Clin Research Data Spec II

Opening

Full Time 40 hours Range URG 107 Medicine SMH Pulmonary

Schedule

8 AM-4:30 PM

Responsibilities

GENERAL PURPOSE:

Assumes responsibility for the data management of clinical research protocols. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates and organizes data entry plans to manage assigned caseloads. Responsible for the compilation, registration, and submission of data, monitoring compliance with the protocol, project management, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate, and compliant data reporting. Develops, implements, and evaluates recruitment strategies, information, data, and study management systems. Assists PIs and research staff with recruitment efforts regarding industry sponsored, NIH, and Investigator Initiated studies.

RESPONSIBILITIES:
Data Management:
Assists in creating, updating, and maintaining all project documents. Developing timeline to meet specific aims of project, scheduling, leading, and creating agendas for study meetings, supervision and direction of data collection, coordinating and obtaining required datasets, including requesting DUAs or other legal documents as required, coordinating data management activities with data manager and data scientist, assisting in manuscript preparations and submissions, annual reporting, budget monitoring and reporting. Enters data accurately from Source documents (Paper or Electronic) into electronic case report forms on Study assigned databases. Coordinates with the investigator to ensure data accuracy. Manages a workload of studies commensurate to level of experience. Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study. Assist with documentation and tracking of training completed for matters related to open and pending studies. Prepare factual reports and provide data for staff reports as needed. Ensure the integrity and security of study data . Meets with the staff to discuss trends/discrepancies in provided source documentation. Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed following each monitoring visit. Assists with regulatory processes as needed and in support of Sr. Clinical Research Specialist.

Quality assurance/management of Data:

Assists with the development and implementation of monitoring systems and methods to ensure quality, safety, efficiency, and consistency in processing human subject research data. Contribute to the design of the study protocol processes including assisting with the development and maintenance of standard operating procedures. Conducts quality checks and prepares documents for external monitoring visits. Assist with communication with sponsors when data correction is required. Monitoring and implementing change as needed throughout the study specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Subject Safety Reporting :
Develops reports and data clarifications (i.e. data queries) for each study. Under the guidance of the PI, answer more complex data clarifications (i.e., data queries) for each study. Ensures compliance in the reporting of subject adverse events (AE), medical events of special interest (MESI), and serious adverse events (SAE) and filing of these promptly to sponsors and IRBs.

Recruitment/Dissemination:

Assist the site in the development of methods and outcome reporting to improve and monitor the awareness and enrollment of volunteers in the Lung cancer screening trials. This includes assisting in the development of culturally relevant pamphlets, flyers, videos, and other recruitment and reporting tools to the target populations. Support relationships with community agencies and maintaining a presence in the community through attending relevant workshops and community activities. Keep consistently abreast of new innovative measures that are being used to recruit via multiple media sources, mobile devices, and social networks and report on its effectiveness. Maintain website and links with other sites to improve site¿s outreach capabilities. Develops, implements and evaluates recruitment strategies, information, data and reporting systems and study management systems. Assists in the dissemination of study results through study meetings, publications, and conference presentations

Grants:

Assists with grant preparation including develop and maintain timelines for projects, provide regular project updates for the Principal Investigator and submit required progress reports to the funding agency when necessary. Maintains IRB Documentation, develops and implements project strategy

Other duties as assigned

QUALIFICATIONS:

Required:

• Bachelor's degree
• And 1 year of relevant experience.
• Or equivalent combination of education and experience required

Preferred:

• Skill in completing assignments accurately and with attention to detail required
• Ability to understand and follow standard research protocols and procedures required
• Ability to process and handle confidential information with discretion required
• Commitment to the University's core values required
• Ability to work independently and/or in a collaborative environment required
• Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
• Strong interpersonal, communication, and organizational skills required
• Highly collaborative, works well in teams required
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University¿s mission to Learn, Discover, Heal, Create ¿ and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $47,972 - $67,161 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.