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Senior Research Project Coordinator

2 months ago

Akron, Ohio, United States Cleveland Clinic Full time


Become a vital part of Cleveland Clinic, a leading healthcare institution dedicated to providing exceptional care to our community.

Our commitment to patient-centered care is reflected in our collaborative approach among healthcare professionals.

As a Senior Research Project Coordinator, you will excel in managing and ensuring compliance with complex human subject research initiatives that typically involve a significant workload.

Your role will encompass assisting in the design and development of research protocols as necessary. In our dynamic team, the Senior Research Project Coordinator plays a crucial role throughout the research lifecycle.

From study initiation to completion, you will engage in various activities including regulatory compliance, participant interaction, and collaboration with investigators.

This may also involve developing protocols and managing study logistics.

The ideal candidate will:

  • Exhibit the ability to work autonomously.
  • Demonstrate superior coordination and compliance in managing complex human subject research projects.
  • Possess a strong understanding of our operational systems and processes.
You will thrive in a fast-paced, technologically advanced environment that fosters discovery, learning, and professional growth.

As you navigate your career path, you will find opportunities to shape your future here at Cleveland Clinic.

This position requires onsite presence.

Expect to work four days in the office and one day remotely, with the understanding that you may need to be onsite for participant interactions.

At Cleveland Clinic, we prioritize what matters most.

We treat our caregivers as family and continually seek ways to support you.


Here, you will find:

resources for professional development, a rewarding career for all, and comprehensive benefits that support your health, well-being, and future.

Joining Cleveland Clinic means becoming part of a supportive family united by shared values and a commitment to being the best place for care and employment in healthcare.


Key Responsibilities:


Independently manage large, intricate, multi-center clinical research protocols and oversee the execution of research projects, ensuring adherence to protocol requirements, which may include maintaining regulatory documents, data management, IRB submissions, and effective communication with the research team.

You may also be responsible for reporting Serious Adverse Events and completing necessary FDA and sponsor documentation in compliance with GCP standards. Communicate effectively with sponsors, monitors, and research personnel to ensure compliance across all study aspects.

Act as a liaison among investigators, research staff, external study personnel, and central research administration to assist with protocol interpretation, enrollment, and safety inquiries. Collaborate with the primary investigator, sponsors, and research staff to plan, execute, and assess project protocols, including participant recruitment.
Monitor and report on project progress, complete regulatory documents, and oversee protocol-related activities.

As delegated, you may need to achieve and maintain clinical competencies for unlicensed caregivers, such as phlebotomy, vital signs, ECG, and POC testing as required.

Ensure the quality of research data through oversight and monitoring.
Understand fundamental concepts of study design.
Develop and maintain a thorough knowledge of research protocols to ensure comprehensive and compliant execution of assigned projects.
Assist in audit preparation and responses.
May contribute to the development and maintenance of research tools, such as spreadsheets, questionnaires, and brochures.

Maintain certification records for study personnel (License, CV, CITI) and foster professional relationships through effective communication with internal and external stakeholders.

Assist in creating training and educational materials for assigned research protocols and document education as necessary.
Conduct and document the informed consent process.
Support the PI in research study design and protocol development.

May submit studies to relevant agencies in support of research programs and assist with annual and other reporting requirements.

Contribute to or assist with the development of research project budgets.
Perform additional duties as assigned.

Education:
High School Diploma or GED. An Associate's or Bachelor's degree in a healthcare or science-related field is strongly preferred.
A Bachelor's degree may offset two years of experience requirements.

Demonstrated proficiency in various computer-based skills, particularly in word processing, spreadsheets, database management, and presentation software, along with the ability to conduct internet research.

Strong written and verbal communication skills are essential.
Must be self-directed with a proven ability to collaborate effectively within a multidisciplinary team.

Within 90 days of hire, successful completion of certification in Human Subjects Research is required as per Cleveland Clinic's Responsible Conduct of Research guidelines.

Continually demonstrate competency in the defined requirements for the position as established by Cleveland Clinic.

Certifications:

None

Complexity of Work:
Self-directed in planning, prioritizing, and executing job responsibilities with minimal supervision.
Exhibit a desire to enhance job knowledge and skills through training and development.
Must be capable of working in a high-pressure environment and respond appropriately.

Work Experience:
A minimum of five years' experience as a Research Coordinator II or in a similar role. A Bachelor's degree in a healthcare or science-related field may offset two years of experience requirements.

Physical Requirements:
A high degree of dexterity for producing materials on a computer.
Normal or corrected vision and hearing within the normal range are required.
Involves extensive sitting and frequent walking, with occasional lifting or carrying of up to 25 pounds.
May involve some exposure to communicable diseases or body fluids.
May require working irregular hours.

Personal Protective Equipment:
Adhere to standard precautions using personal protective equipment as required.

Pay Range:
Minimum hourly: $27.65
Maximum hourly: $42.17
The pay range displayed reflects the anticipated range for new hires. Cleveland Clinic recruiters will clarify whether compensation is hourly or salary. Actual compensation will be determined based on factors such as work history, experience, skill set, and education. This does not include the value of Cleveland Clinic's benefits package, which includes healthcare, dental, vision, and retirement options.