Clinical Research Coordinator

Clinical Research Coordinator at TriHealth Hatton

We are seeking a dedicated Clinical Research Coordinator to join our team at TriHealth Hatton. The role involves coordinating and managing all components necessary for the successful participation and completion of clinical research trials. Acting as an educator, consultant/liaison, and evaluator, you will ensure clinical trials are conducted with safety, integrity, and efficiency, applying good clinical practices.

Key responsibilities include coordinating Phase II-IV trials, from initial sponsor contact for site selection to study preparation, execution, and close-out. You will also be responsible for marketing and networking with sponsors, determining protocol feasibility, and addressing some budgetary issues. Adherence to the standard operating procedures of the TriHealth Hatton Research Institute is essential.

Location: This position is based at Good Samaritan Hospital-Hatton Institute and requires travel to all infusion locations within the TriHealth network.

Work Hours and Shift:

• Full-time, Monday - Friday, Day shift.

Minimum Qualifications:

• Bachelor's Degree in Biological Science; Hard Sciences, Psychology, or Sociology (Equivalent experience accepted in lieu of degree).
• Basic Life Support for Healthcare Providers (BLS) certification.
• Clinical Research experience preferred

Job Responsibilities:

• Develop processes to facilitate the implementation of research protocols to ensure effective and safe medical research for all subjects. Identify and address potential or actual issues that may hinder accurate implementation of research protocols and initiate interventions to prevent protocol violations and/or unsafe practices.
• Coordinate necessary activities between Study Coordinators and the Principal Investigator.
• Perform initial and ongoing evaluations of research subjects and implement care aimed at achieving optimal outcomes. Plan care for research subjects/families based on clinical consultation, standards of care, optimal outcomes, and protocol requirements. Implement and evaluate the plan of care, perform technical skills according to policy and procedure and TriHealth standards, and document appropriately in medical records.
• Ensure compliance with IRB/FDA standards and deadlines in study submissions, subject randomization and enrollment, progress reports, and reporting of deaths and adverse events. Facilitate communication between study sponsors and designated TriHealth IRB.
• Assess potential subjects for inclusion and exclusion criteria. Maintain complete and thorough Case Report Forms in accordance with IRB and FDA standards. Support hospital staff in complying with research protocols, minimizing impact on their workload, and maintaining accurate follow-up schedules to meet regulatory time points.
• Demonstrate knowledge of available studies, screen potential patients for eligibility, and guide physicians and staff in capturing protocol-related data points. Attend required training by sponsoring organizations for specific protocols and meetings related to the initiation or ongoing progress of sponsored clinical trials.
• Act as the point person for audit staff during institutional reviews, preparing written responses with plans of action for any deficiencies.

Working Conditions:

• Climbing - Occasionally
• Concentrating - Frequently
• Continuous Learning - Frequently
• Hearing: Conversation - Consistently
• Hearing: Other Sounds - Frequently
• Interpersonal Communication - Consistently
• Kneeling - Occasionally
• Lifting <10 Lbs - Occasionally
• Lifting 50+ Lbs - Rarely
• Lifting 11-50 Lbs - Rarely
• Pulling - Occasionally
• Pushing - Occasionally
• Reaching - Frequently
• Reading - Frequently
• Sitting - Frequently
• Standing - Frequently
• Stooping - Occasionally
• Talking - Frequently
• Thinking/Reasoning - Consistently
• Use of Hands - Frequently
• Color Vision - Occasionally
• Visual Acuity: Far - Consistently
• Visual Acuity: Near - Consistently
• Walking - Frequently

TriHealth SERVE Standards and ALWAYS Behaviors:

At TriHealth, we believe there is no responsibility more important than to SERVE our patients, our communities, and our fellow team members. To achieve our vision and mission, all TriHealth team members are expected to demonstrate and live the following:

Serve: Welcome everyone by making eye contact, greeting with a smile, and saying "hello."

• Acknowledge when patients/guests are lost and escort them to their destination or find someone who can assist.
• Refrain from using cell phones for personal reasons in public spaces or patient care areas.

Excel: Recognize and take personal responsibility to address and recover from service breakdowns when a customer's expectations have not been met.

• Offer patients and guests priority when waiting (lines, elevators).
• Work on improving quality, safety, and service.

Respect: Respect cultural and spiritual differences and honor individual preferences.

• Respect everyone's opinion and contribution, regardless of title/role.
• Speak positively about team members and other departments in front of patients and guests.

Value: Value the time of others by striving to be on time, prepared, and actively participating.

• Pick up trash, ensuring the physical environment is clean and safe.
• Be a good steward of resources, using supplies and equipment efficiently and effectively, and look for ways to avoid waste.

Engage: Acknowledge wins and frequently thank team members and others for contributions.

• Show courtesy and compassion to customers, team members, and the community

Job keywords:

Clinical Trials, Research Protocols, Patient Care, Clinical Evaluation, Protocol Implementation, Study Management, Data Collection, IRB/FDA Compliance, Phase II-IV Trials, Multidisciplinary Team, Medical Research, Patient Safety, Regulatory Compliance, Study Preparation and Execution, Protocol Feasibility, Research Administration, Healthcare Research, Oncology