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.
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Essential Duties And Responsibilities<\/b>
<\/p>- Participate and assist in design and preparation of protocols and case report forms.
<\/li> - Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
<\/li> - Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
<\/li> - Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
<\/li> - Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
<\/li> - Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
<\/li> - Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
<\/li> - Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
<\/li> - Assist with the maintenance of clinical archive and electronic files.
<\/li> - Other tasks as assigned.
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Requirements<\/h3>
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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- BA, BS, RN, BSN or equivalent
<\/li> - Basic knowledge and adherence to GCPs
<\/li> - 1 -2 years of clinical research experience or equivalent experience or training
<\/li> - Strong attention to detail
<\/li> - Ability to multi -task
<\/li> - Unquestionable integrity and highest ethical standards
<\/li> - Excellent written and verbal communication skills
<\/li> - Self -motivated, assertive, and driven
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Benefits<\/h3>
Dental, Medical, Vision, PTO and 401K<\/div><\/span>
