Job Description

Job Type : Contract

Location : Abbott Park, Illinois

Pay : Great Pay!

Job Description

What you will be doing:

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
• Ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training and guiding investigators, study coordinators, and site staff.
• Communicate with site staff including coordinators, clinical investigators, and their site staff.
• Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
• Perform source documentation verification against case report form data, including informing site staff of any entry errors, ensuring good documentation practices are adhered to, and communicating protocol deviations appropriately.
• Verify that the investigator is enrolling only eligible subjects/samples.
• Ensure timely collection and review of study and regulatory documentation by obtaining, maintaining, and controlling all necessary records and documentation according to procedures and regulations.
• Be responsible for investigational product accountability and inventory.
• Verify and review adverse events to confirm accurate data reporting in accordance with the protocol.
• Assess the clinical research site's patient recruitment and retention success and offer suggestions for improvement.
• Complete monitoring reports and follow-up letters in a timely manner, including providing summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance.
• Build and maintain relationships with sites.
• Demonstrate intermediate knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
• Ensure validity of study by identifying and resolving discrepancies and obtaining missing data.
• Have basic knowledge of Abbott Platforms, assays, and assay data.
• Possess basic knowledge of statistics.
• Contribute to developing and writing clinical protocols, informed consent forms, case report forms, and other study aids for investigational products by addressing issues through interaction with appropriate personnel.
• Demonstrate initiative and problem-solving skills, along with critical-thinking skills.
• Provide solutions and contingency plans through comprehensive review of alternatives.
• Perform Quality Assurance Verification.
• Be responsible for training peers and serving as a trainer for contract research organizations (CROs) needed for additional monitoring support.
• Participate in at least 2 projects.

Experience you will need:

• Bachelor's degree in life sciences or clinical research preferred, or equivalent combination of education and work experience.
• 2-4 years of clinical research experience required or equivalent related work experience with a good understanding of specified functional area, application of business concepts, regulations, procedures, and practices.
• Clinical Research certification (e.g. ACRP, SOCRA) desired.
• Must be detail-oriented and able to multitask, prioritize, and manage time efficiently.
• Must have excellent written and verbal communication and presentation skills.
• Strong organizational and project management skills are required.
• Must be able to work independently and in groups with the ability to work cross-functionally.
• Self-directed and able to work within a fast-paced and constantly changing environment.
• Strong computer skills, including Microsoft Office Suite (Word, Excel, Outlook, etc.).

Our client asked me to submit 3 great people within the next few days. We work directly with the hiring manager and can arrange interviews within a few days

Arpit Tiwari

Job Tags

Similar Jobs