Clinical Research

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans)
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place
• Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver
• Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
• Conduct regular team meetings and communicate appropriately to achieve objectives
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development
• Adopt corporate initiatives and changes and serve as a change advocate when necessary
• May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings
• Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership
• May mentor and coach new peers as they assimilate into this role
• May attend site visits as applicable in support of project delivery

Senior Clinical Trial Manager

• 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

• Develop medical plans and coordinates with Medical Directors
• Perform medical reviews of data listings
• Author and review medical data queries
• Manage project scope and quality of deliverables
• Collaborate with study team members to identify risks

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

• Partner cross-functionally with Project Management, Business Development, Commercial Finance, and Legal to ensure financial risks are identified and addressed early in the study lifecycle
• Establish and maintain operating mechanisms that improve visibility into study financial performance, including budget tracking, variance analysis, and risk forecasting
• Translate financial insights into actionable recommendations that influence operational and commercial decision-making
• Lead continuous improvement initiatives to enhance financial processes, reduce cycle times, and improve data quality and reporting consistency
• Drive accountability across stakeholders for financial performance
• Coordinate and oversee sponsor financial audits, ensuring compliance with contractual terms, regulatory expectations, and audit readiness standards
• Build, lead, and develop a high-performing, globally distributed finance team

Operations Finance Director – Clinical Research Central Laboratory

• Provide leadership and direction to clinical site management team members from study start through to closure
• Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to Primary Sponsor Contact
• Manage monitoring deliverables to achieve the study budget and identify out-of-scope activities

Senior Clinical Trial Manager – CNS

• Drive the execution of Lilly clinical trials through exceptional investigator engagement and site performance management
• Ensure Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight
• Combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies
• Serve as trusted partners to investigators, building strong relationships that improve return on enrollment
• Partner closely with internal Lilly teams to ensure that insights from the field shape development strategies
• Lead site-level strategy and risk planning to ensure predictable enrollment and data delivery

Associate Director, Clinical Research Lead – East Coast/Midwest

• Coordinate and manage oncology clinical trials by recruiting, screening, consenting, and enrolling participants while ensuring adherence to study protocols and regulatory requirements
• Deliver direct patient care in a research setting, including medication administration, chemotherapy delivery, patient education, and monitoring for adverse events and treatment compliance
• Oversee study operations and compliance, maintaining regulatory documentation, reporting adverse events, supporting audits, and ensuring alignment with institutional policies, SOPs, and federal guidelines
• Collaborate with investigators, sponsors, and cross-functional teams to execute study activities, resolve issues, support monitoring visits, and contribute to study start-up and closeout processes
• Support financial and data management efforts, including budget development, tracking study milestones, entering and validating clinical data, and ensuring data accuracy, security, and completeness

Clinical Research Nurse Coordinator

• Lead biostatistics representation on project or study teams and provide statistical expertise.
• Define statistical methodologies, analyze data, and report results for clinical development plans.
• Train and supervise contract statisticians, ensuring quality deliverables.
• Assist in addressing statistical issues in regulatory, legal, or other challenges.
• Serve as a peer reviewer and internal consultant on broad statistical issues.
• Participate in process improvement initiatives and mentor new/junior biostatisticians.
• Conduct modeling and simulations as needed.
• Collaborate closely with study or project teams for data interpretation and reporting.
• Work with statistical programmers, data management, and vendors to deliver analysis results.
• Collaborate with medical writers to complete study reports and manuscripts.
• Supervise FSP statisticians in assigned tasks.

Senior Principal Biostatistician

• Coordinating and conducting clinical trial procedures according to protocol requirements
• Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator
• Collecting and documenting patient data accurately and efficiently
• Assisting in patient recruitment, screening, and enrollment processes
• Providing nursing care and support to trial participants
• Collaborating with interdisciplinary teams to ensure trial compliance and quality data collection

Clinical Research Nurse

• Oversee and administer research study and associated activities
• Assists in project planning, ensuring that established work scope, study protocol and regulatory requirements are followed
• Recruit and coordinate research subjects, as appropriate
• Serve as principle administration liaison for the project
• Oversee and coordinate the provision of administrative and staff services to investigators
• Develop and maintain record keeping systems and procedures
• Promote safety and confidentiality of research participants at all times
• Adhere to OSHA, GCP, GLP, and infection control procedures
• Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures
• Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data
• Document all correspondence and communication pertinent to the research
• Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization

Clinical Research Coordinator

• Provide leadership and direction to clinical site management team members from study start through to closure
• Serve as Site Management primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: 1.)Primary Sponsor contact 2.)Investigator and Bid Defense Meetings 3.)Internal and External study team calls 4.)Project-specific Audits / Inspections
• Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities
• Oversee compliance to the Clinical Monitoring Plan, including site visits, outstanding trip reports and visit follow up letters

• Knowledgeable in regulatory and institutional policies and processes
• Is responsible for all aspects of managing and documenting Investigational Product (IP)
• Serves as the primary liaison with sponsors, IDS, and other parties as necessary
• Prepares for and provides support for study monitoring and audit visits
• Maintains participant level documentation for all studies
• Employ strategies to maintain retention rates
• Screens participants for complex studies
• Develops or helps develop SOPs
• Conducts activities for study visits in compliance with the protocol
• Prepares for, coordinates, and actively participates in site visits

