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

• 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.

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Travel Clinical Research Coordinator

Clinical Research Source Development Coordinator