The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Responsibilities:
• CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
• Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
• In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
• In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
• Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
• Monitoring of investigational sites as per ICH GCP 5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co monitoring visits. Visits can be conducted either onsite or remote as per CMP.
• Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
• Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
• Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
Minimum Qualifications & Experience:
• Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
• Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
• Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
• At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
• Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
Salary Band – Clinical Research Associate – $80,000USD-$125,000USD – Salary offered will be based on candidates experience level.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Location: Charleston, SC, US
Offer Expires: 2024-10-30 00:00:00
Job Posting Language: en
Qualifications:
- Graduate in a clinical or life sciences-related field
- Relevant experience/qualifications in allied professions may also be considered
- Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate
- Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
- At least 2-3 years of Clinical Research Associate experience in the Clinical industry
- Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
Responsibilities:
- Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs
- CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials
- Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines
- In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed
- In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials
- Ensure recruitment of participants as per the site target
- Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required
- Monitoring of investigational sites as per ICH GCP 5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study
- This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co monitoring visits
- Visits can be conducted either onsite or remote as per CMP
- Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs
- Ensure safety issues are reported to the sponsor promptly
- Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan
- Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol
Benefits:
- Salary Band – Clinical Research Associate – $80,000USD-$125,000USD – Salary offered will be based on candidates experience level
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