oversight, training and education of research coordinators, and quality assurance monitoring of data in the Functional Research Groups. This position requires the ability to clinically assess protocols for budgetary and logistical issues associated with the coordination and implementation of clinical trials for institutional studies, cooperative group studies, and pharmaceutical industry-sponsored studies.

Job Description

Primary Duties & Responsibilities:

Leadership of the Functional Research Groups

• Makes hiring and staffing decisions in the Functional Research Groups with input from the Administrative and Medical Directors of the Core.
• Orients and trains all staff in the Functional Research Groups, and assists in orienting new staff in the Regulatory and Protocol Development groups.
• Meet regularly with all staff, providing supervision and training.
• With the Administrative Director and Medical Director, plan strategically and implement plans for Functional Research Groups, including staffing, education, adherence to federal regulations and standard operating procedures for ensuring quality data collection.
• Provides feedback and performs annual performance evaluations for Research Coordinators with assistance from Senior Clinical Research Associates and the Administrative Director.
• Supports Senior Clinical Research Associate through initial performance improvement efforts and directs progressive performance management and disciplinary activities as required.
• Assesses new protocols for logistical and budgetary issues and creates a plan to address these.
• Creates budgets for new studies.
• Assists with evaluating and entering studies into the database.
• Meets regularly with Administrative Director (at least weekly); represents Functional Research Groups at senior level meetings.
• Meets regularly with the oncologist to assess the progress and goals of the research program.
• Leads regular meetings with the study team and members of each clinical area to plan for the successful implementation of upcoming studies.
• Managing clinical trials.
• Budget creation.
• FDA submissions.
• HRPO submissions.
• RDRC submissions.
• Internal audits/compliance.
• Running research portfolio of projects.
• BLS certified, CGP certified, CITI certified preferred.

Oversight of Daily Activities

• Oversees the daily research activities for Senior Research Coordinators including compliance with protocol criteria and adherence to federal regulations.
• Oversees daily protocol management activities of Senior Research Coordinators.
• Monitors collected data for accuracy of objective criteria.
• Facilitates accrual to high priority research studies.
• Oversees the quality assurance process for monitoring the collection of data for research, with assistance from the Quality Assurance and Safety Monitoring Committee (QASMC).

Other Functions

• Performs other duties as assigned.

Working Conditions:

Job Location/Working Conditions: Normal office environment

Physical Effort: Typically sitting at desk or table, Repetitive wrist, hand or finger movement (PC Typing)

Equipment: Office equipment

Required Qualifications

Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications: No specific certification is required for this position.

Work Experience: Clinical Research (1 Year)

Skills: Not Applicable

Driver's License: A driver's license is not required for this position.

Preferred Qualifications

Certifications: Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP)

Skills: Clinical Project Management, Clinical Systems, Clinical Trials Administration, Deadline Management, Interpersonal Relationships, Leadership, Microsoft Excel, Microsoft Word, Oral Communications, Prioritization, SQL Databases, Stress Management, Written Communication

Grade

G14

Salary Range

$75,200.00 - $128,800.00 / Annually