Qureos Mentor

Minerva Research Solutions

<div><h2 class="jobSectionHeader">Job description</h2>
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements. 
 
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process. 
 
Minerva Research Solution is looking for dynamic individuals in the role of Patient Enrollment Specialist responsible for screening new leads, conducting follow-ups, and documenting participants for assigned active clinical trials. This specialist contributes significantly to clinical trials by building a comprehensive database in the Clinical Trial Management System (CTMS) of willing and qualified study volunteers.
Industry:<ul><li>
Information Technology &amp; Services</li><li>
Hospital &amp; Health Care</li><li>
Clinical-Trials and Research Industry</li></ul>
Key Responsibilities:<ul><li>
Conduct phone interviews and screenings for prospective clinical study participants in US.</li><li>
Maintain an organized database of clinical study participants.</li><li>
Develop outreach strategies to enhance participant recruitment.</li><li>
Interact directly with study participants via phone calls, SMS, etc.</li><li>
Collaborate with Medical Staff (CRCs) to ensure adequate subject recruitment for each study.</li><li>
Enhance and maintain study documentation and volunteer records, including consent forms.</li><li>
Assist in sales, marketing, and outreach efforts as needed.</li><li>
Provide accurate study-related information to participants in US.</li><li>
Cultivate a safe, positive, and fast-paced work environment.</li><li>
Undertake other related duties and participate in special projects as assigned.</li></ul>
Behavioral Competencies:<ul><li>
Conceptual capability, problem-solving, and decision-making ability.</li><li>
Strong commitment to teamwork, work ethics, and etiquette.</li><li>
Effective planning and organizing skills with priority setting.</li><li>
Proactive knowledge and information sharing within the team.</li><li>
Customer-focused with strong communication skills.</li><li>
Active learning attitude with a continuous improvement mindset.</li></ul>
Minimum Qualifications:
Essential:<ul><li>
Bachelor&rsquo;s Degree in BDS, Pharm-D.</li><li>
Good knowledge of Clinical Trials.</li><li>
Computer literate with good knowledge of MS Office.</li><li>
Proficiency in the English language written and spoken both.(MANDATORY)</li><li>
Therapeutic Communication in English with US accent is preferred.</li><li>
6 months to 1 year experience in a relevant field.</li></ul>
Benefits:<ul><li>
Competitive salary and performance-based bonuses.</li><li>
Quarterly Bonus Structure.</li><li>
Medical health insurance coverage for you and your family (Spouse &amp; Children).</li><li>
Employees Old-age benefits coverage.</li><li>
40-hours Week.</li><li>
Exposure to US Market.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul>
Openings:<ul><li>
Equal opportunity employers</li><li>
Full-time</li><li>
On-site job (Night shift)</li></ul> 
Work Schedule Timings:<ul><li>
Monday to Friday</li><li>
7 PM to 3 AM (transport facility provided for female staff only and allowance for male employees, additional night shift allowance)</li></ul>
VqJLaFnOod</div>

US Patient Enrollment Coordinator (Evening Shift)

<div>
 
 Company Overview:
 
 
 
 Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.
 
 
 Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements.
 
 
 We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
 
 
 
 Job Purpose:
 
 
 
 The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies.
 
 
 
 Key Responsibilities:
 
 
 
 <ul>
 <li>
 Working as a regulatory professional to ensure effective and efficient regulatory support for the company's products and activities
 </li>
 <li>
 Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines
 </li>
 <li>
 Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications
 </li>
 <li>
 Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings
 </li>
 <li>
 Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner
 </li>
 <li>
 Build and maintain positive relationships with regulatory authorities and other external stakeholders
 </li>
 <li>
 Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance
 </li>
 <li>
 Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives
 </li>
 <li>
 Ensure timely and accurate reporting of regulatory activities and metrics
 
 
 </li>
 </ul>
 
 Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy
 </li>
 <li>
 01 years of experience in regulatory affairs, fresh graduates will also be preferred
 </li>
 <li>
 In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products
 </li>
 <li>
 Excellent communication, interpersonal, and problem-solving skills
 </li>
 <li>
 Ability to work independently and manage multiple projects simultaneously
 </li>
 <li>
 Strong attention to detail and accuracy
 </li>
 <li>
 Experience working in a fast-paced, deadline-driven environment
 
 
 </li>
 </ul>
 
 Benefits:
 
 
 
 <ul>
 <li>
 Competitive salary and performance-based bonuses
 </li>
 <li>
 Medical health insurance coverage
 </li>
 <li>
 Employees Old-age benefits coverage
 </li>
 <li>
 Professional learning and development support
 </li>
 <li>
 Generous vacation and paid time off
 </li>
 <li>
 Employee assistance programs for mental health
 </li>
 <li>
 Company-sponsored events and team-building activities
 </li>
 <li>
 Diverse, professional, and inclusive work environment
 </li>
 <li>
 Opportunities for career growth
 </li>
 <li>
 Cutting-edge technology and tools
 </li>
 <li>
 Family-friendly policies, including parental leave
 </li>
 <li>
 Commuter benefits or transportation assistance
 </li>
 <li>
 Social responsibility and community involvement programs
 
 
 </li>
 </ul>
 
 Openings:
 
 
 
 04 positions
 
 
 Full-time
 
 
 On-site job
 
 
 
 Work Schedule Timings:
 
 
 
 Monday to Friday
 
 
 Evening Shift (07 PM to 03 AM)
 
 
 (transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
 
 
 Powered by JazzHR
 
 
 bK2MpLypay
</div>

Regulatory Co Ordinator(Evening Shift)

<div>Company Overview: 
 
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle. 
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements. 
 
