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Overview

This position is responsible for the study-level management (prior to submitting to IRB/EC to closeout) of clinical studies, encompassing effective management of stakeholder communication and use of appropriate tools to ensure the successful initiation, planning, execution, monitoring, and closure of studies.

Responsibilities

Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA CFR, ISO 14155, GCP, EU MDR) that impact clinical studies assigned;

Provide vigilance over investigational, interventional, or multiregional observational post-market clinical studies and track study progress; work with the appropriate clinical study team members and/or management to ensure study activities are being conducted in a timely manner to achieve study objectives and milestones; comply with the global clinical affairs quality system procedures/instructions; and provide oversight that the study observes the applicable regulations and standards;

Lead efforts to document and train the internal clinical study team, vendor CRAs and/or CPMs and site study team;

Lead and manage internal and vendor activities in support of assigned studies (e.g., site initiation, site visits, auditing, patient-reported outcomes, and patient recruitment);

Supports and participates in strategic project management initiatives;

Develop and maintain a working knowledge of study specific and disease pathology and anatomy;

Ensure that appropriate resources are available to achieve study objectives and milestones and deliverables;

Develop and coordinate clinical study-related documents, plans, and training materials (e.g., Study Protocol, Study/Site-specific Informed Consents, Monitoring Plan, Risk Management Plan);

Maintain effective communication with cross functional teams and stakeholders;

Ensure proper and timely escalation of critical issues to Clinical Operations management;

Provide project trackers for business divisions and manufacturer and lead regular teleconferences to discuss project progress and estimated deliverable dates;

Participate in the review of clinical study reports which includes progress, annual, or final;

Monitor project timelines and scope through the project management software, update study status at least biweekly, and alert management if timelines fall behind schedule;

Assist in preparation and submission of regulatory applications for the clinical study, where appropriate;

Lead efforts, drive the content, and collaborate with the appropriate personnel for external meetings (e.g., RC, Investigator, SIM);

Lead efforts and plans for clinical study meetings and preparation of study materials for distribution to clinical sites;

Ensure the clinical study is registered and maintained on a public database, if applicable;

Participate in site selection and principle investigator changes during the clinical study; and

Ensure clinical study data within clinical systems (e.g., EDC, DMS) are accurate and up to date.

Qualifications

A minimum of a Bachelor’s degree (scientific-, health-, or business-related field preferred) plus significant relevant experience is required; Master’s degree with demonstrated research or project management background is preferred;At least 3 years of previous experience in the conduct of medical device/drug clinical studies (including a knowledge of applicable regulations and standards) is preferred;Ability to exercise sound judgments and quick decisions independently;Outstanding work ethic and strong personal discipline;Ability to interact with internal and external stakeholders (e.g., study team, physicians, scientists, division representative) in a professional and personable demeanor;Capability to handle multiple projects and responsibilities;

Proficient in the following skill sets: time management, leadership, written and verbal communication,problem-solving (e.g., root cause analysis, lean management);Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues;Sufficiently assertive to deal with confrontational situations;Willingness and ability to travel as needed;Ability to stay resilient and maintain a professional attitude during challenging situations; 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 ID2025-16090

Posting Date5 days ago(2/17/2025 6:40 AM)

Job Location(s)West Lafayette IN United States

Job LocationsUS-IN-West Lafayette

Position TypeFull Time

CompanyCook Research Inc.

CategoryClinical