Clinical Research Associate 1
Denver, COFull-time
Behavioral Health Market Context
Apply Nowvia Career.io
Benefits
Dental CoveragePaid Time OffHealth Insurance
Job Description
ding 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.
<\/li><\/ul>
<\/div><\/span>
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.
<\/p>
• 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
<\/li><\/ul>
<\/div><\/span>
Benefits<\/h3>Dental, Medical, Vision, PTO and 401K<\/div><\/span>
<\/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.
<\/li><\/ul>
<\/div><\/span>
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.
<\/p>
• 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
<\/li><\/ul>
<\/div><\/span>
Benefits<\/h3>Dental, Medical, Vision, PTO and 401K<\/div><\/span>
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
Benefits
- •Benefits<\/h3>Dental, Medical, Vision, PTO and 401K<\/div><\/span>
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
More Jobs
- Physical Therapist - PRNat Therapy Management Corporation
- Registered Behavior Technician (RBT) - Glenrock, Wyomingat Soliant
- Licensed Marriage and Family Therapist - Onsite or Remote (LMFT, LMFTS, or LCMFT)at Therapymatch Inc. (DBA Headway)
- Remote Paid Study Participant – Flexible Schedule (Earn Up to $750/Week)at Apex Focus Group Inc.
- Intern Behavior Therapistat Achieve Beyond
- BCBA — Clinical Leader, Mentorship & Pathat Action Behavior Centers
- In-Home RBT: Flexible Hours & Growth Opportunitiesat Skillful Steps ABA
- Licensed Mental Health Therapist - Onsite or Onlineat Therapymatch Inc. (DBA Headway)
- Speech Therapist SLP for Home Healthat FeldCare Connects
- Work with Kids! Registered Behavior Technician (RBT) / BCAT / ABAT – Part-Timeat Behavia Therapy