Clinical Research Associate I - Trials Monitoring

Allen Spolden; Denver (CO); In loco; USD 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

Denver-based clinical research support professional sought to assist the clinical study team with protocols, site evaluations, and regulatory documentation. Responsibilities include site initiation visits, monitoring, report preparation, and archive maintenance, all while adhering to GCP and regulatory standards.

Requirements include a BA/BS or RN/BSN or equivalent, 1–2 years of clinical research experience, and strong written and verbal communication skills.

Competenze

• BA, BS, RN, BSN or equivalent.
• Basic knowledge and adherence to GCPs.
• 1–2 years of clinical research experience or equivalent.
• Strong attention to detail.
• Ability to multi-task.
• Unquestionable integrity and highest ethical standards.
• Excellent written and verbal communication skills.

Mansioni

• 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.

Conoscenze

Attention to detail

Communication skills

Multi-tasking

Integrity & ethics

GCP knowledge

Formazione

BA/BS, RN, BSN or equivalent

Descrizione del lavoro

Denver-based clinical research support professional sought to assist the clinical study team with protocols, site evaluations, and regulatory documentation. Responsibilities include site initiation visits, monitoring, report preparation, and archive maintenance, all while adhering to GCP and regulatory standards.

Requirements include a BA/BS or RN/BSN or equivalent, 1–2 years of clinical research experience, and strong written and verbal communication skills.