Senior Clinical Research Associate - Pediatrics

Summary

The Multi-Site Coordinator is a cross functional role which is responsible for the coordination of all aspects of clinical trial team activities for assigned project(s). The MScoordinator plans, implements, coordinates, and manages multisite clinical research projects. The coordinator is responsible for managing and tracking all site's deliverables including regulatory approvals and essential documents. In addition, this position provides high-level program coordination related to promoting internal and external relationships, managing internal and external communications and meetings for assigned studies, tracking and evaluating research metrics, and developing and implementing standard operating procedures (SOPs).

Job Duties

• Works closely with assigned regulatory coordinator to track and accomplish deliverables. 
• Coordinates IRB applications to local/central IRB. Coordinates distribution of IRB-approved protocol and other documents to sites for editing and submission. Verifies completeness of IRB applications including the Informed consent for study sites. Creates and maintains records of IRB submissions, approvals, and expiration dates for all study sites  (e.g. in electronic clinical trial management system). Performs Activation checks and activates participating sites. Maintains status tracker for participating sites.
• Identifies and mitigates potential research compliance risks.
• Collects and maintains essential documents for participating sites. 
• Creates and maintains regulatory binders for participating sites. 
• Tracks SAE reporting and submits to parties involved as necessary.
• Tracks contract execution.
• Assists with protocol document amendment creation as assigned. Maintains a list of pending amendments.
• Assists with creation and submission of reports. 
• Create and distribute study newsletters.
• Assists with responses to monitoring and audit reports.
• Communicates with the coordinating center. Keeps study team abreast and keeps a log of latest developments and deadlines. Engages stakeholders and other relevant parties as needed. Monitors the progress of the project and regularly report to stakeholders.
• Develops and maintains a processing and tracking system for all communication. Evaluates and analyzes clinical research data as appropriate.  Works with PI and data manager to set-up database and data collection tools. Monitors data collection and submission of data from all sites.
• Assists in development of study Manual of Operations and training documents. Conduct training as assigned (e.g. SIV).  Establishes schedule of pre-study training conference calls.  Responsible for preparing for monitoring and auditing visits, and if applicable, reviewing reports from visits to other study sites.
• Communicates verbally and in writing as needed. Maintains contact with other institutions participating in the studies. Conducts scheduled conference calls, and if possible, in-person team meetings. Uses templates to post monthly reports to a central website, SharePoint, or distributed via email as needed. Distributes data summaries to investigators and coordinators at study sites; this may occur periodically throughout study or only at the end of data collection and analysis. Explains and interprets matters related to study.
• Coordinates study closeout activities at external sites.
• Effectively prioritizes and manages work activities. Works with team to ensure study time-points are met. Volunteers to assist team with overflow duties.
• Participates in protocol feasibility assessment and actively participates in protocol meetings including but not limited to investigator and site initiation meetings. Schedules study team meetings and maintains notes as assigned.
• Point of liaison between project team and management.
• Interacts with sponsors as required to facilitate protocol activities and maintain current study documents.  Collaborates with physician, mid-level practitioners, and research coordinators/nurses and data managers. 
• Provides assistance and training to lower level employees. Provides advice and input to the team.
• Continuously improves on processes and systems that requires understanding of several involved specialities.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Bachelor's/Master's degree in Business Administration, Health Administration or in a related field.
• Four years of clinical research work experience in the role of a study coordinator/regulatory coordinator/or similar.
• Requires excellent communication skills, both orally and in writing.
• Should have excellent time management and organization skills.
• Clinical research project management experience preferred.
• Should have a good knowledge of GCP, FDA and other applicable regulations governing the conduct of clinical trials.
• Working knowledge of clinical trial strategy and study design, statistical methods and data reporting is helpful.
• Should possess the ability to manage multiple projects.
• Requires familiarity with medical, clinical research and/or scientific terminology.
• Should be proficient in use of MS Office software packages; spreadsheet analysis/database analysis is helpful.
• SOCRA Clinical Research Professional or similar certification preferred.