Job Description

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You\xe2\x80\x99ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you\xe2\x80\x99ll help make a positive difference in patients\xe2\x80\x99 lives.

Requirements

• Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and POI SOPs for monitoring requirements.
• Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
• Collects and reviews regulatory documents as required.
• Prepares site visit reports and telephone contact reports.
• May participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings.
• Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
• Works with Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA), regulatory team members or sponsor to secure authorization of regulatory documents and site contracts.
• Informs team members of completion of regulatory and contractual documents for individual sites.
• Attends Investigator Meetings (IM) and study specific training meetings.
• May translate, coordinate translations or review completed translations of critical documents.

• Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
• Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
• Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.
• Provides secondary in-house review of CRFs/eCRFs (if required).
• Works both independently and in a team environment.

Allucent