CLINICAL RESEARCH ASSOCIATE 1
Company: Allen Spolden
Location: Nashville
Posted on: September 28, 2024
Job Description:
Job Description
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.
Essential Duties And Responsibilities
- 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. Requirements
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.
- 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
- Self-motivated, assertive, and driven
Benefits
Dental, Medical, Vision, PTO and 401K
Keywords: Allen Spolden, Shreveport , CLINICAL RESEARCH ASSOCIATE 1, Healthcare , Nashville, Louisiana
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