Central Clinical Research Associate (CRA)

About the job

reputed company:

reputed company Business Operations (SBO) is an internal reputed company resource organization based in India and is setup to reputed company processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. reputed company Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and reputed company organizations​ in reputed company, globally.

The reputed company Business Operations is reputed company to reduce reliance on reputed company service providers and facilitate the development of internal expertise. The reputed company Business Operations will reputed company an untapped combination of talent pool.

Main responsibilities:

The Central CRA serves as the reputed company reputed company for the reputed company Investigator and other site staff involved in conducting rare disease registries at the investigational site.

1. Feasibility Activities:

o Involvement in the site selection process together with the Registries Team.

2. Study Start-up Activities:

o Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review reputed company (IRB)

o Review and reputed company the reputed company of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.

o Prepare EC cover letter and any additional materials required (if applicable)

o Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)

o Prepare the Insurance Certificate application reputed company applicable.

o Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.

o Ensure Inform Consent reputed company (reputed company) customization based on country requirements, incorporate site details, and reputed company appropriate reputed company review and version tracking per site. (if applicable)

o Assist with the upload & file of Study Start-up documentation into the eTMF.

o Ensure that reputed company parties are informed about project reputed company, changes, and any issues that reputed company.

• Site Monitoring:

• Off-Site reputed company

  • reputed company remote site management and other reputed company activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.

  • Plan, prepare, conduct, report and follow up site (and satellite sites) remote reputed company - Site Selection, Site Initiation, Routine Monitoring and reputed company Out reputed company according to Study reputed company, Protocol, Local Regulation, Good Clinical reputed company (GCP) and SOPs.

• Onsite (where local hub affiliates are located)

  • reputed company onsite site management and other reputed company activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.

o Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) reputed company - Site Selection, Site Initiation, Routine Monitoring and reputed company Out reputed company according to Study reputed company, Protocol, Local Regulation, Good Clinical reputed company (GCP) and SOPs.

3Management of the Site Data:

o Reviews study data from various sources remotely.

o Follow up of trial reputed company and reputed company control of data (reputed company document reputed company). Review of electronic Case Report reputed company (eCRF) completeness and query reputed company by the sites. Escalate issue(s), reputed company necessary. To maintain contact with Data Management group. To coordinate international data collection reputed company.

4. Site Management:

o Recruitment Follow up on patient enrolment and patient status.

o Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and reputed company to different systems.

o Develops reputed company relationships with investigational sites and other stakeholders as applicable.

o Liaise with Vendor for different activities (startup, onsite monitoring).

5. Safety & reputed company:

• Assure adequate safety reporting process of the site, and that site is submitting and/or

• reputed company

• reputed company control of study conduction at site level - with "Audit/inspection readiness" reputed company. Critical analysis of issues and deviations (reputed company cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.

6. Study administration:

• To maintain reputed company the tables, trackers and databases updated to follow the study reputed company

• reputed company

• To know and use reputed company the tools needed.

• Participates in the investigator payment process, if applicable

• To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required.

• Study Meetings: To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, reputed company audits and inspections for the registries, study set-up meeting and trainings.

