Alycia Blair

Serve as the primary point of contact for all sponsor and Principal Investigator communications related to contracts and budgets
Review and approve all draft contracts and budgets prior to sponsor submission to
ensure:
o Accuracy
o Compliance
o Strategic positioning
Assign CRADA and budget development responsibilities to designated staff
Ensure consistency and standardization across all agreements and budgets
Contracts Management

Draft, review, and negotiate research agreements, including:
o Clinical Trial Agreements (CTAs)
o Cooperative Research and Development Agreements (CRADAs)
o Confidential Disclosure Agreements (CDAs)
o Subawards and MOUs

Serve as the sole communication channel with sponsors for all contract-related matters
Coordinate legal review with appropriate counsel (e.g., VA STAR attorneys)
Manage contract lifecycle from intake through full execution and activation
Track execution status and ensure timely progression of agreements

Budget Development & Financial Strategy

Oversee development of all study budgets to ensure alignment with:
o Protocol requirements
o Sponsor expectations
Review and approve all budget drafts developed by staff prior to submission
Lead or support budget negotiations with sponsors to ensure full cost recovery
Provide strategic guidance on budget positioning to maximize financial sustainability

Workflow Management & Delegation

Manage intake of all new study opportunities, sponsor inquiries, and PI requests
Assign CRADA and budget development responsibilities to appropriate staff (e.g.,
Budget/Contracts Analyst)
Oversee staff responsible for:
o Protocol review
o CRADA drafting using approved templates
o Budget development using internal tools

Process Improvement & Governance
Develop and enforce SOPs for contracts and budget workflows
Maintain and update templates, pricing tools, and negotiation strategies
Identify opportunities to improve efficiency, reduce start-up timelines, and mitigate risk
Ensure adherence to established workflow guardrails, including:
o Centralized communication through this role
o Mandatory review before sponsor submission
o Alignment with approved pricing structures

• Conduct Feasibility assessments to evaluate suitability of studies for site.
• Collaborate with site investigators and study teams to gather necessary information to access the site's capabilities.
• Assist site teams in the completion of all required tasks to meet department and project goals.
• Technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, urine/serum pregnancy testing, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator.
• Maintaining accurate dispensing logs, of administering medications.
• Actively recruiting for clinical trials with set time allotted each week for recruitment efforts.
• Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.

• Responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.
• Identifying, training/initiating, and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed; conducting remote site management activities.
• Study start-up activities such as working with site for collection of study start up documents, Assisting study start-up team with execution of CDAs.
• Tracking process of start-up activities in CTMS such as expected PSV/SIV, regulatory or IRB timelines.
• Managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately, and timelines are maintained.

• Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, urine/serum pregnancy testing, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator.
• Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third-party mixer or un blinded mixer/preparer of medication.
• Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events.
• Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts.
• Staff development and training responsibilities.

• Company Overview: (Formerly Regional Clinical Research)
• Responsible for the overall coordination, organization, and efficient implementation of clinical trials marketing, operations, and regulatory compliance.
• Works closely with the Principal Investigator to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.
• Quality Assurance of both studies and site.
• Hires, trains, and manages Clinical Research Coordinators, Assistant Clinical Research Coordinators, Patient Recruitment Coordinators, and the Laboratory personnel.
• Manages the processes of subject recruitment, appointment scheduling, informed consent, subject visits, source document preparation, Case Report Form and other document preparation and disposition, and regulatory documentation and reporting.
• (Formerly Regional Clinical Research)

• Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site.
• Proactively develops and executes recruitment plans that meet and exceed enrollment goals.
• Completes training on Clinical Trial Management System and maintains proper skills to update databases, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
• Attends investigator meetings.
• Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, urine/serum pregnancy testing, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
• Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.