Clinical Research

• Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout
• Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements
• Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas
• Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives
• Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc
• Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct
• Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery
• Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones
• Drive inspection readiness as a continuous discipline across sites
• Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality
• Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization
• Provide oversight and quality assurance for vendor monitoring, escalating risks proactively
• Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize client trials
• Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner
• Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity
• Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution
• Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel
• Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer
• Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships

Clinical Trial Liaison – Clinical Research Lead

• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies.
• Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs.
• Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit.
• Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents.
• Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinating initial source review and update process.
• Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial.
• Updating current source documents according to new clinical study protocol amendments.
• Activating studies and visits at the appropriate time.
• Supporting Quality Control (QC) of source documents before it goes to the users.
• Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out.
• Maintaining a single tracker for the department to track source document design activities and the status of the activities.
• Maintaining version control of all source documents.
• Managing daily communication with site staff and other internal departments.
• Remaining up to date with all assigned Clinical Study Protocol for study.
• Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures.
• Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork.
• Participating in continuing education activities to maintain current knowledge of source document design and relevant software.
• Performing all other duties that may be requested or assigned.

Clinical Research Source Development Coordinator

• Ability to phone screen patients or caregivers in caring and empathetic manner.
• Document patient information correctly in the computer database.
• Schedule/reschedule patient screen and prescreen appointments.
• Manage incoming calls from patients interested in taking part in research studies.
• Evaluate eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with site clinic staff.
• Learn and maintain knowledge regarding clinical research studies including inclusion and exclusion criteria for different studies.
• Record contact status of patients and document information in the database.
• Review, call and update sponsor patient portals as needed.
• Perform all other duties that may be requested or assigned.

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