Sr. Clinical Research Associate Contractor (United States)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Clinical Research Associate Contractor (sCRA I) to join our A-team (remote). As a Sr. Clinical Research Associate Contractor at Allucent, you are responsible for independently controlling and monitoring investigational sites, pro-actively detecting issues, providing solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. sCRA I can coordinate the training coaching and guidance of (s)CRA and assist in developing trial related processes, documents, and manuals.

Contract length: 3 months

In this role your key tasks will include:

• Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
• Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
• Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
• Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
• Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
• Collect and review regulatory documents as required.
• Prepare site visit and telephone reports.
• Responsible for multiple projects and must work both independently and in a team environment.
• May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
• Resolve site issues and determine status for IP shipment.
• Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
• May translate, coordinate translations or review completed translations of critical documents.
• Participate in feasibility and/or site identification activities.
• Assist the Project Team with the day-to-day management of clinical studies as required.
• Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
• Train, mentor and/or supervise junior staff.
• May be assigned as LCRA to a regional or global study.
• May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
• Conducts project co-monitoring, assessment visits and team training.
• Site contact for protocol clarifications and subject enrolment if CRA unavailable.
• Participate in the development of study newsletters communication as required.
• Assist with the development of project-specific training materials for team.
• Liaise with Business Development and make presentations to potential clients as required.
• May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
• Other responsibilities as required.

Requirements

• Based in the United States of America
• At least four years clinical monitoring experience and/or relevant clinical trial experience.
• Relevant life science degree / medical / nursing background, or combination of education and experience.
• Skills to mentor and train other CRAs in a positive and effective manner.
• In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
• Strong oncology therapeutic background
• Can demonstrate experience and knowledge in the CRO industry that will support POI’s management of clinical trials.
• Has shown ability to successfully manage people/project issues.
• Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
• Demonstrates the ability to define and meet proje