CLINICAL RESEARCH OPERATIONS COORDINATOR - FULL TIME

Supervisory Responsibilities

Precision Oncology Research personnel involved in administrative tasks, including but not limited to Clinical Research Assistant.

General Summary

A Clinical Research Operations Coordinator (CROC) is to oversee and manage the clinically relevant, administrative, functions involved in the pre-screening, screening, eligibility and coordination of care processes related to research subjects enrolled in clinical trials. These functions are essential for the proper enrollment and registration of research subjects scheduled for clinical trial visits, data collection and submission, study materials and kit organization and submission of samples to vendors, as well as the maintenance of subject records, all in the interest of ensuring the integrity of the research process and Principal Investigator Oversight in the conduct of clinical trials.


Additionally, the CROC will support the Sr. Director Research Site Operations, as well as the Clinical Research Team Members by working with research subjects, providers and other staff to promote timely access to research procedures and/or care, provide continuity of care coordination, and coaches healthcare providers and their team members to understand the patient care plan and fulfill Clinical Research Team Members responsibilities in coordination and communication to healthcare providers and research subjects, as applicable.

Essential Duties & Responsibilities

• Consistently arrives at work on time and adheres to regular work schedule.
• Use skills to develop research processes, tools and resources to support Clinical Research Team Members in clinical trial operations and the management of research subjects.
• Attend all required meetings, training sessions, and update research subject patient lists, processes or workflows, as applicable.
• Collaborates with Clinical Research Team Members to determine subject eligibility. Verify eligibility criteria and completes other requirements involved in pre-screening and/or screening research subjects in support of Clinical Research Team Members.
• Coordinate Weekly Clinical Research Meeting. Make note of action items and proceed, as indicated or directed, in fulfilling communications and/or coordination efforts related to Research Subject activities.
  1. Update Research Calendar with detail Research Subject Visits.
  2. Communicate visits via intradepartmental emails and communications, on behalf of Clinical Research Team Members.
  3. Scheduling Upcoming Research Subject Visits (e.g. Scans, other provider visits, as needed).
• Attend Sponsor mandated meetings or calls in order to provide updates and representing status updates on research subjects and, in turn, review all study materials in detail in order to prepare and update guidance documents, as needed, as well as provide updates to Clinical Research Management Team Members discussed during Sponsor calls or via Sponsor communications.
• Prepares and organizes Research Subject Binders. Gathers appropriate information from source documents, clinical staff, and other sources as necessary. Completes study specific forms and uploads study materials for submission to research vendors engaged by pharmaceutical Sponsors.
• Enter data into study specific Electronic Data Capture (EDC) systems and review queries, regularly, in order to meet data commitments as indicated in Clinical Trial Agreements.
• Process and prepare Research Samples for Shipment, update Laboratory Requisitions and Tracking, as needed.

Other Essential Duties May Include but Are Not Limited To

• Support Sr. Director, Research Site Operations, in meetings and/or administrative actions involved in Clinical Research Operations, as well as the integration of clinical trial program within a clinical practice and/or hospital setting.
• Prepare for Research Subject Binders, Research Lab Binders and assure EDC is current for Interim Monitoring Visits and represent Clinical Research Team Members, as applicable.
• Other duties as assigned.

Knowledge, Skills & Abilities Required

Required:

• Consistently arrives at work in appropriate/professional attire.

• Completes all tasks within established time frame.
• Adheres to all clinic policies and procedures.
• Must have well developed verbal and non-verbal communication skills.
• Must have excellent organization and problem-solving abilities.
• Strong customer service and team orientation essential.
• Must be a team player, flexible and able to handle multiple tasks.
• Must have appropriate computer skills, which include Microsoft Office, Word, Internet Skills and Database Experience.
• Knowledge of oncology related medical terminology.
• Must have experience in medical practice operations, healthcare management and/or clinical research site operations and workflow development.
• Demonstrate required work ethics and integrity of research data, and appropriate patient confidentiality.

Education:

• Bachelor's degree required, master's degree preferred. In lieu of a degree, 10 or more years of relevant experience may suffice.
• Certification in Human Subjects Protection, Good Clinical Practices (must be obtained within 30 days of hire).
• Previous research experience or exposure, preferably in Oncology clinical trials.