VISION:

Our Vision is to create a world-class health system to advance medicine and increase access for the communities we serve by empowering caregivers to heal through compassion, knowledge, innovation, integrated care and excellence.

POSITION SUMMARY:

This position will conduct, monitor, and coordinate large multi-center clinical trials in hospital and clinical settings. Responsibilities will be to ensure that the study Investigators adhere to FDA and protocol guidelines. Oversight of research activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects. Gather patient data specified in the study protocol and provide general administrative duties in support of the study. Serve as the main contact with study sponsors or site investigator on data management issues and activities.

POSITION EDUCATION/QUALIFICATIONS:

• Bachelor’s or Master’s degree with 2-5 year experience in the broad spectrum of clinical research and/or Qualified Clinical Research Certification.
• Basic Life Support Certification Required.
• Computer skills required with knowledge of Microsoft Office suite.
• Good written and verbal communication skills required.
• Some evening or weekend work will be required
• Bilingual – English/Spanish.

JOB KNOWLEDGE/EXPERIENCE:

• Two – five(2-5) years of related experience preferred
• Knowledge of randomized controlled trial principles, methodology, and procedures.
• Knowledge of all federal, state and joint commission regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
• Ability to evaluate judgments.
• Ability to analyze and evaluate clinical processes.
• Establish and maintain effective working relationships with physicians, staff members and patients.
• Ability to oversee clinical activities that relate to a large study or project.
• Knowledge of computer application software (Microsoft Office Suite).
• Knowledge of medical terminology.
• Possess excellent verbal and written communications skills in English and Spanish.
• Possess thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical trials.
• Ability to interact with Research staff and Physicians on a daily basis and overlook multi-center clinical trials.
• Ability to effectively manage time and prioritize workload.
• Excellent interpersonal skills; Problem-solving skills.
• Self-starter with the ability to work alone and as part of a team.

POSITION RESPONSIBILITES:

• Oversees the Clinical activities for a large complex study involving multiple sites.
• Ensures the adherence of controlled clinical trial protocols.
• Serves as liaison between the study Investigators, nurses, coordinators, pharmacists and assistance for numerous institutions.
• Provides performance management for staff.
• Accompany sponsor personnel on pre-site and clinical site initiation visits with the Principal Investigators.
• Obtain human subject consents.
• Accommodate sponsor personnel during monitoring visits.
• Ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulation, guidelines and policies.
• Ensure appropriate transmission of clinical case data to the sponsor data management centers.
• Reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
• Maintains process and tracking system of protocol related paperwork.
• Coordinates the maintenance of record on study medication and study devices dispensation and inventory usage during the course of the study.
• Ensures Confidentiality of subject records.
• Monitors and records patient response to treatment and communicates study data and results to investigators.
• Maintains and completes source documentation and oversees the preparation of study activity reports for sponsors and investigators as appropriate.
• Prepare regulatory and ethical submissions and procedures to the Institutional Review Boards and study sponsors.
• Implement the clinical trial from initiation through the stages of development documents, tools, organization of facilities and maintain current curriculum vitae and licenses.
• Responsible for the set-up and maintenance of the administrative structure and the infrastructure of the project(s).
• Responsible for the management of study budget.
• Establish and implement protocol Standards of Operations (SOP’s).
• Conduct the financial and contract negotiations at the appropriate management level.
• Negotiate contract terms, pricing and payment schedule, ensuring that the agreements with the vendors/suppliers are commercially advantageous.
• Other duties as assigned.

LINES OF REPSONSIBILITES:

(Chain-of-command)