Next Stage Clinical Research
Clinical Research Coordinator (CRC)
Next Stage Clinical Research, Wichita, Kansas, United States, 67232
Job Summary:
A Clinical Research Coordinator (CRC) plays a pivotal role in the successful implementation and management of clinical research studies. This role involves coordinating and overseeing all aspects of research studies, including patient recruitment, data collection, documentation, and compliance with regulatory and ethical guidelines.
Education: Bachelor's degree and/or license such as C-MA or LPN; One to two years experience working in a Research Assistant or CRC role or related industry role; OR an equivalent combination of the above education and experience Knowledge of medical terminology Strong team player with interpersonal skills Must be able to work in a high paced environment Exceptional organizational and time management skills, ability to prioritize tasks - detailed oriented Computer skills (familiar with electronic health record systems, Microsoft Office) Physical Demands:
Requires extensive mobility: walking, standing, bending, stooping, kneeling, crouching, or crawling. Ability to sit for long periods of time. Pushing, pulling, and lifting of equipment. Requires mental alertness and accuracy for decision making. Requires ability to speak and hear. Repetitive motion required for extensive use of computers. Good visual acuity. Ability to lift up to 50 pounds.
Mental Demands:
Requires English language skills for constant high-level written and interpersonal communications. Ability to work well with patients, sponsors, physicians, NCR Team Members, and representatives from other healthcare organizations. Must be able to multitask and to work independently with minimal supervision. Excellent professional, organizational, and communication skills. General office and/or administrative skills Computer skills and data entry Knowledge of medical terminology Deadline oriented Strong interpersonal Skills
Environmental Exposure:
Possible exposure to bloodborne pathogens. Possible exposure to chemical and electrical hazards.
NextStage Clinical Research Values and Culture:
As a team member of NextStage Clinical Research, you are expected to demonstrate behaviors that reflect our Values and Culture and act in ways that promote the best interest of our patients, physicians, and customers entrusted to our care.
Position Responsibilities:
1. Patient Recruitment and Enrolment: Identifying and screening potential study participants according to study eligibility criteria. Facilitating the informed consent process, explaining study details, benefits, and risks to potential participants, and managing participant enrollment.
2. Data Collection and Management: Collecting, recording, and managing research data accurately and efficiently. This may involve gathering information from medical records, conducting interviews or questionnaires with study participants, performing physical examinations, and maintaining study databases or electronic data capture systems.
3. Study Visits and Procedures: Coordinating and conducting study visits and procedures, ensuring that all required assessments, tests, and interventions are carried out according to the study protocol. This includes administering study drugs or interventions, collecting samples (e.g., blood, urine) for testing, and ensuring participant safety during all study procedures.
4. Regulatory Compliance: Ensuring compliance with all applicable regulatory and ethical guidelines, including Good Clinical Practice (GCP) standards, local regulations, and Institutional Review Board (IRB)/Ethics Committee requirements. This involves obtaining necessary approvals, maintaining study documentation, and facilitating regulatory inspections or audits.
5. Participant Monitoring and Safety: Monitoring and assessing participant safety throughout the study. This may include managing adverse events or side effects, providing education and support to participants, and promptly reporting any safety concerns to the study team and regulatory authorities.
6. Collaboration and Communication: Collaborating with the research team, investigators, study sponsors, and other stakeholders to ensure effective communication and coordination. This involves participating in study team meetings, providing updates on study progress, and resolving any issues or challenges that arise during the course of the study.
7. Quality Control and Documentation: Maintaining accurate and complete study documentation, including case report forms, source documents, and regulatory files. Performing quality control checks to ensure data accuracy and adherence to protocol requirements.
8. Education and Training: Providing education and training to study participants, healthcare providers, and research staff on study protocols, procedures, and regulatory requirements. This includes conducting study-specific training sessions, providing ongoing support and guidance, and ensuring staff competency in all aspects of the research study.
Overall, a Clinical Research Coordinator is responsible for coordinating and supporting the day-to-day operations of clinical research studies, ensuring adherence to regulatory requirements and ethical standards, and contributing to the generation of high-quality research evidence. This role requires strong organizational and communication skills, attention to detail, and the ability to work effectively within a multidisciplinary team.