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process. 
 
Job Purpose: 
 
The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies. 
 
Key Responsibilities:<ul><li>
Working as a regulatory professional to ensure effective and efficient regulatory support for the company's products and activities.</li><li>
Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.</li><li>
Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.</li><li>
Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings.</li><li>
Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner.</li><li>
Build and maintain positive relationships with regulatory authorities and other external stakeholders.</li><li>
Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.</li><li>
Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.</li><li>
Ensure timely and accurate reporting of regulatory activities and metrics.</li></ul>
Qualifications:<ul><li>
Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.</li><li>
01 years of experience in regulatory affairs, fresh graduates will also be preferred</li><li>
In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.</li><li>
Excellent communication, interpersonal, and problem-solving skills.</li><li>
Ability to work independently and manage multiple projects simultaneously.</li><li>
Strong attention to detail and accuracy.</li><li>
Experience working in a fast-paced, deadline-driven environment.</li></ul>
Benefits:<ul><li>
Competitive salary and performance-based bonuses.</li><li>
Medical health insurance coverage.</li><li>
Employees Old-age benefits coverage.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional, and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul>
Openings:
04 positions 
Full-time 
On-site job 
 
Work Schedule Timings: 
Monday to Friday 
Evening Shift (07 PM to 03 AM) 
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
bK2MpLypay</div>

<div>JOB DESCRIPTION: 
 
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements. 
 
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process. 
 
Minerva Research Solution is looking for dynamic individuals with a passion for ensuring the highest standards in clinical trial data quality assurance. As a key player in our team, you will play a crucial role in maintaining the integrity and accuracy of clinical trial data.
Responsibilities:<ul><li>
Perform comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.</li><li>
Ensure data is recorded under sponsor protocol, GCP guidelines, industry guidelines, and agency regulations.</li><li>
Perform quality control checks; identify and track source documentation errors and non-conformances with requirements.</li><li>
Provide ongoing compliance support including but not limited to:</li><li>
Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans.</li><li>
Collaborating with the Clinical Team to share audit/inspection observations for lessons learned across protocol, and/or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs).</li><li>
Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.</li><li>
Assist in preparing for all Sponsor and FDA audits.</li><li>
Assist in conducting internal audits to review key processes.</li><li>
Provide appropriate support to assigned cross-functional workgroups.</li><li>
Establishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement.</li><li>
Query resolution and data entry and questionnaire preparation regarding the respective studies.</li><li>
Other related Quality Assurance projects as assigned.</li><li>
The QA Associate will report to the Quality Assurance Lead</li></ul>
Knowledge, Education, and Experience:<ul><li>
Qualified Profession with strong medical background (Pharm-D, MBBS, BDS etc) with a keen interest in Clinical Research are strongly encouraged to apply.</li><li>
In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials.</li><li>
Knowledge of IRB requirements.</li><li>
1+ years in work related to Quality Control / Quality Assurance area in clinical research will preferred..</li><li>
Experience including external clinical/regulatory and document auditing will be a plus</li></ul>
Skills and Abilities:<ul><li>
Good communication skills (interpersonal, written, verbal)</li><li>
Strong attention to detail and good time management skills</li><li>
Flexible attitude concerning work assignments</li><li>
Ability to manage multiple and varied tasks in a fast-moving environment</li><li>
Ability to interact professionally at all levels within the organization.</li><li>
Knowledge of the HIPAA Privacy Act and its application to clinical research.</li></ul>
Benefits:<ul><li>
Competitive salary and performance-based bonuses.</li><li>
Medical health insurance coverage.</li><li>
Employees Old-age benefits coverage.</li><li>
Flexible work hours and remote work options.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional, and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul>
Openings:
04 positions 
Full-time 
On-site job 
 
Work Schedule Timings: 
Monday to Friday 
Evening Shift (07 PM to 03 AM) 
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
vapSso9DaM</div>

Clinical Trials Quality Assurance Associate (Night)

Join Minerva Research Solutions and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Minerva Research Solutions

ABOUT_COMPANY

US Patient Enrollment Coordinator (Evening Shift)

Regulatory Co Ordinator(Evening Shift)

Regulatory Co Ordinator(Evening Shift)

Clinical Trials Quality Assurance Associate (Night)