50 Research Participant jobs in India

Clinical Trial Coordinator (Freshers Only)

Location: (Insert City / Across India – Hybrid/On-site)

Organization: Clinogenesis Research Organization

Department: Clinical Operations

Employment Type: Full-Time

About Clinogenesis

Clinogenesis Research Organization is a growing, innovation-driven CRO committed to excellence in clinical research and data-driven healthcare. We provide aspiring professionals with a strong foundation to build rewarding careers in the clinical research field.

About the Role

We are inviting fresh graduates who are passionate about clinical research to join us as Clinical Trial Coordinators This entry-level position offers hands-on exposure to clinical trial operations under the mentorship of experienced professionals.

Key Responsibilities

• Support the coordination and execution of clinical trial activities at the site level.
• Assist investigators in ensuring protocol adherence and accurate patient data documentation.
• Maintain and update essential study documents, logs, and case report forms.
• Ensure all research activities comply with **ICH-GCP**, regulatory, and ethical standards.
• Participate in ongoing training, team discussions, and performance reviews to enhance learning.

Eligibility Criteria

• Education: B.Pharm, M.Pharm, B.Sc / M.Sc in Life Sciences, Pharmacy, Nursing, or any equivalent healthcare discipline.
• Experience: Freshers only (candidates with prior experience will not be considered).
• Strong communication, interpersonal, and organizational abilities.
• A keen interest in building a career in the clinical research domain.

Why Join Clinogenesis?

Learn directly from experienced mentors and clinical research experts.

Gain practical exposure in a globally recognized research environment.

Continuous learning and structured professional development programs.

Clear growth pathways and opportunities for long-term career advancement.

Role : Clinical Trial Manager

Location : Chennai, Tamil Nadu

Experience : 10-15 Years

Requirements:

• 10–12 years of direct, hands-on experience in clinical trials, with a focus on interventional studies (Phase I–IV).
• Proven ability to read, interpret, and operationalize clinical trial protocols into eSource/EDC workflows.
• Experience managing end-to-end clinical trial processes including start-up, site initiation, data collection, query management, and close-out.
• Minimum 4–5 years of people management experience with demonstrated success mentoring and leading CDM/clinical trial teams.
• Strong expertise in clinical trial systems – CTMS (CRIO preferred), eSource, and EDC platforms.
• Background in pharmaceutical, biotechnology, or CRO environments across multiple therapeutic areas.
• Thorough understanding of regulatory requirements (ICH-GCP, FDA, EMA, HIPAA).
• Experience with system validation, change control, and audit/inspection readiness.

• Develop and manage clinical trial protocols, budgets, and timelines.
• Oversee the selection, initiation, and monitoring of clinical trial sites.
• Ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Manage relationships with investigators, site staff, and vendors.
• Monitor trial progress, data quality, and participant safety.
• Facilitate the collection, review, and analysis of clinical data.
• Prepare trial-related documentation, including Investigator Brochures and Case Report Forms.
• Coordinate study close-out activities.
• Liaise with regulatory authorities as needed.
• Contribute to the development of clinical development strategies.

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Minimum of 5-7 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of GCP, ICH guidelines, and regulatory submission processes.
• Proven experience in developing and executing clinical trial protocols.
• Strong project management skills with experience in budget and timeline management.
• Excellent communication, leadership, and interpersonal skills.
• Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required.
• Problem-solving skills and ability to navigate complex regulatory environments.

SUMMARY

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 Cure™. 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 (SMIURadPartners), 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 for conducting a variety of QC/analysis procedures and performing read assignment as per study-specific procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.

CLINICAL TRIAL IMAGING SPECIALIST

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform imaging data reconciliation per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Complete quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases reader for read assignment per the Standard Operating Procedure (SOP)and the Study Specific Procedures (SSP)
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Perform technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Maintain TMF and ensure appropriate study documents are filed for audit readiness
• Assist in the training of internal staff
• Other duties as assigned by manager

EDUCATION AND EXPERIENCE:

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Proficiency in MS Office and internet applications required
• Minimum of 2 years of experience in medical imaging required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

CLINICAL TRIAL IMAGING SPECIALIST II

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases ready for read assignment per the Standard Operating Procedure (SOP) and the Study Specific Procedures (SSP)
• Perform the project trainings for new team members and site trainings
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Communicate with readers about assigned reads, pending reads, and/or any other concerns when needed
• Communicate to the study team regarding issues that arise during the read assignment process
• Creation and/or review of image QC checklists, imaging manuals, site evaluation questionnaires, training material for imaging site personnel, and any other site required documents
• Perform technical training of imaging site personnel (on-site or telecon)
• Perform AG Mednet user acceptance testing (UAT) and documentation for new studies and enhancement for existing studies to confirm correct study set up
• Participate in the study related client and other meetings as and when required
• Assist with operational process improvements
• Perform other duties as assigned by manager

EDUCATION AND EXPERIENCE

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred
• Proficiency in MS Office and internet applications required
• Minimum of 3 years of experience in medical imaging required
• Minimum of 2 years of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of the drug development process and clinical trials process and/or experience working in a pharmaceutical environment preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

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

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure™ 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
• 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

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: 5 to 10% (domestic and/or international)

• Oversee the planning, execution, and completion of assigned clinical trials in accordance with study protocols, SOPs, and regulatory requirements.
• Manage clinical trial budgets, timelines, and resource allocation effectively.
• Select, train, and manage clinical investigative sites and vendors (e.g., CROs, central labs).
• Develop and maintain strong relationships with investigators and site staff, providing oversight and support.
• Ensure the collection, review, and verification of high-quality clinical data.
• Monitor trial progress, identify potential risks, and implement mitigation strategies.
• Prepare and review essential study documents, including protocols, informed consent forms, and case report forms.
• Liaise with regulatory authorities and ensure compliance with all applicable regulations (e.g., FDA, EMA, ICH-GCP).
• Prepare clinical study reports and contribute to regulatory submissions.
• Manage study team members, fostering collaboration and ensuring efficient workflow.

• Bachelor's degree in a relevant scientific discipline (e.g., Life Sciences, Nursing, Pharmacy). Advanced degree or equivalent experience strongly preferred.
• Minimum of 7 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
• Demonstrated success in managing multiple clinical trials simultaneously from initiation to closure.
• In-depth knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
• Proven experience in budget management and vendor oversight.
• Excellent project management, organizational, and leadership skills.
• Strong communication, interpersonal, and negotiation skills.
• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and electronic trial master files (eTMF).
• Ability to work independently and proactively in a remote setting.
• Experience with a variety of therapeutic areas is advantageous.