clinical trial associate

Minerva Research Solutions

<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)
RlJhA3EJD3</div>

Clinical Trials Quality Assurance Associate (Night)

<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)
 
 
 Powered by JazzHR
 
 
 RlJhA3EJD3
</div>

Eventus Solutions Group

<div>Clinical Research Associate &ndash; Health Tech Innovation

Location: Burlingame, CA (Onsite) 
Position Type: Contract or Full Time

Help Shape the Future of Health Tech 
Join a team at the forefront of wearable technology and digital health innovation. This is more than a monitoring role&mdash;it&rsquo;s an opportunity to influence how next-generation medical devices improve lives. If you&rsquo;re an experienced Clinical Research Associate (CRA) who thrives in fast-paced environments and wants to make a tangible impact on groundbreaking clinical trials, we want to hear from you. 
What You&rsquo;ll Do
<ul>
<li>Lead site qualification, initiation, monitoring, and close-out visits to ensure compliance with protocols and regulatory standards.</li>
<li>Monitor studies with precision&mdash;verify source data, resolve queries, and maintain data integrity.</li>
<li>Build strong relationships with investigators and site teams to ensure smooth trial execution.</li>
<li>Drive risk-based monitoring strategies and implement corrective actions when needed.</li>
<li>Stay ahead of the curve on FDA regulations, ICH GCP guidelines, and evolving industry trends.</li>
<li>Collaborate cross-functionally with clinical operations, data management, and regulatory teams.</li>
<li>Prepare detailed monitoring reports and documentation that meet the highest standards.</li></ul> 


Qualifications for success:
<ul>
<li>Bachelor&rsquo;s degree in life sciences, nursing, or related field (Master&rsquo;s preferred).</li>
<li>5 or more years in clinical research, ideally with device studies.</li>
<li>2 or more years as a CRA or Study Monitor with hands-on experience in IMV, SQV, etc.</li>
<li>Experience with EDC systems and CTMS.</li>
<li>Experience with FDA regulations, ICH GCP, and device-related compliance.</li>
<li>Ability to travel up to 80%.</li>
<li>CCRA, CCRP, or CPM certification preferred.</li></ul> 


Why you&rsquo;ll love it here:

Culture: At Tech Mahindra, we are a culture of driving positive change, celebrating each moment, and empowering all to Rise drives us to dream, do, and become more.

Applicants can expect to make between $115,000 to $130,000 upon hire. Pay within this range will vary based upon experience, skills, certifications, education among other factors as required in the job description. Contract hourly rate is $55.00-62.00 / hour USD (contractors are not eligible for benefits under Tech Mahindra). 
Tech Mahindra also offers benefits like medical, vision, dental, life, disability insurance and paid time off (including holidays, parental leave, and sick leave, as required by law). The exact offer terms will depend on the skill level, educational qualifications, experience and location of the candidate. 
&ldquo;Tech Mahindra is an Equal Employment Opportunity employer. We promote and support a diverse workforce at all levels of the company. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, age, national origin, or disability. All applicants will be evaluated solely on the basis of their ability, competence, and performance of the essential functions of their positions with or without reasonable accommodations. Reasonable accommodations also are available in the hiring process for applicants with disabilities. Candidates can request a reasonable accommodation by contacting the company ADA Coordinator at ADA_Accomodations@TechMahindra.com.&rdquo;</div>

Clinical Research Associate – Health Tech Innovation

Ray-CRO

Clinical Research Associate (CRA) Opportunity &ndash; Saudi ArabiaRAY-CRO is expanding its operations in Saudi Arabia and is seeking a qualified Clinical Research Associate (CRA) to support regional clinical research activities and contribute to high-quality study execution.The successful candidate will be responsible for:<ul><li>End-to-end site management from initiation through close-out</li><li>Ensuring compliance with ICH-GCP, study protocols, and applicable regulatory requirements</li><li>Effective communication with investigative sites, sponsors, and internal teams</li><li>Proactive issue identification and resolution</li><li>Maintaining high standards of quality, timelines, and patient safety</li></ul>Location: KSA Applications: careers@ray-cro.comThis is an excellent opportunity to join a regional CRO with an expanding clinical research footprint in Saudi Arabia.Job Type: Full-timeWork Location: In person

Clinical Research Associate

CTI Clinical Trial and Consulting

<div><div>Senior Clinical Research Associate (home based) (Level dependent on experience)</div>
<div> 
To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. 
 
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. 
 
What You'll Do</div>
<ul><li>Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor.</li>
<li>Creates and implements subject enrollment strategies for assigned investigative sites.</li>
<li>Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.</li>
<li>Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.</li>
<li>Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.</li>
<li>Participates in development of CRFs and other study related documents</li>
</ul><div>What You Bring</div>
<ul><li>Bachelor&rsquo;s or Master&rsquo;s Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or</li>
<li>RN with Associate&rsquo;s Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience</li>
</ul><div>Why CTI?
<div>At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.</div>
<div>For that reason, we treat our team members with the respect they deserve, and our numbers show it:</div>
<ul><li>We support career progression &ndash; We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward</li>
<li>We value education and training &ndash; We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department</li>
<li>We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.</li>
<li>Our culture is unparalleled &ndash; We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry</li>
<li>We think globally and act locally &ndash; With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.</li>
<li>We are looking toward the future &ndash; We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs</li>
<li>Our work makes a difference &ndash; We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market</li></ul></div></div>

Senior Clinical Research Associate (level dependent on experience)

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Senior Clinical Research Associate (level dependent on experience)

Senior Clinical Research Associate (level dependent on experience)

Senior Clinical Research Associate (level dependent on experience)