Responsible for the implementation and support of clinical trials under the auspices of Envision Research LLC, a division of BRF.

ESSENTIAL FUNCTIONS

Responsibilities include but not limited to:

Coordinate daily clinical research activities according to the organization’s SOPs, study protocols, GCP and FDA/ICH guidelines and assist Principal Investigators in planning, development and execution of clinical trials.

Complete and maintain regulatory documents required by various regulatory and sponsor entities.

Serve as the lead contact for study sponsors, governmental agencies, Institutional Review Boards, participating physicians, hospital departments, research staff and patients. Respond to queries in a timely manner.

Promote Physician relations for clinical research collaborations. Communicate regularly with physician practices for patient referrals.

Provide on-site services and protocol-specific training to research and clinic staff.

Provide ongoing monitoring of study procedures, schedule and conduct study visits according to study protocols.

Communicate with study participants to obtain and maintain informed consent and ensure compliance with study protocol schedules. Provide education to study participants to ensure understanding of proper medication dosage, administration and treatment.

Meet/exceed patient enrollment goals while ensuring quality of collected data. Participate in recruitment and selection of medical study participants by interviewing and reviewing medical history, questionnaires and lab results to determine compliance with eligibility requirements.

Complete case report forms and maintain source documentation per GCP guidelines. Create entries and update research databases. Prepare progress reports and work with Investigators to report serious adverse events; dispensing and accountability of Investigational product.

Maintain inventory level of all supplies and equipment.

Perform regular internal audits of study records for quality assurance. Facilitate, coordinate and release research SOPs and guidelines.

Obtain blood samples, vitals, and other testing as needed for clinical research studies.

Assist Business Manager with the review of study-specific financial reports, including study participant billing, to ensure billing compliance. Assist with budget coverage analysis and budget analysis forms according to study protocol procedures.

Attend Investigator meetings and clinical research training conferences.

Other duties as assigned.

MINIMUM QUALIFICATIONS AND EDUCATION REQUIREMENTS

Bachelor of Science and Associate degree in Nursing, Bachelor of Science in Nursing, or an equivalent combination of education and experience in clinical trials required. Expertise with GCP and FDA/ICH regulations, clinical trials and clinical work in healthcare is preferred. Certification as a Clinical Research Coordinator desirable. Experience in conducting clinical trials for Community Physician Practices a plus.

REQUIRED KNOWLEDGE SKILLS AND ABILITIES

Excellent communication skills.

Demonstrate excellent organizational skills including attention to detail.

Customer service oriented and possess a team player attitude.

Able to handle effectively and efficiently multiple tasks concurrently and adapt to changes in responsibilities and workloads.

Work and think independently; use sound judgment to solve problems.

Possess a high degree of urgency and self-motivation, work ethic, integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other related information. Utilize proficiently computers and software, such as Microsoft Word, Excel, and Outlook.

Utilize effectively standard office equipment such as phone, photocopier, scanner, and fax machine.

Basic Life Support (CPR) Certification is a plus.

Individuals must possess these knowledge, skills and abilities or be able to explain and demonstrate that the individual can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of skills or abilities and to possess the necessary physical requirements with or without the aid of mechanical devices to safely perform the essential functions of the job.