Clinical Research Coordinator

Role Overview

• Maintain records of study activity including databases, medical records, and if required, drug dispensation records and regulatory forms.
• Assess eligibility of potential subjects through methods such as phone interviews, review of medical records, discussions with physicians and nurses and the weekly ART meeting.
• Oversee subject enrollment to ensure that informed consent is properly obtained, documented and scanned into the patient EMR.
• Monitor study activities to ensure compliance with protocols and with all relevant institutional policies.
• Identify protocol problems or subject complaints, inform Senior Clinical Research Coordinator and assist in problem resolution.
• Prepare study-related documentation, such as Institutional Review Board submissions, protocol flow sheets, procedural manuals, adverse event reports, and progress reports.
• Liaison with the Institutional Review Board as needed and forward any needed information.
• Track enrollment status of subjects and document withdrawal information such as dropout causes.
• Coordinate sample collection processes, including patient compliance and communication flow between CCRM, FLC and FG.
• Assist the Scientific Director with final study reports, data analysis and manuscript preparation.
• Other duties as assigned.

Requirements

• Medical Assistant Certification or LPN licensure.
• Graduate of an accredited Medical Assistant School or Graduate of an accredited LPN Program.
• Minimum of 2 years of previous medical/research related experience.
• Must have excellent computer skills and excellent problem solving skills.
• Must be able to appropriately screen research participants for studies.
• Strong computer skills, ability to use basic office equipment.
• Strong ability to follow procedures and protocols is essential.
• Must be organized with a strong ability to multi-task, prioritize, have strong attention to detail, and have a strong ability to utilize time efficiently.
• Must have a strong ability to act independently as well as be able to work effectively in a team.
• Must have excellent customer service skills, exhibiting courteous, compassionate, and respectful treatment of internal and external customers at all times.
• Must consistently display a positive attitude and flexibility in changing situations.
• Must have excellent communication skills and make it a priority to consistently communicate positively and professionally with all staff members, physicians and patients.
• Must demonstrate the ability to be a team player and possess a willingness to perform duties that are assigned or delegated in a timely manner.
• Participate in identifying problems and suggesting solutions.
• Maintain confidentiality of all work information.
• Maintain strict confidentiality for all patient and clinic information, consistent with established security and confidentiality policies and HIPAA regulation at all times.
• Understand and assess for domestic violence and child abuse issues and reporting responsibilities.
• Will report concerns to Medical Director or Nurse Manager.
• Ability to work weekends when needed to meet with patients regarding studies.