• Writes, reviews, tests, and maintains code to support analytic dataset development and statistical analyses, ensuring accuracy, efficiency, and reproducibility.
• Implements data quality initiatives under the guidance of the Registry Lead to ensure accuracy, completeness, and reliability of datasets.
• Works closely with the Registry Lead to ensure timely completion of deliverables and adherence to project deadlines.
• Assists the Registry Lead in maintaining existing reports and developing new reports as needed.
• Produces monthly analytic data cuts, monthly reports, and quarterly reports, ensuring accuracy, consistency, and alignment with reporting requirements.
• Serves as an additional point of contact for assigned registries, proactively supporting colleagues by addressing registry-related questions on data structures, outputs, etc.
• Provides support on ad hoc projects and analyses as needed.
• Creates data pipelines for ingestion of external data sources and integration with clinical registry data to create combined datasets.
• Compiles, analyzes and reports statistical data for various projects.
• Carries out complex statistical analyses with supervision according to a statistical analysis plan.
• Assists Biostatistical Team Lead in the development of new statistical methodology for measurement and analysis of data.
• Assesses relevant literature as well as existing data, evaluates the quality of data used in reports and assists with preparation and distribution of periodic reports.
• Prepares written reports and summarizes data for investigators with minimal supervision.
• Makes original contributions to research projects, takes initiative in professional activities and beginning to be more independent in their statistical decision making.
• Closely collaborates and participates in knowledge sharing with other statistical analysts.

Biostatistician II

• 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

Biostatistician – Health Services Research

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer.
• Interprets data on complex issues and makes good business decisions with support from line management.
• Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations.
• Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
• Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
• Ensures efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up.
• Supports and ensures that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.
• Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

Senior Clinical Trial Manager – FSP

• Define and lead the global account development and inside sales strategy, aligned to CRG’s long-term commercial growth objectives.
• Drive enterprise-wide demand generation and pipeline acceleration strategies.
• Partner with divisional commercial leaders to unlock growth across key markets.
• Shape the evolution of CRG’s commercial model by integrating inside sales, digital channels, and advanced segmentation strategies.
• Own global performance against revenue pipeline, conversion, and productivity metrics.

Vice President, Account Development – Clinical Research Group

• Demonstrates understanding of the research and organizes work assignment to maintain the scheduled study times for appropriate research events
• Carries out major experimental protocol events including EKGs, phlebotomy, urine collection, standard measurements, vital signs, and blood pressures
• Demonstrates knowledge and skills interacting with human participants, investigators, and other research support personnel
• Sets up and monitors data collection equipment
• According to protocol, collects and processes biologic specimens, including blood, urine, and saliva
• Conducts standardized chemical and physical tests on experimental or clinical materials/specimens
• Administers written and computerized tests and completes study forms as necessary
• Assists in preparation and distribution of meals as scheduled in protocols and completes documentation as necessary
• Travels to other hospital departments as required conducting clinical research procedures
• Follows universal/standard precautions and maintains clean and safe work and subject areas, reports unsafe work areas to appropriate leadership
• Maintains the safety and wellbeing of participants at all times
• Demonstrates professionalism and respect for subject rights and individual needs

Clinical Research Technician

• Review and assess clinical data
• Translate complex data into clear insights
• Communicate clinical findings to teams and clients
• Support development of clinical study reports

Clinical Scientist – Oncology

• Recruits, interviews and obtains informed consent from prospective subjects for entrance into clinical trials and studies
• Coordinates appropriate laboratory tests and other procedures for subjects participating in studies; including drawing blood or collection of other samples
• Coordinates with Investigational Pharmacy for subjects to receive required drugs
• Communicates with Sponsored Programs Administration to ensure proper management of charges and billing
• Coordinates and submits IRB protocols, reports, revisions, updates, approvals
• Records appropriate clinical and laboratory data on forms provided by the principal investigator(s), federal government, and/or industry sponsors
• Communicates with study sponsors, federal agencies, principal investigators, and sub-investigators about research projects
• Provides resources for staff, patients, families, and community regarding research
• Travels to clinical research sites, hospitals, physician offices, and facilities within the System as necessary
• Performs other duties as assigned within department

• Compiles, analyzes, and reports statistical data for various projects
• Conducts complex statistical analyses with supervision in accordance with statistical analysis plans
• Supports the Biostatistical Team Lead in developing new statistical methodologies for data analysis
• Applies advanced statistical methods, which may include simulation models and other statistical programming, as needed
• Reviews relevant literature and existing data, assesses data quality, and demonstrates increasing independence in statistical decision-making
• Contributes to research projects and takes initiative in professional activities
• Closely collaborates and participates in knowledge sharing with other statistical analysts
• Utilizes various database management systems as required

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Senior Clinical Trial Manager

Clinical Trial Manager

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

Operations Finance Director – Clinical Research Central Laboratory

Senior Clinical Trial Manager – CNS

Associate Director, Clinical Research Lead – East Coast/Midwest

Clinical Research Nurse Coordinator

Senior Principal Biostatistician

Clinical Research Nurse

Clinical Research Coordinator

Clinical Trial Manager

Clinical Research Coordinator

Biostatistician II

Biostatistician – Health Services Research

Senior Clinical Trial Manager – FSP

Vice President, Account Development – Clinical Research Group

Clinical Research Technician

Clinical Scientist – Oncology

Clinical Research Nurse

Biostatistician II