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Overview

Job Summary

This Clinical Trials Pipeline Coordinator (CTPC) position will be directly involved in the management and implementation of cooperative group and industry clinical trial protocols at Baptist Clinical Research Institute. The CTPD works with Investigators, staff, and industry and/or government funding agencies to ensure accurate progress of clinical trials from the planning stage through study opening. The CTPC must have experience in clinical trials and protocol start-up activities to work with trial Principal Investigator (PI) and research staff, i.e. directors, regulatory team, budget and contract specialists, and pharmacy to track and oversee the implementation and completion of all start-up activities. Dual reporting to BCRI Multispecialty and Oncology Directors

Job Responsibilities

+ Liaises with internal and external clinical, budget and contracting, safety, and regulatory groups for coordination of clinical trial activities

+ Responsible for preparing and facilitating weekly pipeline review meetings with various administration and staff of research department to promote rapid clinical trial start-up

+ Networks with physicians and staff to achieve strategic goals and maximize efficiency. Collaborates with supervisor and other members of the organization to carry-out trial start-up activities

+ Prepares and manages site activation checklist document which houses studies in the pipeline

+ Collaborates and builds working relationships with external groups, such as study sponsors including pharmaceutical companies and clinical research organizations (CROs)

+ Coordinates efforts of team members with various tasks in the study activation process, including budget/contact team, regulatory team, and administration

+ Inquire about protocol-specific credentialing requirements and statuses (radiotherapy, radiology, etc.) as needed

+ Maintains established timelines for assigned projects

+ Manage communication with study sponsors as needed through site selection process, site initiation and other study start-up activities

+ Assists in study feasibility

+ Maintains communication with colleagues regarding protocol specific information and activation progress updates.

+ Assist and/or manage feasibility activities, including site questionnaire surveys

+ Forecasts submission/approval timelines and ensures adherence to; provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.

+ Serves as liaison to other departments such as IRB, Disease-Specific Group (DSG), Clinical Trial Committee CTC, outside organizations, and sponsor representatives.

+ Using various databases, application systems, and templates, such as clinical trials management systems, trial databases, and EMR systems.

+ Maintaining workload and tracking timelines of events during the start-up of new trials in the pipeline

+ Performs other duties as assigned.

Experience

Minimum Required: Three (3) years of experience in clinical research to include, but not limited to clinical research coordination, clinical research associate, or regulatory coordinator

Education

Minimum Required: Bachelor's degree in scientific field of study related to the research of the clinic or equivalent

Preferred/Desired: Master's degree in related field.

Training

Preferred/Desired: Understanding of clinical research methods and operations.

Special Skills

Minimum Required:

• Ability to multi-task and manage multiple projects or tasks at once

• Time management and ability to manage multiple competing priorities within various clinical trials • Knowledge of all applicable requirements, regulations, and laws.

• Skill in effective use of applicable technology/systems.

• Ability to effectively communicate both verbal and written thoughts, ideas, and facts.

• Ability to work cooperatively with others and independently

• Proficiency using applications in the Microsoft Office and Windows environments, including advanced skills in Microsoft Word, Excel, and PowerPoint

• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities

• Ability to adjust priorities to meet changing demands without losing focus on objectives

Licensure

Preferred/Desired: SoCRA or ACRP certification preferred.

REQNUMBER: 33062