Learn about Radiance career opportunities
Below are our current job openings at Radiance Clinical Research. You can click on the job below to learn more and apply if it looks like a good fit, or you can submit your resume to be considered for future openings.
Health Insurance
Dental Insurance
401K
Retirement
Paid
Time Off
Available Positions
CLINICAL RESEARCH COORDINATOR
Role Summary
The Clinical Research Coordinator (CRC) is a specialized research professional working with
and under the direction of the Principal Investigator (PI). While the Principal Investigator is
primarily responsible for the overall conduct, and management of the clinical trial, the CRC
supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in
the conduct of the study. By performing these duties, the CRC works with the PI, the CRO, the
Sponsor, the monitor, and Radiance department staff, to conduct the clinical study in a quality
and compliant manner.
During the conduct of a clinical study, the clinical research coordinator reports primarily to the
Principal Investigator with associated responsibilities to the RADIANCE clinical study team.
Responsibilities
Ensuring the study conduct is compliant with applicable local and federal laws and
regulations.
Assists the PI in development of materials and tools necessary to appropriately train the
RADIANCE project team in the conduct of the study.
Assists Principal Investigator to assure that all RADIANCE project team members have
met all training requirements in accordance with regard to the investigational plan (e.g.,
protocol), applicable Federal regulations, internationally harmonized standards (e.g., Good
Clinical Practice), and RADIANCE policies and procedures.
Cooperates with RADIANCE staff and leadership to report and address instances of
noncompliance and/or nonconformity.
Coordinates and facilitates monitoring and auditing visits.
Notifies RADIANCE staff and leadership of external audits by FDA and Sponsors.
Collaborates with PI, RADIANCE staff and leadership to respond to audit findings and to
implement approved recommendations.
Collects documents needed to initiate a clinical study and submit to the sponsor (e.g., FDA
Forms 1572, CVs, etc.).
Coordinates and conducts clinical study subject visits for the completion of protocol-
specified study tests, assessments, and the collection/processing of requisite biological
laboratory specimens.
Collects all clinical study data as required by the protocol.
Assures timely completion of Case Report Forms, source documents, and/or entry into
electronic repositories/databases.
Maintains study timelines.
Maintains adequate inventory of clinical study supplies.
Handles, manages and maintains investigational products (IP) in compliance with the
clinical study protocol, applicable clinical study/pharmacy plans, Sponsor/CRO directives
and/or RADIANCE IP Drug/Device accountability policies.
Completes study documentation and maintains study files in accordance with protocol
requirements, CRO/Sponsor requirements and RADIANCE policies and procedures
including, but not limited to, consent forms, source documentation, subject narrative, case
report forms, adverse event documentation, and IP accountability forms.
Retains all study records in accordance with applicable regulatory requirements, sponsor
requirements and RADIANCE policies and procedures.
Maintains effective and ongoing communication with clinical study Sponsor, CRO,
Monitor, PI, and study subjects during the course of the study.
Works with the PI and RADIANCE study team to manage the day to day activities of the
study including problem solving, communication and protocol management.
Collaborates with the PI and Regulatory Department to prepare IRB and any other
regulatory submission documents as required by the investigational plan (Protocol).
Acts as a point of reference for clinical study subjects by answering questions and keeping
them informed on the study progress.
Manages and maintains an effective inventory of equipment and supplies needed for
uninterrupted conduct of the clinical study.
Qualifications
General
Excellent written and verbal communication skills
Superior organizational and time management skills
Capable of working independently with minimal supervision and also as part of a team
Skilled with standard computer programs including the MS Office suite
Participate with staff, managers and/or corporate leadership in the creation and
implementation of processes and procedures toward quality improvement initiatives
CRC Assistant
Schedule patient visits, including testing to be performed at vendor facilities (e.g., imaging,
eye exams, etc.)
Assist with the preparation for patient visits
Assist CRCs with source data entry completion and query resolution
Assist with the request and receipt of outside medical records and test results
Assist with chart management (e.g., record scanning, labeling filing, etc.)
Locate and file laboratory requisitions and laboratory reports
Pull charts for laboratory reports and route to PI for review and signature
Receive and transport patient laboratory samples from Georgetown facility
Assist with the preparation for study closeout visits
Departmental printing and document management support
CRC Level I
1+ years previous experience working in a clinical setting. A combination of education and
related technical/paraprofessional experience may be an acceptable alternative.
Motivated to learn and assume responsibility for advanced clinical research and associated
supportive activities.
Ability to effectively assist, under supervision of the assigned CRC, in the management
and conduct of multiple projects.
