Human Subject Res Coord II

GENERAL PURPOSE:Coordinates the activities associated with human subject research and data management for the Geriatric Hematology/Oncology research group¿s studies.RESPONSIBILITIES:

Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies. Supports the contacts and relationships between and among Principal Investigator (PI), research staff, study sites and sponsoring and regulatory agencies.

Ensures compliance with all applicable regulatory and institutional requirements and standards. Ensures the integrity and security of all study data at all times. Initiates, monitors and ensures that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified.

Writes and submits protocols to be submitted to the IRB. Prepares and creates all other study materials: consent forms, other study materials

Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history to verify inclusion criteria are met before enrollment. May travel to the various regional sites for recruitment.

Manages ongoing studies. Develops workflows, oversees study procedures, manages study participants, develops and maintains recruitment flowcharts, maintains study files per SOP, protocol, and site instructions.

Builds and manages REDCap clinical database, manages REDCap study databases, performs quality checks across all databases.

Performs qualitative data analyses and analyzes data for novel research findings. Works with statisticians to compile and clean study data.

Writes and edits scientific manuscripts for journal submission. Creates figures from study data, prepares manuscripts for submission, writes and submits abstracts, presents study findings at conferences, performs systematic and literature reviews.

Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Trains/onboards human subject research coordinators to perform the following clinical assessments, but not limited to: SPPB, MOCA, Mini-Cog, BLESSED, Lawton IADL. Trains coordinators on the following software: MAXQDA, REDCap, SAS, Adobe Acrobat Pro. Mentors human subject research coordinators.

Acts as liaison with Sponsor¿s Monitor: to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator, and to ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review. Communicates with Sponsor to clarify data queries to determine report format.

Other duties as assigned.QUALIFICATIONS:

Bachelor¿s degree required

2 years of experience in human subject research coordination required or equivalent combination of education and experience required

Experience as Phlebotomist preferred

Knowledge of word processing and data analysis software required

SOCRA ¿ Certification in Clinical research upon hire preferred

Association of Clinical research Professionals (ACRP) upon hire 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 ApplyAll applicants must apply online.EOE Minorities/Females/Protected Veterans/DisabledPay RangePay Range: $51,810 - $72,534 AnnuallyThe 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.Apply for Job

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Location: School of Medicine & Dentistry

Full/Part Time: Full-Time

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