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Overview

The Clinical Scientist is responsible for providing senior leadership and scientific expertise. The Clinical Scientist will coordinate with cross-functional teams in the development of strategy and oversight for the clinical study/program.

Responsibilities

Develop and maintain relationships with physician experts (such as National Principal Investigators, Steering Committee Members) to meet company objectives for the project;

Coordinate the presentation of information to DSMB, in accordance with the DSMB Charter, including, but not limited to, data summaries and presentations, study notifications, patient summaries, and attendance at meetings when necessary;

Provide technical and scientific support/guidance for a specific project or area of treatment/technology or disease;

Work with cross functional teams (Engineering, Regulatory, Business Units, etc.) to evaluate new clinical projects and study strategy (i.e. C1 study phase);

Develop clinical study designs and facilitate the transition of the project to clinical project management team (i.e. C2 study phase and C2-C3 study phase handoff);

Review and provide input to clinical study-related documents, plans and training materials (e.g., CIP, IB, CRF Specifications, Study-specific IC Template, Clinical Study Overview Presentation, Progress Report);

Provide support and review materials for Investigator Meetings and Site Initiation Meetings;

Lead efforts for the analysis, interpretation, presentation and reporting of clinical and imaging data to relevant stakeholders (project teams, executive management, physicians); collaborate with the CPM;

In studies with an imaging component:

Coordinate plan for receipt and review of imaging

Coordinate efforts in the selection, training and management of core laboratory for independent review of imaging, as applicable;

Work with relevant stakeholders to develop and execute publication and presentation plan for the study;

Review study data and milestones, and coordinate study strategy with relevant stakeholders; and

Maintain effective communication with cross functional teams and stakeholders.

Qualifications

Minimum Bachelor's Degree Life Sciences or Engineering degree required, MD or PhD preferred;

Minimum 5 years experience in the conduct and management of clinical studies; Advanced degree applicants minimum 2 years applicable experieince;

Proven ability to exercise sound judgment in independent decision making;

Working knowledge of the regulatory authorities and other regulatory requirements that may impact global clinical studies;

Conscientious, influential person with an outstanding work ethic and strong personal discipline;

Willingness and capability to handle multiple projects and responsibilities;

Excellent organizational, leadership and problem-solving skills;

Excellent written and verbal communication skills;

Sufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic manner;

Excellent relational skills and desire to mentor others;

Ability to present a professional and personable demeanor in all interactions;

Experience in writing study protocols and other technical documents;

Willingness and ability to travel 10-20% of the time; and

Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Requisition ID2025-16508

Posting Date1 month ago(4/18/2025 7:19 AM)

Job Location(s)West Lafayette IN United States

Job LocationsUS-IN-West Lafayette

Position TypeFull Time

CompanyCook Research Inc.

CategoryClinical