Immediate Joiners Job Summary: We are looking for a motivated and detail-oriented Clinical Research Associate (CRA) – I to join our Clinical Research Operations team. The CRA will be responsible for monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. This role involves close collaboration with site staff, project managers, and cross-functional teams to support the successful execution of clinical studies. Key Responsibilities: Perform site monitoring visits (pre-study, initiation, routine, and close-out) in accordance with the monitoring plan. Assist in site selection and feasibility assessments. Ensure trial sites adhere to the study protocol, SOPs, and applicable regulatory guidelines. Verify source documents and ensure accurate data collection and reporting. Maintain regular communication with site staff to ensure smooth trial conduct and resolve issues proactively. Document and report findings in visit reports and follow-up letters. Support site start-up activities including document collection and regulatory submissions. Track subject recruitment and data entry progress. Coordinate with clinical project teams and contribute to team meetings. Maintain study documentation and Trial Master File (TMF) compliance. Willingness to travel for site visits and monitoring activities as required by the study. Ensure timely identification, documentation, and escalation of protocol deviations, safety concerns, or compliance issues. Contribute to audit readiness by ensuring all monitoring and site activities are well documented and compliant. Provide input to improve study tools, processes, or monitoring practices based on site feedback and field experience. Support timely resolution of site queries and follow-up on pending actions from monitoring visits. Maintain continuous awareness of project timelines and deliverables, and take responsibility for meeting assigned milestones. Skills : Excellent communication and interpersonal skills. Strong organizational and time management abilities. Proficient in MS Office tools (Word, Excel, Outlook, PowerPoint). Attention to detail and ability to work independently in a dynamic environment. Adaptability to work in a small team and contribute to the setup of processes and systems. Education: Bachelor’s or Master's degree in Life Sciences, Pharmacy, Nursing, or related healthcare field. Certification in Clinical Research is preferred. Working knowledge of GCP, ICH guidelines, and basic regulatory environment. Experience: Minimum 1 years of experience in clinical research, preferably in roles supporting trial operations or site management. Hands-on involvement in study coordination, site communications, or regulatory documentation. Job location: ProRelix Services LLP, Pune Work mode : Office based About company: ProRelix Research (ProRelix Services LLP) is a global clinical research organization with presence in India and USA. We are a full service clinical trial solution provider with high reputation in industry. If you are passionate and possess enthusiasm to develop and embark on a fulfilling career in clinical research industry, we encourage you to apply. Join us in out of box thinking environment where your skills and creativity will be admired for continuous personal growth. Company website: www.prorelixresearch.com To apply: [email protected] Job Type: Full-time Schedule: Day shift Monday to Friday Work Location: In person
Immediate Joiner Job Summary: We are seeking a highly motivated and detail-oriented Clinical Trial Assistant (CTA) - I to join our clinical operations team. The CTA will support the execution of clinical trials by providing administrative and coordination assistance. This is an entry-level position ideal for recent graduates or those with up to 6 months of experience in clinical research. Key Responsibilities: Assist in the preparation, distribution, and tracking of essential clinical trial documents. Maintain Trial Master File (TMF) and ensure completeness and accuracy. Coordinate meetings, prepare agendas, and take minutes for clinical study team meetings. Support the site management team with regulatory submissions and communications. Track clinical trial milestones, patient enrollment, and visit schedules. Assist with vendor coordination and trial supplies management. Maintain study-specific databases and logs. Ensure compliance with Good Clinical Practice (GCP), standard operating procedures (SOPs), and regulatory requirements. Provide general administrative support to the clinical team. Skills : Basic understanding of clinical research and GCP guidelines. Strong organizational skills and attention to detail. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Good written and verbal communication skills. Ability to work in a team-oriented and deadline-driven environment. Willingness to learn and take on increasing responsibilities. Education: Masters in Life Sciences, Pharmacy, Nursing, or a related field. Experience: 0 to 6 months of experience in clinical research or related healthcare field. Job location: ProRelix Services LLP, Pune Work mode : Office based About company: ProRelix Research (ProRelix Services LLP) is a global clinical research organization with presence in India and USA. We are a full service clinical trial solution provider with high reputation in industry. If you are passionate and possess enthusiasm to develop and embark on a fulfilling career in clinical research industry, we encourage you to apply. Join us in out of box thinking environment where your skills and creativity will be admired for continuous personal growth. Company website: www.prorelixresearch.com To apply: [email protected] Job Type: Full-time Schedule: Day shift Monday to Friday Work Location: In person
