Clinical Project Coordinator

Imaging Endpoints; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

A leading imaging technology firm based in Hyderabad seeks a Clinical Project Coordinator. This role involves managing site evaluations, coordinating trainings, and ensuring compliance with clinical trial standards. Ideal candidates will have clinical trial experience, knowledge of Good Clinical Practice, and strong organizational skills. Join a passionate team to advance imaging science and technology in oncology.

Qualifications

• Experience in clinical trials is preferred.
• Prior experience as Clinical Research Coordinators (CRC) preferred.
• Knowledge of QA/Compliance in clinical trials setting is preferred.

Responsibilities

• Evaluate sites for capability to participate in imaging trials.
• Coordinate site trainings and maintain the Project Tracker.
• Document discrepancies and ensure project documents are complete.

Skills

Proficiency in MS Office

Attention to detail

Excellent communication skills

Service-oriented approach

Organizational skills

Ability to work independently

Ability to manage project activities

Ability to prioritize workload

Education

Experience in the medical or clinical trials industry

Knowledge of Good Clinical Practice (GCP)

Job description

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. 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.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. 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.

CLINICAL PROJECT COORDINATOR

RESPONSIBILITIES

Following standard operating procedures evaluate sites for capability to participate in the imaging in assigned trials

Escalate site evaluation issues to Project Manager (PM)

Schedule and coordinate site trainings

Primary contact for clinical trial site activities

Maintaining Project Tracker

• Trial Master File (TMF) owner

Maintain TMF and ensure project documents are complete, current, and stored appropriately according to SOPs

Document the discrepancies are remediation plans and instruct appropriate department on the correction required

• Audit preparation and readiness activities

Provide study documents for audit to the study compliance team member as required

Verify all processes and procedures to maintain compliant standards of the study

• Verification of PM activities for study and read start up

Provide direction on compliance per company SOPs on to study readiness for the appropriate stage of the clinical trial

Direct PM on remediation of outstanding issues

• 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
• Tracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicable
• 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; generate weekly status, site, and enrollment reports
• 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
• Maintain confidentiality and adhere to HIPAA regulations
• Perform other duties as assigned by supervisor

EDUCATION AND EXPERIENCE

• 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

RESPONSIBILITIES

• Coordinate & collaborate with PMs for the site list, updating the site contact details and granting relevant system access (AG Mednet, CTMS)

Following Standard operating procedures evaluate sites for capability to participate in the imaging in assigned trials

Escalate site evaluation issues to Project Manager (PM)

Schedule and coordinate site trainings

Act as primary contact for clinical trial site activities

• Trial Master File (TMF) owner

Maintain TMF and ensure project documents are complete, current, and stored appropriately according to SOPs

Document the discrepancies and remediation plans and instruct appropriate department on the correction required

• Responsible for audit readiness of assigned trials

Provide study documents for audit to Study Compliance member as needed

Verify all processes and procedures to maintain compliant standards of the study

• Verification of PM activities for study and read start up

Provide direction on compliance per company SOPs on to study readiness for the appropriate stage of the clinical trial

Direct PM on remediation of outstanding issues

• Training and mentoring

Train the new CPCs on the CPC tasks and mentor them as they are assigned to

• Study Closeout activities

Complete all tasks related to the study closeout by coordinating with the project team

and update PM regularly

Ensure alignment of closeout timelines and communicate effectively through the duration of the closeout activity for the trial

• 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
• Tracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicable
• 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; generate weekly status, site, and enrollment reports
• 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
• Maintain confidentiality and adhere to HIPAA regulations
• Perform other duties as assigned by supervisor

EDUCATION AND EXPERIENCE

• 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

SKILLS

• 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 superior attention to detail including excellent oral and written communication skills
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• 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
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self‑motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day‑to‑day business
• Ability to understand technical research protocols and successfully lead within the research environment
• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong 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 https://imagingendpoints.com/caring-endpoints/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self‑motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else