We are searching for an experienced Clinical Research Coordinator team. This position is full time with full benefits, 401K, seven (7) paid holidays, quarterly bonus program, (PTO) Paid Time Off, and flexible scheduling. They will work as an integral member of the staff maintaining the day-to-day relationship with patients and assist in the development of the network. This includes planning, coordinating and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work, Sponsor, CRO, and ACR SOP’s and any relevant local guidelines and regulations. The Clinical Research Coordinator will plan, direct, or coordinated clinical research projects. In addition, they will be expected to direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives.
· Work directly at patient/subject interface at research sites (multiple location) to deliver high quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.
· Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings.
· Assist with screening and enrollment of subjects into assigned studies.
· Support subjects on trials to encourage maximum retention and future recruitment.
· Assist with the establishment of a recruitment and contingency plan for each study.
· Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with state/federal requirements.
· Accurately complete source documents and case report forms in both paper and electronic format.
· Assist investigator with recording and reporting of adverse events and SAE’s as per local regulatory authority guidelines.
· Communicate effectively across all departments company-wide providing information by telephone, in written form, e-mail, or in person.
· Some local travel to ISN sites is required
Required Knowledge, Skills and Abilities:
- · Sound knowledge of medical terminology
- · Sound knowledge of ICH/GCP and Regulatory requirements.
- · Excellent interpersonal and organizational skills.
- · Proficient in the use of Microsoft Office and Excel.
- · Fluent in English, spoken and written.
- · Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
- · Ability to maintain confidentiality.
- · Phlebotomy experience. IV certified a plus.
- · Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Minimum Required Education, Experience, and Certifications:
- · Licensed RN or Paramedic Preferred
- · Maintain License/Certification status of CCRC preferred
- · Good Clinical Practice (GCP) preferred
- · 2 years of clinical research experience is required
Position Type/Expected Hours of Work:
- This is a full-time position. Days and hours of work are Monday through Friday, 7:00 a.m. to 4:00 p.m., hours may change/vary per business needs.
- Walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-borne pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.