Clinical Research Study Coordinator Level II
Description
JOB
Summary:
The Clinical Research Study Coordinator executes and coordinates daily clinical research activities according to GCP and FDA/ICH guidelines; completes and organizes all IRB/Sponsor regulatory documents; ensures IRB approved protocols are implemented and followed; conducts study specific training on new or amended protocols; educates patients and their families about clinical trial treatments; identifies patients for study eligibility; executes and documents the informed consent process; monitors patient status and safety; coordinates patient visits according to protocol; collects, processes and ships lab samples; collects, organizes and reports research data and resolves queries; maintains investigational product inventory and oversees the dispensing of investigational product; invoices for study related activities; participates in monitoring visits with study sponsors and regulatory agencies, and reports regularly to the Principal Investigator and Director of Clinical Research.
This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.
JOB SPECIFIC DUTIES AND
Responsibilities:
1. Under direct supervision of a physician is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.
2. Collaborates with physician in determining eligibility of patients for clinical trials.
3. Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
4. Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
5. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
6. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
7. Responsible for accurate and timely data collection, documentation, entry, query resolution and reporting. Schedules and participates in monitoring and auditing activities.
8. Maintains regulatory documents in accordance with SOPs and applicable regulations.
9. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
10. Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
11. Interacts with the Clinical Trial Sponsors to recruit new clinical trials for the site. In collaboration with the Principal Investigator, conducts feasibility questionnaires and participates in site selection process.
12. Maintain documentation of clinical trial visits and invoice for the completed site activities.
13. Order and maintain inventory of all study specific supplies including recruitment materials and specific lab kits.
14. Collect, process and ship all study defined lab kits to the Central Lab as directed by the sponsor.
Requirements
EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION:
1. Bachelor's Degree plus 2 years of general or clinical research experience OR High School diploma/GED plus 7 years of general or clinical research experience.
2. Must obtain GCP certificate in first 30 days of hire.
3. Must obtain IATA certification in first 30 days of hire.
4. CCRP or CCRC or professional certification within 6 months of exam eligibility.
5. CRA II should demonstrate experience/proficiency in the following functional areas as relevant to oncology clinical trials:
study planning/development, study coordination/management, Investigational Product accountability, regulatory documentation and data collection
EXPERIENCE, KNOWLEDGE, SKILLS and ABILITIES:
1. Two or more years of experience in clinical research or oncology preferred
2. Must be proficient with Microsoft office applications (Outlook, Word and Excel)
3. Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
4. Must have excellent communication, teamwork and problem solving skills;
5. Must be professional, possess a high degree of self-motivation and have a strong work ethic.
6. Must have the ability to adapt and take-on additional tasks as requested;
7. Must be capable of recognizing, and have the willingness, to resolve errors and issues;
8. Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.Estimated Salary: $20 to $28 per hour based on qualifications.
JOB
Summary:
The Clinical Research Study Coordinator executes and coordinates daily clinical research activities according to GCP and FDA/ICH guidelines; completes and organizes all IRB/Sponsor regulatory documents; ensures IRB approved protocols are implemented and followed; conducts study specific training on new or amended protocols; educates patients and their families about clinical trial treatments; identifies patients for study eligibility; executes and documents the informed consent process; monitors patient status and safety; coordinates patient visits according to protocol; collects, processes and ships lab samples; collects, organizes and reports research data and resolves queries; maintains investigational product inventory and oversees the dispensing of investigational product; invoices for study related activities; participates in monitoring visits with study sponsors and regulatory agencies, and reports regularly to the Principal Investigator and Director of Clinical Research.
This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.
JOB SPECIFIC DUTIES AND
Responsibilities:
1. Under direct supervision of a physician is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.
2. Collaborates with physician in determining eligibility of patients for clinical trials.
3. Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
4. Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
5. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
6. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
7. Responsible for accurate and timely data collection, documentation, entry, query resolution and reporting. Schedules and participates in monitoring and auditing activities.
8. Maintains regulatory documents in accordance with SOPs and applicable regulations.
9. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
10. Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
11. Interacts with the Clinical Trial Sponsors to recruit new clinical trials for the site. In collaboration with the Principal Investigator, conducts feasibility questionnaires and participates in site selection process.
12. Maintain documentation of clinical trial visits and invoice for the completed site activities.
13. Order and maintain inventory of all study specific supplies including recruitment materials and specific lab kits.
14. Collect, process and ship all study defined lab kits to the Central Lab as directed by the sponsor.
Requirements
EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION:
1. Bachelor's Degree plus 2 years of general or clinical research experience OR High School diploma/GED plus 7 years of general or clinical research experience.
2. Must obtain GCP certificate in first 30 days of hire.
3. Must obtain IATA certification in first 30 days of hire.
4. CCRP or CCRC or professional certification within 6 months of exam eligibility.
5. CRA II should demonstrate experience/proficiency in the following functional areas as relevant to oncology clinical trials:
study planning/development, study coordination/management, Investigational Product accountability, regulatory documentation and data collection
EXPERIENCE, KNOWLEDGE, SKILLS and ABILITIES:
1. Two or more years of experience in clinical research or oncology preferred
2. Must be proficient with Microsoft office applications (Outlook, Word and Excel)
3. Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
4. Must have excellent communication, teamwork and problem solving skills;
5. Must be professional, possess a high degree of self-motivation and have a strong work ethic.
6. Must have the ability to adapt and take-on additional tasks as requested;
7. Must be capable of recognizing, and have the willingness, to resolve errors and issues;
8. Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.Estimated Salary: $20 to $28 per hour based on qualifications.
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