Clinical Research Data Spec I

Opening

Full Time 40 hours Range URG 106 Medicine M&D-Infect Dis Unit

Schedule

8 AM-4:30 PM

Responsibilities

GENERAL PURPOSE:
The position is to join a dynamic and very busy research clinic with contracts with the NIH as well as pharmaceutical companies. Studies currently being conducted include RSV, Influenza, Human Metapneumovirus, and other respiratory and infectious diseases in adult populations.

JOB DUTIES AND RESPONSIBILITIES:

Data Management:

Assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Enters data accurately from Source documents (Paper or Electronic) into electronic case report forms on Study assigned databases. Coordinates with the primary and sub-investigators to ensure data accuracy. Manages a workload of studies commensurate to level of experience. Answers simple data clarifications (i.e. data queries) for each study. Under the guidance of the PI's and Research Nurses, answers more complex data clarifications (i.e., data queries) for each study. 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. Ensure compliance in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs. 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.

Quality assurance/management:

Assists Quality Manager 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.
Recruitment:
Assist the site in the development of methods to improve awareness and enrollment of volunteers in the IDRC trials. This includes assisting in the development of culturally relevant pamphlets, flyers, videos, and other recruitment 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. Maintain website and links with other sites to improve site's outreach capabilities.

Outreach:

Contribute to team efforts in identifying key leaders in the community, create or foster opportunities to partner with local community-based organizations; church groups neighborhood agencies, businesses, etc. to increase awareness and to increase participation at the research site. Serve as a promotional recruiter for the VTEU/IDRC. Support programs to create interest and increase knowledge in the community around the research. Assist in developing workshops in conjunction with the IDRC staff to small groups of individuals, church groups, college organizations and community groups to explain the goals of the IDRC and increase awareness of the responsibilities and commitment of volunteers in a IDRC studies. Contribute to the development of activities to increase levels of "trust" in target populations to decrease barriers and ultimately increase participation in research studies. This may entail partnering with area organizations to provide a unified message to the community at major events or health fair etc. Help facilitate community collaborations for major events.

QUALIFICATIONS:

• Associate degree required.
• Bachelor's Degree preferred.

• And 1-year experience required.
• Or equivalent combination of education and experience required.

• Skill in completing assignments accurately and with attention to detail 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 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.
• Ability to understand and follow standard research protocols and procedures preferred.
• Knowledge of medical terminology preferred.

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: $21.36 - $29.90 Hourly

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.