30 Jul
|
Imaging Endpoints
|
Telangana
30 Jul
Imaging Endpoints
Telangana
SUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.
We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.
Under the direction of Imaging Operations Management this position is responsible to work with the Operations staff, Sponsor staff, and study sites in coordinating clinical project activities. The Clinical Project Coordinator / Clinical Project Coordinator II / Lead Clinical Project Coordinator requires skill similar to a Clinical Research Coordinator (CRC) but does not have direct patient interaction.
CLINICAL PROJECT COORDINATOR
Escalate site evaluation issues to Project Manager (PM)
Primary contact for clinical trial site activities
Maintaining Project Tracker
~ Maintain TMF and ensure project documents are complete, current, and stored appropriately according to SOPs
Provide direction on compliance per company SOPs on to study readiness for the appropriate stage of the clinical trial
Assist PM with other project start-up activities and throughout the life cycle of the project
Ensure timely updates to project tracker, including study enrollment
Perform User Acceptance Testing as assigned by supervisor
Provide pre-processing help for CTIS tasks, such as DTF downloads to the study repository
Track, data-enter, and manage Case Report Forms (CRFs), queries, and clinical data flow
Convert clinical dossiers for reader assignments per SSPs
Report on project status to client and management; Contact sites for query and data follow up
Schedule project meetings, generate agendas and document meeting minutes
Understand and comply with protocol guidelines and requirements of regulatory agencies
Perform other duties as assigned by supervisor
EDUCATION AND EXPERIENCE
Bachelor's degree required
Experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)
Prior experience as Clinical Research Coordinators (CRC) would be preferred for this position
Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
Has strong organizational and time management skills
Proficiency in MS Office and internet applications required
CLINICAL PROJECT COORDINATOR II
Escalate site evaluation issues to Project Manager (PM)
Act as primary contact for clinical trial site activities
~ Maintain TMF and ensure project documents are complete, current, and stored
appropriate stage of the clinical trial
Training and mentoring
Train the new CPCs on the CPC tasks and mentor them as they are assigned to
Complete all tasks related to the study closeout by coordinating with the project team
Effectively communicate all clinical project related information including the planning and execution of study-related meetings and presentations
Assist PM with other project start-up activities and throughout the life cycle of the project
Ensure timely updates to project tracker, including study enrollment
Perform User Acceptance Testing and Image Reconciliation as assigned by supervisor
Provide pre-processing help for CTIS tasks, such as DTF downloads to the study repository
Track,
data-enter and manage Case Report Forms (CRFs), queries and clinical data flow
Convert clinical dossiers for reader assignments per SSPs
Report on project status to client and management; Contact sites for query and data follow up
Perform Image reconciliation as assigned by supervisor
Schedule project meetings, generate agendas and document meeting minutes
Understand and comply with protocol guidelines and requirements of regulatory agencies
Perform other duties as assigned by supervisor
EDUCATION AND EXPERIENCE
Bachelor's degree required
Minimum of 1 year of experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)
Prior experience as Clinical Research Coordinators (CRC) would be preferred for this position
Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
Has strong organizational and time management skills
Proficiency in MS Office and internet applications required
Proficiency in MS Office and internet applications
Service-oriented approach, flexible, and proactive toward adapting to client needs
Ability to manage project activities with diverse group and individuals with little supervision
Must have strong time management and organization skills
Self-driven, ability to get the job done with little supervision, can-do positive attitude
Ability to excel in a team environment
Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
Solid desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
we enjoy advancing clinical trials, helping patients, and celebrating success
we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
📌 Project Manager (Homebased) (Telangana)
🏢 Imaging Endpoints
📍 Telangana