Clinical Research Associate Position Available In Charleston, South Carolina
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Company:
Unclassified
Salary:
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Job Description
Job Description:
Job Description:
- CRAs primary responsibility is to buildrelationships with Principal Investigators, study co-ordinators,pharmacists, and all relevant site trial personnel to ensure theefficient, expedited, and smooth management of clinical trials.
- Foster internal and external customer relationships to ensure focuson efficient, timely and productive project delivery as per studyrequirements and timelines.
- In collaboration with the In-houseClinical Research Associate (IHCRA) and Regulatory Start-UpAssociate (RSA), prepare site essential documents, and support theethics and regulatory submission and approval processes as needed.
- In collaboration with Regulatory Start-up (RSU) Team, understandthe requirements of applicable local and international regulatoryrequirements as relevant to specific clinical trials.
- Ensurerecruitment of participants as per the site target. Drive siterecruitment and engagement initiatives and prepare site-specificrecruitment plan(s) and update as required.
- Monitoring ofinvestigational sites as per ICH GCP (Monitoring) and the ClinicalMonitoring Plan (CMP) for each study.
This includes all monitoringvisit types across all phases of a clinical trial including SiteSelection, Site Initiation, Site Monitoring and Site Close Out,unblinded pharmacy visits, and co-monitoring visits. Visits can beconducted either onsite or remote as per CMP. Experience andQualifications
- Graduate in a clinical or life sciences-relatedfield. Relevant experience/qualifications in allied professions mayalso be considered.
- Must have good time management skills,attention to detail, be able to work well in a team, and becomputer literate.
- Preferably experience of working in theresearch, pharmaceutical industry or a related field per job levelas follows:
- At least 2-3 years of Clinical Research Associateexperience in the Clinical industry.
- Excellent interpersonal andteam skills with a genuine commitment to contributing to thedevelopment of innovative treatments
EEO:
Mindlance is an EqualOpportunity Employer and does not discriminate in employment on thebasis of -Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.