Clinical Research

• 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

• Full accountability for country-level study delivery and performance
• Serve as the client’s voice within Civia, ensuring their priorities, timelines, and standards are understood and met across all functions
• Maintain disciplined oversight of start-up, recruitment, regulatory progress, data quality, and site performance
• Drive immediate cross-functional action when performance deviates from plan
• Lead structured governance routines with clarity, transparency, and solution orientation
• Ensure ongoing audit and inspection readiness across all study activities

Clinical Trial Manager

• Participate in the development, coordination, monitoring, and implementation of research strategies for clinical trials
• Perform documentation, tracking, data abstraction and collection
• Work with Pharm D on dosage and titration of study drug
• Manage drug treatment schedules
• Educate nurses regarding studies/trials with participating children
• Attend clinical coordinator meetings
• Assure that patient visits are scheduled accordingly
• Collaborate with principal investigators to resolve implementation problems
• Educate patients and/or family members about study requirements
• Participate in recruitment of potential protocols for activation
• Review and discuss clinical procedures within the unit with new employees

Clinical Research Coordinator – Department of Pediatrics

• Support site start‑up activities, including feasibility assessments, regulatory document collection, and staff registration with sponsors.
• Maintain communication channels and contact lists for all network affiliates.
• Provide training and ongoing support to site personnel; assist in developing training tools and job aids.
• Coordinate network meetings, teleconferences, agendas, and minutes.
• Track site performance, protocol status, and accrual metrics.
• Assist with contracting processes, including site agreements, work orders, and regulatory submissions.
• Collaborate with website and communications teams to maintain timely updates.
• Ensure adherence to study protocols, IRB requirements, and federal/state regulations.
• Oversee data collection, data quality review, and reporting for the regional locations.
• Maintain regulatory documentation, deviation/violation tracking, and staff credentialing and training.
• Communicate with sponsors, NCTN groups, and investigators throughout the project lifecycle.
• Assist with eligibility review, enrollment processes, and participant follow‑up as needed.
• Conduct remote or on‑site study start up meetings, monitoring visits and prepare follow‑up documentation.
• Work with Informatics teams to implement workflows and data systems.
• Prepare project status reports for leadership and stakeholders.
• Develop tools, workflows, and tracking systems to support project and network operations.
• Assist in creating educational materials and resources to support clinical trial awareness.
• Contribute to SOP development and process improvement initiatives.
• Coordinate research team meetings and administrative tasks.
• Expected to provide training, guidance, and support to research staff. May serve as project or program lead as assigned.

Research Network & Project 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.

Clinical Research Patient Recruiter

• Executes statistical analyses plans independently
• Collaborates with project team members to implement the study design and statistical analyses plans
• Conducts review of administrative claims, electronic medical records, survey and clinical data
• Develops and implements prediction models for member and provider-based interventions
• Researches and analyzes broadly defined business scenarios, trends, and patterns
• Provides technical/analytical advice to staff
• Compiles results of studies for journal publication

See all jobs on JobTailor

Clinical Research Source Development Coordinator

Clinical Trial Manager

Clinical Research Coordinator – Department of Pediatrics

Research Network & Project Coordinator

Clinical Research Patient Recruiter

Biostatistician – Health Services Research