Research Assoc I - SMB Research - Variable Shift - Part Time 0.6FTE

Sharp HealthCare•San Diego, CA

3d•Onsite

About The Position

Under supervision, assists in the coordination of multiple clinical research studies involving human subjects from initiation to completion for a variety of clinical research studies at the Neonatal Research Institute. Functions as a study participant advocate preparing correspondence to sponsors and Sharp HealthCare Institutional Review Board (IRB).

Requirements

AHA Basic Life Support for Healthcare Professional (AHA BLS Healthcare) - American Heart Association -REQUIRED

Nice To Haves

Bachelor's Degree
1 Year experience in area of research.
Certified Clinical Research Coordinator (CCRC-ACRP) - The Association of Clinical Research Professionals -PREFERRED
Knowledge of subject recruitment, screening and evaluation of subjects and protocols.
Knowledge of regulatory requirements and documentation.
May be required to work variable hours and travel as needed.

Responsibilities

Act as a department liaison
Establishes and maintains productive partnerships with key sponsors, internal and external customers to achieve positive outcomes.
Uses sensitive and tactful skills interviewing study participants.
Builds on-going relationships with study participants to ease entry/access to the information needed.
Communicates in a timely manner with sponsors, monitors and PI to ensure study materials are in appropriate order.
Contributes to research program development, coordination, and management
Assists with the development of study specific tools to monitor protocol processes.
Actively adapts the use of study specific tools into daily practice.
Participates in team program development, coordination, and management.
Participates in research team meetings.
Contributes program development concepts to study coordinator and/or research committee.
Participates in ortho/neuro staff meetings.
Data collection and documentation
Submits new protocols to IRB following the Sharp HealthCare IRB guidelines.
Continued regulatory document update and communication (e.g. safety reports, annual reviews, and serious adverse events).
Communication to investigator(s) and sponsor of study status and patient enrollment.
Prioritizes work by monitoring incomplete/complete data, recheck process, correspondence requests and overall support for Research Study Coordinator.
Maintains and updates CV's and licensures independently.
Filing documentation in an accurate and timely manner.
Assists with the maintenance of financial database submitting to Finance Department by the fifth of each month.
Maintains financial database.
Prepares accurate and current invoices to sponsor.
Assists with timely payment of Shared Service account and care providers.
Documentation
Monitors/tracks all studies to assure that all clinical data is complete.
Collects data from study participants using a variety of methods, (telephone, interview, chart abstraction, electronic files).
Enters data into source documents, CRF, and electronic files as required by study.
Collects data in a meticulous, accurate and timely manner.
Evaluates the integrity/accuracy of the data ensuring.
Addresses identified problems in a timely manner.
Identifies opportunities to improve data quality and collection processes.
Communicates updates regarding data regularly.
Maintains current and accurate study logs.
Assures that all information is adequately and accurately prepared for monitoring visits.