Clinical Research Associate (Clinical) - Remote - REF10590R
Company: ProPharma Group
Location: Las Vegas
Posted on: June 25, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
We have an exciting opportunity for a Clinical Research Associate
(CRA) Level 1 or 2. This person will play a key role in supporting
the conduct of clinical studies for molecular in-vitro diagnostics
(IVD). The CRA will conduct site monitoring visits following a
hybrid monitoring model. This role has flexible working
arrangements, with the option to work in the office or
- Based on experience the candidate will conduct site
co-monitoring or solo monitoring visits (pre-study, initiation,
routine monitoring and closeout) per monitoring plan and applicable
SOPs. Write comprehensive reports to reflect all activities
executed during visits and maintain accurate and complete action
- Site monitoring responsibilities will include assisting Sr CRAs
and CTMs with training and overseeing cross-functional site
personnel on study related procedures for the duration of the
study. You will also have an opportunity to conduct refresher
training for sites as required per clinical monitoring plan.
- Assists with study start-up activities including but not
limited to evaluation, selection, and activation of investigational
sites for clinical studies.
- Confirms qualifications of site and personnel, specifically the
Investigator and Site Staff, as well as confirming suitable
resources and facilities to properly conduct the study.
- Tracks enrollment activities, maintain applicable spreadsheets
for team collaboration, and develope contingency plans as needed,
to ensure sites remain on track with enrollment commitments.
- Extensive review of site Essential Documents (ED) within the
Investigator Site File (ISF) for accuracy and completeness.
Reconcile and ensure appropriate filing within the Trial Master
- Escalates site issues to Sr CRAs and CTMs to ensure transparent
and expedient communication between sites and study
- Works with Sr CRA's and CTM to ensure Investigator Agreements
(IA) and budgets are executed for assigned study sites.
- Assists with organizing IRB/EC submissions with follow through
to ensure successful outcomes.
- Ability to travel up to 70%
- Associates degree plus 4 years of job related experience; BS
- At least one (1) year of (CRA) monitoring experience in the
pharma, IVD or CRO industry
- Experience with clinical trial information systems
- A thorough understanding of clinical processes as well as GCP
and ICH guidelines
- Excellent communication, organizational skills, and attention
- Excited to 'wear many hats' and self-motivated to take on new
- Well organized and detail oriented
We celebrate our differences and strive to create a workplace where
each person can be their authentic self. We are committed to
diversity, equity, and inclusion. Employees are encouraged to
unleash their innovative, collaborative, and entrepreneurial
spirits. With a holistic approach as an Equal Opportunity Employer,
we provide a safe space where all employees feel empowered to
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***
Keywords: ProPharma Group, Las Vegas , Clinical Research Associate (Clinical) - Remote - REF10590R, Healthcare , Las Vegas, Nevada
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