A Clinical Research Coordinator (CRC) plays a pivotal role in the successful implementation and management of clinical research studies. This role involves coordinating and overseeing all aspects of research studies, including patient recruitment, data collection, documentation, and compliance with regulatory and ethical guidelines.
Education: Bachelor's degree and/or license such as C-MA or LPN; One to two years experience working in a Research Assistant or CRC role or related industry role; OR an equivalent combination of the above education and experience Knowledge of medical terminology Strong team player with interpersonal skills Must be able to work in a high paced environment Exceptional organizational and time management skills, ability to prioritize tasks - detailed oriented Computer skills (familiar with electronic health record systems, Microsoft Office) Physical Demands:
Requires extensive mobility: walking, standing, bending, stooping, kneeling, crouching, or crawling. Ability to sit for long periods of time. Pushing, pulling, and lifting of equipment. Requires mental alertness and accuracy for decision making. Requires ability to speak and hear. Repetitive motion required for extensive use of computers. Good visual acuity. Ability to lift up to 50 pounds.
Mental Demands:
Requires English language skills for constant high-level written and interpersonal communications. Ability to work well with patients, sponsors, physicians, NCR Team Members, and representatives from other healthcare organizations. Must be able to multitask and to work independently with minimal supervision. Excellent professional, organizational, and communication skills. General office and/or administrative skills Computer skills and data entry Knowledge of medical terminology Deadline oriented Strong interpersonal Skills
Environmental Exposure:
Possible exposure to bloodborne pathogens. Possible exposure to chemical and electrical hazards.
NextStage Clinical Research Values and Culture:
As a team member of NextStage Clinical Research, you are expected to demonstrate behaviors that reflect our Values and Culture and act in ways that promote the best interest of our patients, physicians, and customers entrusted to our care.
Position Responsibilities:
1. Patient Recruitment and Enrolment: Identifying and screening potential study participants according to study eligibility criteria. Facilitating the informed consent process, explaining study details, benefits, and risks to potential participants, and managing participant enrollment.
2. Data Collection and Management: Collecting, recording, and managing research data accurately and efficiently. This may involve gathering information from medical records, conducting interviews or questionnaires with study participants, performing physical examinations, and maintaining study databases or electronic data capture systems.
3. Study Visits and Procedures: Coordinating and conducting study visits and procedures, ensuring that all required assessments, tests, and interventions are carried out according to the study protocol. This includes administering study drugs or interventions, collecting samples (e.g., blood, urine) for testing, and ensuring participant safety during all study procedures.
4. Regulatory Compliance: Ensuring compliance with all applicable regulatory and ethical guidelines, including Good Clinical Practice (GCP) standards, local regulations, and Institutional Review Board (IRB)/Ethics Committee requirements. This involves obtaining necessary approvals, maintaining study documentation, and facilitating regulatory inspections or audits.
5. Participant Monitoring and Safety: Monitoring and assessing participant safety throughout the study. This may include managing adverse events or side effects, providing education and support to participants, and promptly reporting any safety concerns to the study team and regulatory authorities.
6. Collaboration and Communication: Collaborating with the research team, investigators, study sponsors, and other stakeholders to ensure effective communication and coordination. This involves participating in study team meetings, providing updates on study progress, and resolving any issues or challenges that arise during the course of the study.
7. Quality Control and Documentation: Maintaining accurate and complete study documentation, including case report forms, source documents, and regulatory files. Performing quality control checks to ensure data accuracy and adherence to protocol requirements.
8. Education and Training: Providing education and training to study participants, healthcare providers, and research staff on study protocols, procedures, and regulatory requirements. This includes conducting study-specific training sessions, providing ongoing support and guidance, and ensuring staff competency in all aspects of the research study.
Overall, a Clinical Research Coordinator is responsible for coordinating and supporting the day-to-day operations of clinical research studies, ensuring adherence to regulatory requirements and ethical standards, and contributing to the generation of high-quality research evidence. This role requires strong organizational and communication skills, attention to detail, and the ability to work effectively within a multidisciplinary team.