Clinical Research Associate II

Zohorecruit; Memphis (TN); On-site; USD 52,000 - 78,000; Full time

Job summary

Zohorecruit in Memphis, Missouri, is seeking a Clinical Research Support specialist to assist the clinical study team under supervision. You will help design protocols, prepare case report forms, and draft SOPs and regulatory plans in line with US and international guidelines.

As part of the role, you will evaluate potential sites, coordinate budgets and contracts, initiate studies, monitor progress through site visits, and prepare reports for regulatory submission.

Qualifications

• Bachelor's degree or RN/BSN credential
• GCP knowledge and adherence to guidelines
• 1-2 years of clinical research experience or equivalent training
• Strong attention to detail and ability to multi-task
• Excellent written and verbal communication skills

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.
• 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.

Skills

Excellent written and verbal comms

Strong attention to detail

Ability to multi-task

Unquestionable integrity and ethics

GCP knowledge

Education

BA, BS, RN, BSN or equivalent

Job description

• Industry Pharma/Biotech/Clinical Research


• Work Experience 1-3 years


• City Memphis


• State/Province Missouri


• Country United States

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.

• 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