Senior Clinical Research Coordinator - ICONMA, LLC
Malden, MA 02148
About the Job
Senior Clinical Research Coordinator
Location: Malden, MA
Duration: 12 Months With possible Extension/With possible Contract to hire
Description:
Summary:
The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials. Working in collaboration with the Principal Investigator, the Sr. CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.
The Sr. CRC works collaboratively with the entire team, sponsors, and Clinical Quality Associates to ensure productivity, quality, and timely completion of studies.
The Sr. CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities.
The Sr. CRC applies critical thinking and creative problem-solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards.
Job Responsibilities:
Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants)
Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol
Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations
Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial
Function as participants’ primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events)
Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator
Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Client databases
Supports the regulatory staff in the maintenance of regulatory documents in accordance with Client SOPs and applicable regulations
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Maintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrollment)
Maintain study supplies and issue appropriate participant stipends
Ensures appropriate credentialing and training of the study team
Facilitate meetings with the study monitors, auditors, and investigators
Ensure timely response to queries and documentation of study-related issues
If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary
Contribute to the development and implementation of tools, processes and training to enhance the administration and execution of clinical studies (e.g., GCP, ALCOA-C)
Accountable for site compliance with subject safety reporting, escalate issues
Demonstrate professionalism and apply basic leadership practices in all aspects of the role
Train and support study team members on a range of communication and teamwork best practices
Performs other duties related to the clinical trials as delegated by the Principal Investigator
Seeking a seasoned Senior Clinical Research Coordinator (SCRC) to join our the Delivery Operations Team.
Responsibilities include:
Conducting all trial visits
Completing all study-specific assessments (e.g. vital signs, EKG, blood collection)
Processing all samples and shipping to Central Lab
Maintaining study source
Entering data into sponsor EDC and query resolution As the sole Senior Clinical Research Coordinator (SCRC) on-site, the chosen candidate must be adept at protocol comprehension and be capable of working autonomously.
Experience :
3-5 years in clinical trial space
Education: BA Skills required:
Proficiency in ICH-GCP, US CFR, and HIPAA regulations
Demonstrated ability to work independently, make informed decisions, and drive clinical trials forward
Track record of managing multiple clinical trials simultaneously with meticulous attention to detail
Strong prioritization skills, adept at meeting deadlines, and flexible in adapting to shifting priorities
Proficiency in phlebotomy (certification not mandatory)
Preferred qualifications:
Experience with decentralized/hybrid clinical trials
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Location: Malden, MA
Duration: 12 Months With possible Extension/With possible Contract to hire
Description:
Summary:
The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials. Working in collaboration with the Principal Investigator, the Sr. CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.
The Sr. CRC works collaboratively with the entire team, sponsors, and Clinical Quality Associates to ensure productivity, quality, and timely completion of studies.
The Sr. CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities.
The Sr. CRC applies critical thinking and creative problem-solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards.
Job Responsibilities:
Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants)
Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol
Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations
Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial
Function as participants’ primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events)
Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator
Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Client databases
Supports the regulatory staff in the maintenance of regulatory documents in accordance with Client SOPs and applicable regulations
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Maintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrollment)
Maintain study supplies and issue appropriate participant stipends
Ensures appropriate credentialing and training of the study team
Facilitate meetings with the study monitors, auditors, and investigators
Ensure timely response to queries and documentation of study-related issues
If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary
Contribute to the development and implementation of tools, processes and training to enhance the administration and execution of clinical studies (e.g., GCP, ALCOA-C)
Accountable for site compliance with subject safety reporting, escalate issues
Demonstrate professionalism and apply basic leadership practices in all aspects of the role
Train and support study team members on a range of communication and teamwork best practices
Performs other duties related to the clinical trials as delegated by the Principal Investigator
Seeking a seasoned Senior Clinical Research Coordinator (SCRC) to join our the Delivery Operations Team.
Responsibilities include:
Conducting all trial visits
Completing all study-specific assessments (e.g. vital signs, EKG, blood collection)
Processing all samples and shipping to Central Lab
Maintaining study source
Entering data into sponsor EDC and query resolution As the sole Senior Clinical Research Coordinator (SCRC) on-site, the chosen candidate must be adept at protocol comprehension and be capable of working autonomously.
Experience :
3-5 years in clinical trial space
Education: BA Skills required:
Proficiency in ICH-GCP, US CFR, and HIPAA regulations
Demonstrated ability to work independently, make informed decisions, and drive clinical trials forward
Track record of managing multiple clinical trials simultaneously with meticulous attention to detail
Strong prioritization skills, adept at meeting deadlines, and flexible in adapting to shifting priorities
Proficiency in phlebotomy (certification not mandatory)
Preferred qualifications:
Experience with decentralized/hybrid clinical trials
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Source : ICONMA, LLC
