Clinical Research

• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.

Principal Biostatistician, RWE – PASS Experience

• Responsible for the timely and accurate preparation and maintenance of budget templates for sponsored clinical trials
• Review of New Study routing forms and essential study start-up documents
• Itemized cost analysis and interpretation of clinical protocols into budgets milestones
• Provide accurate patient cost descriptions for the ICF to be submitted to the IRB
• Update budget, milestones, and ICF information as necessary per contract/protocol amendments
• Manage large volume workflow across multiple research programs

Clinical Research Budgeting Analyst – Clinical Trials

• Support Omada’s research program by coordinating day‑to‑day study operations for assigned protocols, including tracking enrollment targets, participant flow, and key milestones.
• Contact study participants to facilitate timely, complete and accurate participation in study.
• Respond to questions and requests from research participants, escalating complex or clinical issues to the appropriate team member per protocol.
• Coordinate transfer of data between company and collaborating institutions, following data‑handling and privacy procedures.
• Maintain accurate study documentation and trackers (e.g., enrollment logs, contact logs, data transfer records) so the team has a current view of study status.
• Monitor day‑to‑day study progress, proactively flag risks to timelines or data quality, and recommend practical options to keep the work on track.
• Participate in regular study team meetings and status reviews, providing clear updates on your assigned workstreams and dependencies.

Clinical Research Coordinator

• Assist in recruitment, engagement and collaboration with local oncology clinics participating in the study
• Support regulatory submissions, including IRB and Oncore
• Coordinate logistics for site visits and for conducting qualitative interviews/focus groups with key informants at each site
• Clean, transcribe, and organize qualitative interview and focus groups data
• Participate in regular team meetings to discuss progress and updates locally and with other sites
• Track and manage data receipt from study sites, including proactive follow-up to ensure timely submission
• Assist in developing, organizing, and maintaining systems for data collection across clinical sites
• Assist with training clinical teams on smoking cessation program and clinical workflow
• Perform other duties as assigned to support the smooth execution of the study

Clinical Research Coordinator I – Psychiatry

• Performs a variety of research, database, and clerical duties of a routine and technical nature in support of clinical research
• Coordinates administration, management, participant recruitment, and collection of behavioral and neuroimaging data for research studies
• Maintains and updates site demographics on computer database
• Logs forms received and file as appropriate
• Prepares reports from database to include weekly reports and other reports as requested
• Receives and disseminates study-related regulatory documents and correspondence
• Assists in screening documents for completeness and compliance with protocol and appropriate regulations
• Investigates incomplete, inaccurate or missing documents to ensure accuracy and completeness of data
• Communicates and coordinates with study personnel as required
• Attends routine meetings and other meetings related to clinical research

Clinical Research Study Assistant I – Radiology

• Assist investigators in coordinating clinical research studies focused on Epilepsy and rare pediatric diseases
• Implement and manage all phases of study/protocol; ensure compliance with protocol guidelines and regulatory agency requirements
• Establish record-keeping systems; assess and determine participants’ progress in the study
• Analyze, investigate, and report adverse events; make relevant decisions regarding participant inclusion
• Serve as liaison with funding or sponsoring agency; recruit and enroll study participants
• Explain purpose of study and obtain informed consent packets from participants
• Administer/tests lab and clinical assessments to ensure timely completion of protocol requirements
• Evaluate and interpret collected clinical data; prepare oral or written presentations or reports

Clinical Research Coordinator I – Neurology

• Participates in the recruitment of study participants as identified in related protocol
• Visits with study participants to explain study, screens for eligibility and obtains informed consent of participants
• Completes all necessary paperwork/documentation according to study protocol
• Performs basic/scripted assessments to confirm eligibility to participate in study
• Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources
• Prepares and distributes study packets and information

Clinical Research Study Assistant II – Neurology

• Serve as study clinical scientist on oncology cell therapy trials
• Partner closely with Senior Medical Director in the execution of the clinical development strategy
• Actively participate in study start-up activities, asset team meetings, safety monitoring committees
• Coordinate patient enrollment and dosing with product manufacturing/delivery
• Conduct review of emerging clinical and medical data to ensure quality data
• Collaborate on the preparation and review of clinical protocols and amendments
• Support the development of other critical study and regulatory documents
• Support clinical development activities during implementation of clinical database with CRO
• Review risks, query resolution, and protocol deviations
• Develop effective collaborations with key internal and external partners

