Consulting Opportunities

We have a high demand for experienced CRCs for our pharma and investigational site sponsors. We are seeking individuals with two to three years of experience with clinical trials, open to new opportunities for immediate discussion:

• CRCs help sites support, facilitate, and coordinate daily clinical trial activities.
• Collaborate and coordinate with the principal investigator (PI) on general study preparation and administrative duties.
• Prepare and review protocols including the budget, informed consent, case report forms, regulatory binders, and other study documents.
• Perform regulatory management of protocols, including preparation of safety reports, amendments/modifications, compliance renewals, and sponsor communications.
• Manage the conduct of research by screening subjects for eligibility, registering participants, coordinating tests and procedures, collecting data, ensuring timely completion of case report forms, collecting, and submitting study documents to the sponsor, and generally working with the PI to manage the study’s day-to-day activities.

Bring your talent to Advarra — we have an immediate demand for experienced project managers to support the delivery of our clinical trial support services for our sponsors. We are seeking individuals with project management experience with clinical trials, open to new opportunities for immediate discussion.

• As a project manager (clinical), you will apply your knowledge and expertise in project management in partnership with the project team, stakeholders, and the client.
• Accountable for the execution of the project delivery, by procuring and managing resources, setting, and meeting project timelines, and will be the primary point of contact for service-related client communications and project status. This is both an internal and external client-facing position.

Advarra offers engaging roles within regulatory affairs for individuals that want to make a difference. We are seeking individuals who have experience working in the pharmaceutical industry to provide strategic and tactical advice to teams to advance timely research and development while ensuring compliance.

• Individuals will need to have a solid working knowledge of the drug development process and regulatory requirements as well as understand and interpret complex scientific issues.
• Develop and lead strategies to maximize global regulatory success towards the achievement of program objectives.

Our clinical quality assurance roles vary from part-time to full-time, and most are three months to two years in length. Depending on our client, this role could focus on many areas in quality, defining, implementing, and optimizing quality strategy. We are looking for team members who possess some or all of the following:

• Strong quality management skills
• Manage quality events/issues
• Support complex clinical programs with multiple clinical research studies
• Contract research organization (CRO) and site management
• Manage compliance across business functions — quality and clinical
• Manage sponsor responsibilities and requirements at sites
• Inspection readiness
• Support inspection activities
• Manage investigations
• Work with teams to gather information
• Manage, review, and document processes and decisions
• Good follow-up skills to ensure actions are initiated and closure occurs in a timely manner
• Assist with scheduling and reviewing audit reports
• Perform quality assurance (QA) administrative tasks
• Senior-level knowledge of the clinical space and an understanding of the regulatory requirements
• Support clinical teams and attend clinical team meetings to identify issues and support decisions from a QA perspective
• Study oversight
• Data quality and data integrity
• Training records
• Reports and key performance indicators (KPIs)
• QA audits
• Study team lists
• Protocol deviations and corrective and preventive actions (CAPAs) perform vendor oversight

Advarra Consulting is seeking new talent to join our global expert community. Make a meaningful impact on research and development. We have immediate openings for medical writers with relevant knowledge, skills, and expertise to deliver high-quality scientific content for projects to support our global pharmaceutical clients.

As a medical writer:

• Lead the development of clinical, scientific, and regulatory documents while working in a cross-functional team.
• Individuals will need to have relevant scientific experience and the ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types.