Job Description

Statement of Work Details

Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).

Collects research data and prepares information for inputs and analysis.

• Verify study participant information and collect data and results of testing.
• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
• Set up, format and enter data into spreadsheets to analyze information and create reports.

Supports the development of forms and questionnaires.

• Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.
• Assist researchers develop, maintain and complete study data collection forms and source documents.
• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.

Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.
• Assist researchers with the collection and analysis of research data and samples.
• Assess eligibility for study participation as defined by inclusion and exclusion criteria.

Monitors subject's progress and reports adverse events.

• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
• Update and maintain logs and records of patient and family contacts.
• Provide continuity of care to patients enrolled on assigned protocols.

Supports assembly, development and review of new research projects.

• Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Assist researchers obtain IRB approval before any study related activities begin.
• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Assist researchers develop and maintain current and new research protocols.

Supports the creation and management of clinical websites and web-based tools.

• Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.

Organizes and performs clinical research, utilizing internet and other available clinical resources.

• Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.- Maintain and organize an online resource of documentation regarding clinical trials, including Standard Operating Procedure documents for all tasks related to the handling of clinical trials.
• Administer and coordinate study protocols and clinical trials of depression, bipolar disorder and suicide risk, including all research activities and interventions.

Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

• Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices.
• Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
• Assist staff on all facets of clinical studies including subject enrolment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
• Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.
• Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits.

Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Prepare and submit for review accurate source documents related to all research procedures.
• Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.
• Develop and maintain research protocol documentation and operations.

Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.

• Participate in all study-related IRB and regulatory matters, including reporting requirements, protocol deviations, unanticipated problems, and adverse events.
• Ensure protocol integrity by coordinating and monitoring all aspects of study procedures.

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