Clinical research manager [h1.location_city]

Description

The RN, Clinical Research executes and coordinates daily clinical research activities according to GCP and FDA / ICH guidelines; reviews and assists in the selection of Sponsor supported clinical trials; completes and organizes all IRB / Sponsor regulatory documents; negotiates clinical trial budgets and invoices for site activities; ensures IRB approved protocols are implemented and followed; educates patients and their families about clinical trial treatments and possible side effects; executes and documents the informed consent process and monitors patient status and safety; collects, organizes and reports research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; conducts visits with CRA's (Clinical Research Associates) to initiate protocols and to verify source documents; maintains investigational product inventory and oversees the dispensing of investigational product to patients; reports regularly to the Principle Investigator on the status of all open clinical trials under his / her supervision. Works closely with the laboratory to ensure samples are collect and processed according to protocol.

A $5,000 sign-on bonus is available for eligible new hires-$2,500 paid on the first paycheck after hire and $2,500 paid after one year of continuous employment.

JOB SPECIFIC DUTIES AND RESPONSIBILITIES :

• Under direct supervision of a physician and nurse (if applicable), is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.
• Collaborates with physicians in determining eligibility of patients for clinical trials.
• Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
• Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
• Maintains regulatory documents in accordance with SOPs and applicable regulations.
• Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
• Additional responsibilities may include working directly with other research bases and / or sponsors.
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
• Interacts with the Clinical Trial Sponsors to recruit new clinical trials for the site. In collaboration with the Principal Investigator, conducts feasibility questionnaires and participates in site selection process.
• Negotiates the clinical trial budget with the Sponsor and invoices for the completed site activities.
• Order and maintain inventory of all study specific supplies including recruitment materials and specific lab kits.
• Collect, process and ship all study defined lab kits to the Central Lab as directed by the sponsor.

OTHER JOB REQUIREMENTS : Occasional travel to satellite clinics.

EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION :

Bachelor's degree, preferred.

EXPERIENCE, KNOWLEDGE, SKILLS and ABILITIES :

REASONING ABILITY :

INTERPERSONAL SKILLS :

PHYSICAL DEMANDS :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

WORK ENVIRONMENT :

The work environment described here are representative of those an employee encounters while performing the essential functions of this job. This position involves potential exposure to infectious diseases. Colleagues are offered appropriate vaccinations and safety training.

COMMENTS :

This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of the job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

SAFETY SENSITIVE

This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.