CRC Level II
Bachelor's degree, Allied Health or related professional degree, and/or equivalent work
experience.
1-2 years of clinical research and/or related experience.
Experience as a clinical research coordinator and/or in the clinical research field is
preferred.
Understanding of Good Clinical Practice as established in International Council for
Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical
Practice E6(R2).
Accurately generate, collect and record research data in clinical study source documents
and/or electronic databases such as Clinical Trial Management Systems (CTMS),
Electronic Data Capture Systems (EDC).
Conduct clinical study subject visits/interactions in a professional manner, and to
effectively inform prospective subjects of study details through phone contact and/or
personal interview.
Ability to independently lead, manage multiple clinical study projects simultaneously and
to communicate reasonable expectations regarding workflow, deadlines and deliverables.
CRC Level III
Bachelor's degree, Allied Health or related professional degree, and/or equivalent work
experience.
1-2 years of Clinical Research Coordinator experience.
Understanding of Good Clinical Practice as established in International Council for
Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical
Practice E6(R2).
PATIENT RECRUITMENT SPECIALIST
Primary objective: identify potential patients for clinical trial screening and schedule screening
appointments. Recruitment expectations include 80 phone calls per day or 25 potential subject
conversations, resulting in a minimum of 6 new patient appointments each day a provider is in the office.
Marketing will be planned around recruitment needs and will be done after recruitment goals are met, or in cases when potential patient pools are exhausted, prior to goals being met.
Marketing plans and reports will be submitted to management with cost reports.
Advertising management will be done with site director and marketing firm. Plan for each
protocol should be developed with site director and marketing firm and approved by COO and
site director. Responsible for maintaining summary of efforts for each study and ordering of marketing materials.
DAILY RESPONSIBILITIES
RECRUITER
Check the day’s schedule for cancellations and call patients on wait list to fill holes
Recruitment calls (goal of 80 calls per day or 25 conversations; goal of 20 new patient appointments per week)
Maintain recruitment rosters in RealTime CTMS with goal of all potential subjects contacted
by end of business each day and all leads contacted within the last 2 business days
Schedule new patient appointments and keep GoogleDoc schedule up to date on daily basis to utilize all slots efficiently
Assess subject eligibility for clinical trials utilizing generic phone screen and study eligibility
criteria and tip sheets, or IRB approved study specific phone script; document all efforts on
phone screen forms
Document all phone calls in RealTime CTMS and on recruitment spreadsheet; prepare weekly recruitment metrics for all staff
Act as a point of contact and build confidence with potential patients
Answer phone calls and re-route as appropriate
Serve as back up to reception/ front desk (check-in patients)
REQUIREMENTS
Proven work experience as a recruiter
Solid ability to conduct different types of interviews (structured, competency based, stress etc)
Excellent communication and interpersonal skills
Strong decision-making skills
Research Assistant
Role Summary
The Clinical Research Coordinator (CRC) is a specialized research professional working with
and under the direction of the Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall conduct, and management of the clinical trial, the CRC
supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, the CRO, the Sponsor, the monitor, and Radiance department staff, to conduct the clinical study in a quality
and compliant manner.
During the conduct of a clinical study, the clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the RADIANCE clinical study team.
Responsibilities
Ensuring the study conduct is compliant with applicable local and federal laws and
regulations.
Assists the PI in development of materials and tools necessary to appropriately train the
RADIANCE project team in the conduct of the study.
Assists Principal Investigator to assure that all RADIANCE project team members have met all training requirements in accordance with regard to the investigational plan (e.g.,
protocol), applicable Federal regulations, internationally harmonized standards (e.g., Good Clinical Practice), and RADIANCE policies and procedures.
Cooperates with RADIANCE staff and leadership to report and address instances of
noncompliance and/or nonconformity.
Coordinates and facilitates monitoring and auditing visits.
Notifies RADIANCE staff and leadership of external audits by FDA and Sponsors.
Collaborates with PI, RADIANCE staff and leadership to respond to audit findings and to implement approved recommendations.
Collects documents needed to initiate a clinical study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
Coordinates and conducts clinical study subject visits for the completion of protocol-
specified study tests, assessments, and the collection/processing of requisite biological
laboratory specimens.
Collects all clinical study data as required by the protocol.
Assures timely completion of Case Report Forms, source documents, and/or entry into
electronic repositories/databases.
Maintains study timelines.
Maintains adequate inventory of clinical study supplies.
Handles, manages and maintains investigational products (IP) in compliance with the clinical study protocol, applicable clinical study/pharmacy plans, Sponsor/CRO directives
and/or RADIANCE IP Drug/Device accountability policies.