Responsibilities: 1. Lead all data management aspects of a clinical study, starting from study set-up till close out. 2. Function as a single point of contact on multiple clinical trials involving client communications and collaboration with various stakeholders like Biostatistician, Programmers, Medical Monitors, Project Managers, Quality Control, Safety Managers, Third-Party Vendors, etc. to meet the project timelines. 3. Documentation of all clinical data management documents to match regulatory and SOP’s. 4. Direct communication with customer for data management timelines and work updates. 5. Maintain the data management study files in the audit ready condition. 6. Manage, monitor and allocate tasks to data operations team members on a regular basis to ensure milestones meet timelines and quality deliverables. 7. Establish strong coordination with data operations team, functional leads, project managers and all other stake holders. 8. Serve as the escalation point for unresolved data issues or queries, work with client data managers, vendors and internal team members for resolution. 9. Ensure appropriate resources are assigned to meet project deliverables. 10.Ensure service and quality meet agreed upon specifications as per the DMP and contract/SOW. 11.Implement quality management plans across multiple projects. Track service performance and provide leadership to identify root causes of issues and implement remedial actions. 12.Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organize and drive change. 13.Train and mentor data management and medical coding team in DM expertise. 14.Coordinate with third party vendors. E.g- CDMS, Medical dictionaries. 15.Ensure that data is reliable and valid so it can be used for analysis and regulatory submission. 16.Create and design Case Report Forms (CRF), design and test databases, integrate medical dictionaries, prepare edit checks, and perform User Acceptance Testing (UAT). Prepare documents like the Data Management Plan, CRF Completion Guidelines, and Data Validation plan. 17. Capture data, clean it, reconcile it, perform medical coding, and validate it. Regularly evaluate the data, which is called Interim Analysis. 18.Freeze and lock all clean data, which puts it into read-only mode. Lock the database and archive all documents. Education: A bachelor’s degree in life sciences, clinical research, pharmacy, or a related field. A master’s degree or relevant certifications (e.g., clinical research, PMP) would be an advantage. Experience: 08 Years Skills: MS-Office, Project Management, Clinical Data Management, Collaboration, Mentoring, Leadership, Interpersonal Communication, Quality Management, Risk Management. Other requirements: Technology- Leading CDMS software’s. Hard skills: Study Setup/Startup, Study Closeout, Clinical Trial Methodologies, Data Cleaning Methods, Specs Writing, Report Creations, Cdash, Cdisc, Medical Terminology/Coding, Lab/Vendor/Third Party Reconciliation, Query Management, Data Quality, Inspection/Audit, Drug Development. CTC: 10-15 LPA
Immediate Joiners Only Responsibilities: Lead all data management aspects of a clinical study, starting from study set-up till close out. Function as a single point of contact on multiple clinical trials involving client communications and collaboration with various stakeholders like Biostatistician, Programmers, Medical Monitors, Project Managers, Quality Control, Safety Managers, Third-Party Vendors, etc. to meet the project timelines. Documentation of all clinical data management documents to match regulatory and SOP’s. Direct communication with customer for data management timelines and work updates. Maintain the data management study files in the audit ready condition. Manage, monitor and allocate tasks to data operations team members on a regular basis to ensure milestones meet timelines and quality deliverables. Establish strong coordination with data operations team, functional leads, project managers and all other stake holders. Serve as the escalation point for unresolved data issues or queries, work with client data managers, vendors and internal team members for resolution. Ensure appropriate resources are assigned to meet project deliverables. Ensure service and quality meet agreed upon specifications as per the DMP and contract/SOW. Implement quality management plans across multiple projects. Track service performance and provide leadership to identify root causes of issues and implement remedial actions. Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organize and drive change. Train and mentor data management and medical coding team in DM expertise. Coordinate with third party vendors. E.g- CDMS, Medical dictionaries. Ensure that data is reliable and valid so it can be used for analysis and regulatory submission. Create and design Case Report Forms (CRF), design and test databases, integrate medical dictionaries, prepare edit checks, and perform User Acceptance Testing (UAT). Prepare documents like the Data Management Plan, CRF Completion Guidelines, and Data Validation plan. Capture data, clean it, reconcile it, perform medical coding, and validate it. Regularly evaluate the data, which is called Interim Analysis. Freeze and lock all clean data, which puts it into read-only mode. Lock the database and archive all documents. Education: A bachelor’s degree in life sciences, clinical research, pharmacy, or a related field. A master’s degree or relevant certifications (e.g., clinical research, PMP) would be an advantage. Experience: 8 years Skills: MS-Office, Project Management, Clinical Data Management, Collaboration, Mentoring, Leadership, Interpersonal Communication, Quality Management, Risk Management. Other requirements: Technology- Leading CDMS software’s. Hard skills: Study Setup/Startup, Study Closeout, Clinical Trial Methodologies, Data Cleaning Methods, Specs Writing, Report Creations, Cdash, Cdisc, Medical Terminology/Coding, Lab/Vendor/Third Party Reconciliation, Query Management, Data Quality, Inspection/Audit, Drug Development. CTC: As per Industry Standards Job location: ProRelix Services LLP, Pune Work mode : Office based About company: ProRelix Research (ProRelix Services LLP) is a global clinical research organization with presence in India and USA. We are a full service clinical trial solution provider with high reputation in industry. If you are passionate and possess enthusiasm to develop and embark on a fulfilling career in clinical research industry, we encourage you to apply. Join us in out of box thinking environment where your skills and creativity will be admired for continuous personal growth. Company website: www.prorelixresearch.com To apply: career@prorelixresearch.com Job Type: Full-time Pay: ₹83,000.00 - ₹125,000.00 per month Ability to commute/relocate: Karvenagar, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred) Application Question(s): Are you immediate joiner? Are you open for work from office, 5 days a week? Work Location: In person