Clinical Research

• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies.
• Responsibilities may include but are not limited to:
• - Screening of patients for study enrollment;
• - Patient consents;
• - Patient follow-up visits;
• - Documenting in source clinic charts;
• - Entering data in EDC and answering queries;
• - Obtaining vital signs and ECGs;
• - May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• - Requesting and tracking medical record requests;
• - Updating and maintaining logs, chart filings;
• - Maintaining & ordering study specific supplies;
• - Scheduling subjects for study visits and conducts appointment reminders;
• - Building/updating source as needed;
• - Conducting monitoring visits and resolves issues as needed in a timely manner;
• - Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• - Filing SAE/Deviation reports to Sponsor and IRB as needed;
• - Documenting and reporting adverse events;
• - Reporting non-compliance to appropriate staff in a timely manner;
• - Maintaining positive and effective communication with clients and team members;
• - Always practicing ALCOAC principles with all documentation;
• - Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• - Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• - Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
• - Assist with training of new research assistants and coordinators;
• - Assist with scheduling and planning for visit capacity for assigned studies;
• - May set up, train and maintain all technology needed for studies;
• - May assist with study recruitment, patient enrollment, and tracking as needed;
• - May handle more complex study assignments and volumes;
• - May participate in community outreach/education events;
• - Maintaining confidentiality of patients, customers and company information, and;
• - Performing all other duties as requested or assigned.

Travel Clinical Research Coordinator

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Collaborate with physician-scientists, investigators, and research leadership to develop clinical trial and research protocols from concept papers and letters of intent through final protocol submission.
• Draft, edit, and manage protocol documents, informed consent forms, study procedures, and supporting regulatory documentation.
• Coordinate protocol development activities across study teams, participating sites, and external partners.
• Assist investigators in resolving complex protocol development, regulatory, operational, and submission-related challenges.
• Support protocol submissions and amendments for Institutional Review Boards (IRBs), VA review processes, commercial IRBs, FDA submissions, and other regulatory entities.
• Support preparation and coordination of Investigational New Drug (IND) applications and related FDA communications.
• Assist with development and execution of Cooperative Research and Development Agreements (CRADAs) and coordination with the Office of General Counsel and industry partners as needed.
• Coordinate study startup activities and support compliance with protocol requirements, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory standards.
• Track protocol development timelines, milestones, approvals, and deliverables across multiple concurrent studies.
• Facilitate communication among investigators, clinical research staff, regulatory personnel, sponsors, and participating study sites.
• Develop protocol templates, guidance documents, and process improvements to support research operations and protocol development efficiency.
• Monitor progress and identify risks that could impact protocol development timelines or regulatory submissions.

Clinical Research Protocol Specialist

• 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.

Clinical Research jobs in Virginia

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