Job Description
Job Overview:
Coordinates and manages all components required for an organized multi-disciplinary team approach for the successful participation and completion of clinical research trials in TriHealth. Functioning as an educator, consultant/liaison, and evaluator, the Clinical Research Coordinator strives to coordinate clinical research trials with safety, integrity and efficiency while applying knowledge of good clinical practices. Coordinates Phase II thru IV trials from initial sponsor contact for site selection, study preparation and execution to study completion and close-out. Responsible for marketing and networking with sponsors. Determines protocol feasibility and some budgetary issues. Adheres to the standard operating procedures of the TriHealth Hatton Research Institute.
Job Requirements:
Bachelor's Degree in Biological Science; Hard Sciences, Psychology, Sociology
Equivalent experience accepted in lieu of degree
Basic Life Support for Healthcare Providers (BLS)
Job Responsibilities:
Demonstrates the ability to develop processes to facilitate implementation of the research protocol to provide effective and safe medical research to all subjects. Demonstrates the ability to identify potential and/or actual issues which may prohibit the accurate implementation of the research protocol and initiate interventions to avoid protocol violations and /or unsafe practice. Demonstrates the ability to coordinate necessary activities between Study Coordinators and the Principal Investigator.
Performs initial and ongoing evaluations of research subjects and implements care directed towards optimal outcomes. Plans care for research subjects/family based on clinical consultation, standards of care, optimal outcomes and protocol requirements. Implements and evaluates plan of care. Performs technical skills according to policy and procedure and accepted TriHealth standards. Documents in medical record appropriately.
Complies with all IRB/FDA requirements in study submission. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with IRB/FDA standards and deadlines in completing Progress Reports. Assures compliance with IRB/FDA standards and deadlines in reporting all deaths and adverse events with study subjects. Assures compliance with IRB/FDA standards and deadlines in facilitating communication between study sponsor and designated TriHealth IRB.
Assesses potential subjects for inclusion and exclusion criteria. Keeps Case Report Forms complete and thorough using the IRB and FDA standards. Supports hospital staff in complying with research protocols and works to minimize the impact on their workload. Keeps queries and protocol violations that can be controlled to a minimum. Responds appropriately and accurately to all queries in a timely fashion. Maintains accurate and detailed follow up schedules to assure meeting regulatory time points.
Demonstrates knowledge of available studies, screening potential patients for eligibility, guiding physicians and staff in needed timetables for capturing protocol related data points. Attends trainings required by sponsoring organizations for specific protocols and/or attends meetings related to the initiation or on-going progress of a sponsored clinical trial. Acts as the point person for audit staff coming into institution for a review prepares a written response with a plan of action to any major/minor deficiencies.
Other Job-Related Information:
Working Conditions:
Climbing - Rarely
Hearing: Conversation - Consistently
Hearing: Other Sounds - Consistently
Kneeling - Occasionally
Lifting 50+ Lbs - Rarely
Lifting <50 Lbs - Occasionally
Pulling - Occasionally
Pushing - Occasionally
Reaching - Occasionally
Sitting - Frequently
Standing - Frequently
Stooping - Frequently
Talking - Frequently
Use of Hands - Consistently
Color Vision - Rarely
Visual Acuity: Far - Occasionally
Visual Acuity: Near - Consistently
Walking - Consistently
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: ALWAYS...
• 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: ALWAYS...
• 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: ALWAYS...
• Respect cultural and spiritual differences and honor individual preferences.
• Respect everyone's opinion and contribution, regardless of title/role.
• Speak positively about my team members and other departments in front of patients and guests.
Value: ALWAYS...
• 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 our resources, using supplies and equipment efficiently and effectively, and will look for ways to avoid waste.
Engage: ALWAYS...
• Acknowledge wins and frequently thank team members and others for contributions.
• Show courtesy and compassion with customers, team members and the community
Job Tags
Full time,