Research Coordinator Jobs

About The Position

Requirements

• Master's degree plus 3 years of work experience in a clinical research setting
• Demonstrated experience managing preclinical translation and clinical studies and supervising others.
• Theoretical understanding of health sciences research and ICH-GCP guidelines, with experience applying policies and procedures.
• Skilled at technical documentation and scientific writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations.
• Experience in a complex medical or academic development setting.
• Excellent communication skills – both written and verbal.
• Comfortable interfacing with highest level of university leadership and university supporters/volunteers.
• Demonstrated affinity for diplomacy and the ability to cultivate and maintain relationships at all levels.
• Practices a high level of integrity and honesty in maintaining confidentiality.
• Ability to multi-task effectively and demonstrate strong organizational skills.
• Sound judgment and decision making.
• A cooperative and team-oriented attitude.
• Effective facilitator in various settings.
• Bachelor's degree in related field(s)
• Combined experience/education as substitute for minimum education
• 3 years in on-site clinical trial monitoring.
• Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting.
• Demonstrated experience managing and supervising others, using medical devices and terminology, and managing study records, finances and vendors.
• Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations.
• Ability to manage and prioritize different tasks and projects, with deft interpersonal skills for communicating with all levels of staff and various individuals and groups coordinating and executing study activities.

Nice To Haves

• Master's degree plus 5+ years of work experience in a clinical research setting
• Knowledge about or experience with the development of gene and cell therapies.
• Experience in data management, including data management systems and data analytics.
• Experience in regulatory affairs (pre-IND meetings, IND modules).
• Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s)
• Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
• 5 years of experience.
• Excellent written and verbal communication skills to express complex ideas to study staff at research and clinical institutions.
• Ability to handle several priorities within multiple, complex clinical trials.
• Strong understanding of current GCP guidelines applicable to the clinical research conduct.
• Proficient in OmniPlan or other timeline applications.
• Familiarity with academic medical centers.

Responsibilities

• Co-develops and drives agenda, the preparation of pre-clinical translation and clinical study protocols and reports on study status and identifies action items in multifunctional study team meetings.
• Participates in departmental initiatives aimed at improving process and efficiency.
• Attends project management meetings, providing overview of pre-clinical translation/clinical trial progress.
• Integrates, oversees and reports on information between staff and functional groups.
• Develops partnerships with internal and external groups with goal of increasing site performance and knowledge exchange.
• Acts as point of contact for programs and responds to or coordinates responses to information requests.
• Proactively anticipates and identifies operational, monitoring, and regulatory needs, ensuring early intervention when needed.
• Develops and implements standard operating procedures (SOP) and process improvements.
• Manages large, multi-site pre-clinical translation and clinical trial studies and teams.
• Assists in providing quality reviews of study conduct, protocols and data.
• Establishes and drives project timelines, monitors progress toward project goals and ensures study operations and documents are developed and implemented in compliance with FDA regulations and ICH-GCP guidelines.
• Conducts quality control reviews of protocols, study reports and associated documentation.
• Compiles project performance metrics, identifies problems through analysis, recommends corrective and preventive actions, and ensures their completion through internal and external audits.
• Stays abreast of current, relevant literature and clinical practice norms for project/program area(s), as well as any changes within legal, regulatory and technology environments which may affect SOP and any trial documentation and ensures alignment.
• Participates in marketing campaigns or events to promote programs.
• Coordinates distribution of program materials (e.g., newsletters, class notifications).
• Drafts and/or generates advanced communication items, and coordinates production (e.g., formatting, copying) and dissemination of documents (e.g., presentations, course handouts, grant proposals).
• Encourages a workplace culture where all employees are valued, value others and have the opportunity to contribute through their ideas, words and actions, in accordance with the USC Code of Ethics.

Benefits

• excellent benefits and perks