35 Clinical Research Associate Jobs in Raleigh, NC
Novotech, Inc. is Hiring a Clinical Research Associate Near Raleigh, NC
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 comonitoring 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.
- 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
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.
Job Summary
Full Time
Wholesale
$63k-82k (estimate)
05/23/2024
07/04/2024
novotech-cro.com
WARSZAWA, MAZOWIECKIE
500 - 1,000
1997
DYLEWSKA MARIOLA ILONA
<$5M
Wholesale
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The job skills required for Clinical Research Associate include Clinical Research, Clinical Trial, Clinical Monitoring, Collaboration, Initiative, Time Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Associate positions, which can be used as a reference in future career path planning. As a Clinical Research Associate, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate. You can explore the career advancement for a Clinical Research Associate below and select your interested title to get hiring information.
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