Completes study documentation and maintains study files in accordance with protocol requirements, CRO/Sponsor requirements and RADIANCE policies and procedures including, but not limited to, consent forms, source documentation, subject narrative, case report forms, adverse event documentation, and IP accountability forms.
Retains all study records in accordance with applicable regulatory requirements, sponsor requirements and RADIANCE policies and procedures.
Maintains effective and ongoing communication with clinical study Sponsor, CRO,
Monitor, PI, and study subjects during the course of the study.
Works with the PI and RADIANCE study team to manage the day to day activities of the study including problem solving, communication and protocol management.
Collaborates with the PI and Regulatory Department to prepare IRB and any other
regulatory submission documents as required by the investigational plan (Protocol).
Acts as a point of reference for clinical study subjects by answering questions and keeping them informed on the study progress.
Manages and maintains an effective inventory of equipment and supplies needed for uninterrupted conduct of the clinical study.
Qualifications
General
Excellent written and verbal communication skills
Superior organizational and time management skills
Capable of working independently with minimal supervision and also as part of a team
Skilled with standard computer programs including the MS Office suite
Participate with staff, managers and/or corporate leadership in the creation and
implementation of processes and procedures toward quality improvement initiatives
CRC Assistant
Schedule patient visits, including testing to be performed at vendor facilities (e.g., imaging, eye exams, etc.)
Assist with the preparation for patient visits
Assist CRCs with source data entry completion and query resolution
Assist with the request and receipt of outside medical records and test results
Assist with chart management (e.g., record scanning, labeling filing, etc.)
Locate and file laboratory requisitions and laboratory reports
Pull charts for laboratory reports and route to PI for review and signature
Receive and transport patient laboratory samples from Georgetown facility
Assist with the preparation for study closeout visits
Departmental printing and document management support
CRC Level I
1+ years previous experience working in a clinical setting. A combination of education and related technical/paraprofessional experience may be an acceptable alternative.
Motivated to learn and assume responsibility for advanced clinical research and associated supportive activities.
Ability to effectively assist, under supervision of the assigned CRC, in the management and conduct of multiple projects.
CRC Level II
Bachelor's degree, Allied Health or related professional degree, and/or equivalent work experience.
1-2 years of clinical research and/or related experience.
Experience as a clinical research coordinator and/or in the clinical research field is
preferred.
Understanding of Good Clinical Practice as established in International Council for
Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).
Accurately generate, collect and record research data in clinical study source documents and/or electronic databases such as Clinical Trial Management Systems (CTMS),
Electronic Data Capture Systems (EDC).
Conduct clinical study subject visits/interactions in a professional manner, and to
effectively inform prospective subjects of study details through phone contact and/or
personal interview.
Ability to independently lead, manage multiple clinical study projects simultaneously and to communicate reasonable expectations regarding workflow, deadlines and deliverables.
CRC Level III
Bachelor's degree, Allied Health or related professional degree, and/or equivalent work experience.
1-2 years of Clinical Research Coordinator experience.
Understanding of Good Clinical Practice as established in International Council for
Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).
Accurately generate, collect and record research data in clinical study source documents and/or electronic databases such as Clinical Trial Management Systems (CTMS),
Electronic Data Capture Systems (EDC).
Conduct clinical study subject visits/interactions in a professional manner, and to
effectively inform prospective subjects of study details through phone contact and/or
personal interview.
Ability to independently lead, manage multiple projects simultaneously and to
communicate reasonable expectations regarding workflow, deadlines and deliverables.
Ability to mentor, advise and/or assist other CRCs in the conduct of their assigned
projects.
Prior experience training and mentoring staff members is preferred
Lead CRC
3+ years of Clinical Research Coordinator experience.
Understanding of Good Clinical Practice as established in International Council for
Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
Accurately generate, collect and record research data in clinical study source documents and/or electronic databases such as Clinical Trial Management Systems (CTMS),
Electronic Data Capture Systems (EDC).
Conduct clinical study subject visits/interactions in a professional manner, and to
effectively inform prospective subjects of study details through phone contact and/or
personal interview.
Prior experience training and mentoring staff members
Supervisory experience
Assign projects to research staff and prioritize their conduct/completion.
Provide leadership, guidance, mentoring and oversight to research staff in the execution of their assigned tasks.
Experience with Clinical Trial Management Systems (CTMS)
Certification as a Certified Clinical Research Coordinator (CCRC) through the
Association of Clinical Research Professionals (ACRP) or as a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates
(SoCRA) desirable.