LOOKING FOR A CLINICAL RESEARCH COORDINATOR FOR A FULLY-ONSITE OPENING IN ROCHESTER, NY

General Purpose:

This role involves coordinating human subject research activities within a diverse research portfolio, including areas such as Pulmonary Arterial Hypertension, Lung Cancer Screening, Chronic Obstructive Pulmonary Disease, Sepsis, Air Pollution and Inhaled Toxins, Airway Inflammation and Lung Function in Asthma, Oscillometry in Airway Disease, Pulmonary Fibrosis and Lung Scarring, Pulmonary Embolism, and Hypoxemic Respiratory Failure. The primary focus will be on clinical trials related to Airway Inflammation and Lung Function in Asthma. Regular meetings with Principal Investigators will be required for oversight of trial recruitment, data management, subject interactions, and communication with regulatory bodies (e.g., CRO, IRB). Cross-coverage of other trials within the division will also be expected, under the guidance of the Divisional Clinical Research Manager.

Responsibilities:

• Coordinate human subject research activities for multiple clinical trials, focusing on Airway Inflammation and Lung Function in Asthma.

• Participate in the planning, development, and implementation of study designs, budgets, protocols, consent forms, processes, and policies.

• Distribute and explain study information, including protocols and recruitment materials, to team members and relevant stakeholders.

• Develop, implement, and evaluate recruitment strategies, information and data systems, and study management systems for assigned studies.

• Facilitate eligibility screening and study recruitment activities, including scheduling appointments and study visits.

• Conduct visits to ensure research participant adherence to protocol requirements.

Data Collection, Management, and Maintenance:

• Develop, review, and approve case report forms (CRFs) and study-specific procedure manuals and documents.

• Perform data collection and use required data systems for tracking study progression, monitoring, and reporting on deliverables, quality, and safety.

• Maintain relevant study logs through sponsor-related and University-related systems, including OnCore, according to UR and department SOPs.

Regulatory, Quality, and Compliance:

• Collaborate with the IRB to address issues with ongoing studies, prepare and submit annual reviews, and study amendments.

• Develop, implement, and monitor systems and methods to ensure quality, safety, efficiency, and consistency in processing human subject research data.

• Review study progress, including data, finances, documentation, and reporting deliverables.

• Design, develop, implement, monitor, and manage systems and procedures for tracking study progression.

• Standardize protocol activities across study sites and implement corrective actions when inconsistencies are identified.

Communication:

• Represent sites, providers, study teams, patients, study participants, and the University in coordinating human subject studies.

• Prepare for, participate in, and serve as a liaison for sponsor monitoring visits. Develop positive relationships with sponsors and attend study Investigator/Coordinator meetings as required.

• Maintain positive communications among the Principal Investigator, research staff, study sites, sponsors, and regulatory agencies.

Qualifications:

• Bachelor’s degree required.

• Minimum of 3 years of experience in human subject research coordination REQUIRED.

Please send your resume to gpacheco@ actalentservices.com if interested!

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.