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

• 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

• Assists investigators as coordinator of clinical research studies
• Manages and records study protocol phases
• Performs clinical tasks including ECGs and blood sample collection
• Recruits study patients and manages data collection
• Analyzes clinical data and prepares reports

Clinical Research Coordinator I – Nephrology

• Responsible for coordinating components of project plans.
• Makes decisions regarding planning and implementation of project plans.
• Assists with regulatory requirements and reporting.
• Develops study protocols, data collection instruments, recruitment materials, and other research forms.
• Collects, manages, and supports analysis of qualitative and quantitative data.
• Recruits and retains project participants.
• Collaborates with clinical partners in protocol development and implementation.
• Disseminates project findings: prepares summaries, presents at scientific conferences, and participates in manuscript preparation.
• Contributes to major sections or develops whole products as a result of project plans.
• Hires, oversees, and provides daily management and guidance for research assistants and other research staff.
• Maintains regular communication with PI, project consultants, and investigators.
• Performs other duties as assigned.

Clinical Research Coordinator II – School of Public Health

• 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

• Conduct and coordinate all aspects of clinical trial activities at the site.
• Perform phlebotomy on patients, following proper clinical and safety protocols.
• Recruit, screen, and enroll study participants according to inclusion/exclusion criteria.
• Schedule and conduct study visits, ensuring adherence to protocol requirements.
• Accurately collect, process, and ship biological samples per study-specific guidelines.
• Complete and maintain study documentation, including source documents, regulatory binders, and informed consent forms.
• Perform timely and accurate data entry into electronic data capture systems (EDC).
• Communicate effectively with sponsors, monitors, and other research team members.
• Ensure compliance with GCP, ICH, FDA, and IRB regulations.
• Assist in monitoring visits and audit preparation as needed.

Clinical Research Coordinator

• Support Safety Analytics with ADaM /TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables
• Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display
• Provide ADaM /TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries
• Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Senior Clinical Pharmacology/Biopharmaceutical Biostatistician

• 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

• 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

Clinical Research Source Development Coordinator

Principal Biostatistician, RWE – PASS Experience

Clinical Research Coordinator I – Nephrology

Clinical Research Coordinator II – School of Public Health

Clinical Research Patient Recruiter

Clinical Research Coordinator

Senior Clinical Pharmacology/Biopharmaceutical Biostatistician

Clinical Research Coordinator I – Nephrology

Clinical Research Study Assistant II – Neurology