Clinical Scientist

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Independently develop study timelines, key deliverables, and risk/mitigation strategies
• Lead selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
• Plan and lead study team meetings
• Lead the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets)
• Contribute to the content and review of study documents (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, product administration guidelines)
• Track and ensure optimization of site startup activities and activation, subject enrollment, data collection, and trial closeout
• Ensure accurate and timely execution of site visit monitoring reports
• Identify, select, and monitor performance of sites
• Negotiate and manage the budgets and payments for sites
• Develop and maintain strong working relationships with study investigators and site staff
• Manage investigational product release packages and investigational product accountability
• Coordinate with Clinical Supply Chain Operations regarding investigational product shipment to sites
• Oversee the Trial Master File according to ICH- GCP and SOPs
• May assist in clinical data review and query generation
• Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
• Actively participate in and contribute to the development of department initiatives aimed at improving efficiency and best practices

Senior Clinical Trial Manager

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines
• Leads specific aspects of assigned clinical trial(s)
• Supports selection and performance management of CROs and other ancillary vendors
• Tracks and ensures optimization of site startup activities and activation
• Contributes to the content and review of trial materials
• Coordinates, files and tracks the distribution of study documents
• Assists in the set up and oversight of the Trial Master File
• Ensures all trial documentation is in a state of audit readiness
• Identifies, selects, and monitors performance of investigational sites
• Ensures accurate and timely site visit monitoring reports
• Develops and maintains strong working relationships with trial investigators and staff
• Assists in management of budgets and payments for investigative sites
• Coordinates with Clinical Supply Chain Operations regarding investigational product shipment

Associate Clinical Trial Manager

• Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations
• Independently developing the trial’s timelines, budgets, key deliverables, and risk/mitigation strategies
• Leading the development of trial materials (e.g., protocol, informed consent forms, CRF)
• Planning and leading study team meetings
• Managing, mentoring, and training clinical operational staff
• Leading the identification and engagement of CROs and other third-party study vendors

Clinical Trial Manager

• Assists in developing plans for research projects and discusses the interpretation of results
• Collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies
• Assists in the preparation of amendments to protocols and/or modifications to study design as appropriate
• Coordinates the development of forms, questionnaires and the application of research techniques
• Assists in writing instructional procedure manuals for study progress, data collection and coding
• Reviews journals, abstracts and scientific literature to keep abreast of new developments
• Implements and manages all phases of study/protocol and ensures compliance with protocol guidelines
• Evaluates and interprets collected clinical data and prepares oral or written presentations or reports

Clinical Research Coordinator II – Medical Oncology

• Assists investigators as coordinator of a basic to moderately complex clinical research study
• May be responsible for multiple research studies simultaneously
• Acting as a liaison with the school, sponsoring agency, community and study participants
• Responsible for managing and recording all phases of study protocol as required by the sponsoring agency
• Provides updates, understands study protocols, and collects patient data and information
• Performs clinical tasks including ECGs, collecting blood samples, and setting patients up with Holter monitors
• Active in recruiting study patients, managing study data collection, and performing clinical tasks related to the study

Clinical Research Coordinator I – Nephrology

• Participate in the recruitment of study participants as identified in related protocol
• Visit with study participants to explain study, screens for eligibility, and obtains informed consent of participants
• Complete all necessary paperwork/documentation according to study protocol
• Collect data from study participants, medical records, interviews, questionnaires, diagnostic tests, and other sources
• Perform basic evaluations and interpretation of collected data and prepares appropriate reports and documentation as necessary

See all jobs on JobTailor

Principal Biostatistician, RWE – PASS Experience

Clinical Research Budgeting Analyst – Clinical Trials

Clinical Research Coordinator

Clinical Research Coordinator I – Psychiatry

Clinical Research Study Assistant I – Radiology

Clinical Research Coordinator I – Neurology

Clinical Research Study Assistant II – Neurology

Clinical Scientist

Senior Clinical Trial Manager

Associate Clinical Trial Manager

Clinical Trial Manager

Clinical Research Coordinator II – Medical Oncology

Clinical Research Coordinator I – Nephrology

Clinical Research Study Assistant II – Neurology