Clinical Research Associate 1

Benefits

Qualifications

• •To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
• •Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• •BA, BS, RN, BSN or equivalent
• •Basic knowledge and adherence to GCPs
• •1 -2 years of clinical research experience or equivalent experience or training
• •Strong attention to detail
• •Ability to multi -task
• •Unquestionable integrity and highest ethical standards
• •Excellent written and verbal communication skills
• •<\/li>
• •Self -motivated, assertive, and driven
• •8 more items(s)

Responsibilities

• •Responsible for providing Clinical Research support for all clinical trials
• •Under the direction of supervisor or designee, this position will serve as support for the clinical study team
• •Participate and assist in design and preparation of protocols and case report forms
• •Generate clinical SOPs, policies, charters, and plans according to US and international guidelines
• •Participate in the evaluation of potential clinical sites according to established criteria of acceptability
• •Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions
• •Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials
• •Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions
• •Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites
• •Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission
• •Assist with the maintenance of clinical archive and electronic files
• •Other tasks as assigned
• •9 more items(s)