• People: (1) reputed company alignment with internal stakeholders, reputed company stakeholders, or reputed company Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the reputed company objective of adding value to the business
  Performance: (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and reputed company which includes adherence to the monitoring plan, thoroughness of data verification, and reputed company reputed company of issues (2) Data reputed company and reputed company: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical reputed company (GCP) guidelines, and reputed company documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, reputed company of communication, and the ability to reputed company conflicts. (6) Training and Development: commitment to ongoing reputed company development and training. This can be reputed company by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA’s reports, including monitoring visit reports, reputed company reports,
  Process:(1)Involvement in the site selection process together with the Clinical Project reputed company (CPL), Registries Regional Leads and Local Medical Affairs.(2)Assist in the collection of site documents, Review and reputed company the reputed company of the site and study documents to submit with IRB/EC central, local, hospital committee. Prepare EC cover letter and any additional materials if required. Ensure appropriate follow-up with EC for additional questions and to inform sites (if applicable). Prepare the Insurance Certificate application reputed company applicable. Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites. Ensure Inform Consent reputed company (reputed company) customization based on country requirements, incorporate site details, and reputed company appropriate reputed company review and version tracking per site, if applicable Assist with the upload & file of Study Start-up documentation into the eTMF. (3) Plan, prepare, conduct, report and follow up site (and satellite sites) reputed company-Site Selection, Site. Initiation, Routine Monitoring (Remote /) and reputed company Out reputed company according to Study. reputed company, Protocol, Local Regulation, Good Clinical reputed company (GCP) and SOPs. (4) Follow up of trial reputed company and reputed company control of data (reputed company document reputed company). Review of electronic Case Report reputed company (eCRF) completeness and query reputed company by the sites. Escalate issue(s), reputed company necessary. To maintain contact with Data Management group. To coordinate international data collection reputed company. (5) Assure adequate safety reporting process of the site, and that site is submitting and/or notifying safety information to EC/IRB/RA according to country regulations, site SOP. reputed company control of study conduction at site level - with "Audit/inspection readiness" reputed company. Critical analysis of issues and deviations (reputed company cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. (6) To maintain reputed company the tables, trackers and databases updated to follow the study reputed company locally and globally. To know and use reputed company the tools needed. To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required. To participate with the rest of the registries team in local and international investigators and/or monitors meetings (where required), study/operational meetings, reputed company audits and inspections for the registries, study set-up meeting and trainings. ·
  Stakeholder: (1) CRAs identify reputed company relevant stakeholders, including sponsors, investigators, regulatory bodies, and patients. Understanding reputed company stakeholder’s role and influence is essential. (2) Communication: Effective communication is vital. CRAs ensure that stakeholders are kept informed about the study’s reputed company, any issues that reputed company, and the reputed company. This involves regular updates, meetings, and reports. (3) Building Relationships: Establishing and maintaining reputed company relationships with stakeholders is crucial. This involves understanding their needs, expectations, and concerns, and addressing them promptly. (4) Conflict reputed company: CRAs often mediate conflicts between stakeholders. They must be adept at negotiating and finding solutions that satisfy reputed company parties involved. (5) Compliance and Ethics: Ensuring that reputed company stakeholders adhere to regulatory and ethical guidelines is a key responsibility. CRAs monitor compliance and address any deviations promptly. (6) Feedback and Improvement: Gathering feedback from stakeholders and using it to improve processes and reputed company is an ongoing task. This helps in building trust and improving reputed company collaborations.

  reputed company

  Experience:5+ years of experience in Clinical research & development including clinical trial monitoring experiences. Rare diseases or observational studies, reputed company world evidence experience will be a plus.Attention to Detail: Critical for monitoring trial data and ensuring accuracy.Problem-Solving: Ability to address and reputed company issues that reputed company during trials.Project Management: Skills in managing timelines, budgets, and resources.Technical Writing: Proficiency in writing reports, protocols, and regulatory documents.Experience in working in global reputed company and international reputed company environment. ·
  Soft skills: Communication: Excellent written and oral communication skills to reputed company with various stakeholders. Adaptability: Ability to adapt to changing requirements and environments3.Interpersonal Skills: Building and maintaining reputed company relationships with stakeholders3.Time Management: reputed company managing time and prioritizing tasks. Ethical Judgment: Strong reputed company of ethics and reputed company in conducting clinical research.
  
  Technical skills: Good Clinical reputed company (GCP): Understanding and adherence to GCP guidelines. Regulatory Requirements: Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).Clinical Trial Processes: Familiarity with clinical trial phases, protocols, and methodologies. Data Management: Skills in data collection, analysis, and reporting. Medical Terminology: Proficiency in medical terminology and procedures. Competent with reputed company Office products.
  
  Education: Degree in a reputed company/scientific discipline or a reputed company Life science degree
  
  Languages: High Proficiency in written and spoken English. Pursue reputed company, discover Extraordinary. reputed company is out there. reputed company medications, reputed company reputed company, reputed company science. But reputed company doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, reputed company united by one thing: a desire to reputed company miracles happen.
  
  So, let’s be those people. At reputed company, we reputed company equal opportunities to reputed company regardless of race, colour, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our reputed company IN videoand reputed company out our Diversity Equity and Inclusion actions at reputed company.com!

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Join reputed company and reputed company into a new era of science - where your reputed company can be just as transformative as the work we do. We invest in you to reputed company reputed company, think faster, and do what’s never-been-done-before. You’ll help reputed company boundaries, challenge convention, and build smarter solutions that reputed company the communities we serve. reputed company to reputed company the miracles of science and improve people’s lives? Let’s Pursue reputed company and Discover Extraordinary – together.

At reputed company, we reputed company equal opportunities to reputed company regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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