Lead Research Coordinator, Hem/Onc

JOB SUMMARY

Provides oversight for all aspects of clinical research occurring within the specified program and training and mentoring for clinical research personnel at site. Provides guidance and assistance in protocol development, serving as back-up coordinator to provide ongoing support for all trials in the specified program as needed. Communicates all relevant policy and procedure updates/revisions as directed by Manager, Research. Provides routine auditing/monitoring of ongoing trials for quality assurance purposes.

EDUCATION

• Bachelor’s degree in a scientific or health-related field

CERTIFICATION SUMMARY

• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment
• Collaborative Institutional Training Initiative (CITI) within 30 days of employment

EXPERIENCE*

• 4 years of experience in clinical research or 3 years of experience in clinical research with a Master’s degree in Business Administration, Healthcare Administration, or a scientific field
• 3 years of experience in clinical research in a medical/behavioral setting with knowledge about the conduct of clinical trials, research principles, and methodologies/study design

PREFERRED QUALIFICATIONS*

• 2 years of experience in supervising staff
• Experience in creating and negotiating study budgets
• Experience in financial management

KNOWLEDGE SKILLS & ABILITIES*

• Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
• Self-directed and motivated to work independently toward short- and long-term goals
• Good communication, organization, and interpersonal skills

JOB RESPONSIBILITIES*

• Serves as an instructor and mentor for quality and education activities.
• Orients, supervises, and evaluates staff.
• Maintains all licensure, certification, and system education requirements for role.
• Coordinates educational activities related to study needs for study staff, investigator team, and patient care staff.
• Assists with departmental policy and quality projects.
• Collaborates with manager to incorporate system initiatives into departmental practices.
• Leads or chairs committees or task forces.
• Authorizes purchases for research supplies and equipment maintenance.
• Provides training and assistance for research protocol development, conduct, and facilitation at an expert level.
• Provides substantial support to investigators in writing study protocols.
• Identifies and completes research grant applications.
• Assists with participant screening, enrollment, study activities, and communication.
• Serves as back-up coordinator within identified service lines for all studies conducted in that service line.
• Ensures protocol feasibility within ancillary departments.
• Provides leadership, training, and assistance for data management activities.
• Assists with development of source and case report form tools.
• Provides back-up data entry services and ensures data integrity.
• Supports statistical services needs.
• Collaborates with manager to assess data management needs.
• Provides leadership, training, and assistance for direct patient care interaction.
• Administers various research surveys in accordance with research study requirements.
• Completes research-only testing as required and applicable per-study and system requirements including electrocardiograms.
• Performs phlebotomy if trained to do so.
• Provides research study education to participants as part of a study protocol.
• Completes documentation as needed within the medical record.
• Provides leadership and training related to all clinical research activities.
• Trains coordinators on all Institutional Review Board-related activities such as submission, modifications, reporting, and termination activities.
• Oversees the maintenance of all coordinators’ regulatory documents.
• Leads others in sponsor correspondence, monitoring, and study meetings.
• Conducts interdepartmental auditing for quality assurance purposes.
• Manages a large or multiple smaller clinical trial projects.
• Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials.
• Provides leadership and expertise in study budgeting, sponsor interactions, budget and contract routing, feasibility assessments, account management, and reconciliation.
• Monitors expenditures and adherence to budget.
• Tracks research billing to ensure research procedures are billed appropriately and resolves invoice-related issues with all parties involved.
• Works collaboratively with manager to monitor metrics.
• Assists with identifying suitable grants for investigators.
• Assist Supervisor and/or Manager with development of staff by: being available to teammates, acting as a resource to help complete complicated/complex tasks, providing on the job training to team, and seeking out opportunities to become actively involved in staff workflow and development.
• Provide Supervisor and/or Manager feedback on staff performance, educational needs, and workflow status.

SYSTEM RESPONSIBILITIES*

Safety: Practices proper safety techniques in accordance with hospital and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.

Compliance: Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process. Maintains records of compliance activities and reports compliance activities to the Compliance Office.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.

PHYSICAL DEMANDS*

Bending/Stooping – Occasionally (activity or condition exists up to 1/3 of time)

Climbing – Occasionally (activity or condition exists up to 1/3 of time)

Lifting – Occasionally (activity or condition exists up to 1/3 of time)

Pushing/Pulling – Occasionally (activity or condition exists up to 1/3 of time)

Sitting – Constantly (activity or condition exists 2/3 or more of time)

Standing – Occasionally (activity or condition exists up to 1/3 of time)

Walking – Occasionally (activity or condition exists up to 1/3 of time)

Hearing/Speaking – Effective communication with employees, supervisors/managers and staff. Effective communications with patients and visitors, as required.

Ability to lift up to 15 lbs independently not to exceed 50 lbs without assistance

WORKING CONDITIONS*

Some potential for exposure to blood and body fluids