Clinical - Clinical Research Coordinator

Title: Pediatric Clinical Research Coordinator

Position: Full-Time, Hourly

Based at: TCR – Spartanburg | Reidville Road

Position Summary: The Pediatric Clinical Research Coordinator will be primarily responsible for conducting Phase II, III and IV clinical trials within internationally accepted standards of knowledge and understanding of the research process and related regulations. A lead study coordinator will have oversight of assigned clinical trials conducted at Tribe Clinical Research, under the direction of the Primary Investigator and Site Lead. This position will primarily support and coordinate clinical research studies involving pediatric participants and their families. The coordinator must be comfortable working with children of various ages, communicating effectively with parents and guardians, and fostering a positive, professional, and patient-centered experience throughout the research process. Since this is primarily a patient contact position, it requires an outgoing, friendly personality and someone who enjoys working with a diverse population of people. To understand the inclusion/exclusion requirements of protocols, a strong understanding of medical terminology is required. Strong clinical skills are required, along with computer skills for communication and documentation.

Key Skills and Competencies:

• Experience: 1-2 years.
• Demonstrates initiative and commitment to professional development, with a willingness to obtain phlebotomy or CMA certification
• Strong understanding of medical and clinical research terminology
• Excellent verbal, written & interpersonal communication skills
• Exceptional attention to detail and accuracy
• Proficiency in Data Management and Informatics
• Adhere to Principles of Ethical Research Standards
• Highly organized individual with strong time management skills
• Continuous learning mindset and commitment to professional development
• Comfortable working independently under moderate supervision

Primary Accountabilities:

• Serve as lead coordinator for up to three Phase II-IV clinical trials
• Manage study supplies and maintain accurate documentation
• Conduct informed consent processes and medical record reviews
• Ensure protocol compliance and proper documentation
• Communicate directly with sponsors and monitors to support study
• Administer Investigational Products and perform clinical operations such as Drug Administration

General Accountabilities:

• Collaboration with QA
• Trains other clinical trial associates making sure all individuals are up to date on all aspects of a clinical trial.
• Oversee organization and workflow of trials with meticulous attention to detail and ordering of priorities.
• Navigate and address sponsor and study issues to resolution.
• Perform clinical responsibilities, such as blood draws, processing, vaccine administration.
• Maintenance of organized, complete study charts, and legible, accurate research documentation through written progress notes.
• Have working knowledge of protocol including background, rationale, and description of investigational drug/device.
• Thorough knowledge of Inclusion/Exclusion criteria with Investigator available for questions.
• Coordinate and document in-service training for appropriate staff.
• Submit all regulatory documents and correspondence to regulatory personnel in a timely manner.
• Identify protocol problems and inform TCR Research Team of problems limiting recruitment and work on strategies to overcome these problems.
• Maintain detailed drug accountability.
• Conduct ordering of all protocol required follow-up labs, tests, procedures, and medications accurately and per qualifications and delegation by PI.
• Collaborate with attending Investigator and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.
• Participate in weekly site meetings.
• Communicate with other professionals via phone, email, and face-to-face meetings to make sure the whole clinical trial team is consistently aware of any relevant information and issues.
• Ability to communicate effectively both verbally and in writing with advanced interpersonal communication skills. This includes the ability to perform computer-based work on a regular basis.
• Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.
• Ability to read and understand the protocol, including any amendments, to ensure familiarity with study procedures and an understanding of the potential risks and side effects of the investigational product.
• Ability to interact daily with physicians, nurses, study monitors and other sponsor representatives, administrators and other employees, community resources, patients and their families and significant others.
• Ensures credentials and licenses are current through regular training and education

This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description and other duties, as assigned, might be part of the job.

A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task. This position requires excellent time management and communication skills and confidentiality. This position may require travel, lifting (up to 50 pounds), sitting, standing, and walking associated with a normal clinical research / physician office environment. A person in this position may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens.

This position requires adherence to Tribe Clinical Research’s Core Values as outlined:

• We are passionate about working for a GROWTH ORIENTED company.
• We exhibit a HUMBLE but CONFIDENT approach to work.
• We communicate what needs to be said RESPECTFULLY.
• We love serving others and WORKING TOGETHER for the greater good.
• We can take constructive feedback well and have a POSITVE ATTITUDE even when the going gets tough.

Reporting Structure: Site Lead

Tribe Clinical Research is an Equal Opportunity Employer