Diagnamics, Inc.
Co-Founder & Clinical Research Site Director at Diagnamics | Site Management, Strategy, Research Operations
Diagnamics is seeking a full-time, on-site Clinical Research Coordinator (CRC) to manage the day-to-day operations of various research studies. Primary responsibilities include obtaining informed consent, leading recruitment efforts, coordinating patient visits, performing blood draws and other clinical assessments, maintaining study documentation, ensuring protocol and regulatory compliance, and collaborating with investigators, site staff, and study sponsors.
Required Qualifications
Bachelor’s degree or equivalent experience in a related field (i.e. life sciences, healthcare, etc.)
At least one (1) year of experience in a clinical research and/or healthcare setting; Preference given to those with direct patient care experience (i.e. research coordinator, phlebotomist, medical assistant, nursing assistant, etc.)
Demonstrated ability to organize and prioritize a complex and dynamic workload
Critical thinker and problem solver with proven ability to take initiative and follow through on assignments with minimal supervision
Ability to exercise discretion and sound judgment; High level of integrity and honesty in maintaining confidentiality
Strong written and verbal communication skills; Ability to interact in a professional, resourceful, and courteous manner
Must live within commutable distance to Encinitas, California. Relocation assistance is not available for this position.
Preferred Qualifications
Phlebotomy certification or recent experience independently performing blood draws
Working knowledge of medical terminology, clinical research concepts and practices, and relevant policies and regulatory requirements (ICH, FDA, GCP)
Key Responsibilities
Support research efforts by providing comprehensive coordination for various Phase I-IV clinical trials in accordance with established research protocols and standard operating procedures (SOPs)
Perform all duties in compliance with applicable laws, regulations, policies, and procedural requirements (FDA, ICH, GCP, HIPAA, IRB, IATA, etc.)
Execute protocol-specified patient visits and procedures, which may include, but not limited to, vital signs, phlebotomy, injections, spirometry, ECG/EKG, etc.
Handle, process, and prepare biological samples for shipment
Ethically recruit qualified subjects to meet enrollment timelines; Create and disseminate study materials and advertisements for local recruitment campaigns
Conduct all screening activities for assigned protocols, including assessing patient eligibility, educating patients on non-medical trial concepts and details; Assist investigator in the informed consent process
Ensure good documentation practices are applied when collecting, maintaining and correcting study data and required records, including source documentation, case report forms, queries, drug dispensation records, regulatory forms, etc.
Maintain accountability for all investigational products, specimens, and labs kits; Monitor inventory levels and order study-related supplies as needed
Ensure protocol compliance by understanding study timelines and prioritizing tasks based on visit windows and protocol-specific schedule of activities
Schedule and participate in monitoring activities; Prepare for internal/external audits by maintaining and regularly reviewing site regulatory files
Interface directly with local/central Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with local and federal guidelines
Collaborate with investigators, sponsors, monitors, and internal team members to support high quality study conduct
Complete required/ongoing training; attend investigator meetings/courses; stay current with changing regulations and Diagnamics policies
Help maintain social media accounts, including Facebook, Instagram, and LinkedIn
Additional duties as assigned
Pay Range:
$26.50 - $32.00 per hour
Position Type:
Full-time; 35 - 40 hours per week
Shift Schedule:
Monday - Friday; 9:00 AM - 5:00 PM
Work Location:
On-site in Encinitas, CA *Must be able to commute to the office daily; Remote work and relocation assistance are NOT offered*
Benefits
401(k) and 401(k) Matching
Health Insurance
Paid Time Off
Retirement Plan
#J-18808-Ljbffr
Required Qualifications
Bachelor’s degree or equivalent experience in a related field (i.e. life sciences, healthcare, etc.)
At least one (1) year of experience in a clinical research and/or healthcare setting; Preference given to those with direct patient care experience (i.e. research coordinator, phlebotomist, medical assistant, nursing assistant, etc.)
Demonstrated ability to organize and prioritize a complex and dynamic workload
Critical thinker and problem solver with proven ability to take initiative and follow through on assignments with minimal supervision
Ability to exercise discretion and sound judgment; High level of integrity and honesty in maintaining confidentiality
Strong written and verbal communication skills; Ability to interact in a professional, resourceful, and courteous manner
Must live within commutable distance to Encinitas, California. Relocation assistance is not available for this position.
Preferred Qualifications
Phlebotomy certification or recent experience independently performing blood draws
Working knowledge of medical terminology, clinical research concepts and practices, and relevant policies and regulatory requirements (ICH, FDA, GCP)
Key Responsibilities
Support research efforts by providing comprehensive coordination for various Phase I-IV clinical trials in accordance with established research protocols and standard operating procedures (SOPs)
Perform all duties in compliance with applicable laws, regulations, policies, and procedural requirements (FDA, ICH, GCP, HIPAA, IRB, IATA, etc.)
Execute protocol-specified patient visits and procedures, which may include, but not limited to, vital signs, phlebotomy, injections, spirometry, ECG/EKG, etc.
Handle, process, and prepare biological samples for shipment
Ethically recruit qualified subjects to meet enrollment timelines; Create and disseminate study materials and advertisements for local recruitment campaigns
Conduct all screening activities for assigned protocols, including assessing patient eligibility, educating patients on non-medical trial concepts and details; Assist investigator in the informed consent process
Ensure good documentation practices are applied when collecting, maintaining and correcting study data and required records, including source documentation, case report forms, queries, drug dispensation records, regulatory forms, etc.
Maintain accountability for all investigational products, specimens, and labs kits; Monitor inventory levels and order study-related supplies as needed
Ensure protocol compliance by understanding study timelines and prioritizing tasks based on visit windows and protocol-specific schedule of activities
Schedule and participate in monitoring activities; Prepare for internal/external audits by maintaining and regularly reviewing site regulatory files
Interface directly with local/central Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with local and federal guidelines
Collaborate with investigators, sponsors, monitors, and internal team members to support high quality study conduct
Complete required/ongoing training; attend investigator meetings/courses; stay current with changing regulations and Diagnamics policies
Help maintain social media accounts, including Facebook, Instagram, and LinkedIn
Additional duties as assigned
Pay Range:
$26.50 - $32.00 per hour
Position Type:
Full-time; 35 - 40 hours per week
Shift Schedule:
Monday - Friday; 9:00 AM - 5:00 PM
Work Location:
On-site in Encinitas, CA *Must be able to commute to the office daily; Remote work and relocation assistance are NOT offered*
Benefits
401(k) and 401(k) Matching
Health Insurance
Paid Time Off
Retirement Plan
#J-18808-Ljbffr