Research Coordinator II (Contract position)

Job Title: Research Coordinator II (Contract position)

Location Detail: Ear, Nose, & Throat Surgeons of Western New England, Springfield, MA

Shift Detail: Part-time, hybrid

Compensation: $26-$31 per hour

The Association of Migraine Disorders (AMD) strives to expand the understanding of migraine by supporting research, education, and awareness. The research mission of AMD is devoted to accelerating neuroscience research that will advance the understanding of migraine disease, ultimately improving the lives of those living with the disease.

AMD is seeking a Research Coordinator II based in the Springfield, MA area to serve as the Clinical Research Coordinator for a study that AMD is sponsoring. The study is evaluating the feasibility of a novel endoscopy technique to treat headache and facial pain and/or pressure.

Responsibilities

In compliance with all regulatory, institutional, and departmental requirements, the Research Coordinator II will have the following responsibilities:

• Coordinate and conduct the operation of the study per Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines including participant recruitment; informed consent; continuous monitoring of the protocol for compliance and patient safety; source document review; preparation of study materials; data entry; sponsor monitoring.
• Interact/collaborate with physicians, other members of the health care team, and study participants/families in a manner that supports the conduct of clinical trials.
• Train study participants on how to use the study electronic headache diary.
• Attend research meetings and provide study updates.
• Document data into various electronic data capture systems and complete data entry within protocol timelines.
• Prepare study calendars and materials; maintain participant tracking logs and screening/enrollment logs.
• Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting, and continuing reviews.
• Assist the study sponsor with clinical trial billing in the resolution of related queries.
• Assist/coordinate preparation for internal and external audits.
• Assume additional responsibilities as required.

Qualifications

• Bachelor’s degree (in Nursing, Pharmacy, or Healthcare/Science-related field).
• Minimum of 2-3 years of clinical research experience.
• Certified Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred but not required.
• Demonstrates clinical competency with patient-related measurements and with a high degree of accuracy with respect to documentation and data collection.
• Ability to work with spreadsheets (such as Excel), familiarity with electronic data capture platforms (examples: Lumiio, Qualtrics, REDCap, Viedec, Medidata Rave, Oracle Clinical).
• Experience in preparing and completing Case Report Forms (CRF’s), eligibility checklists, and other relevant documentation protocols.
• Familiarization with the use of mobile applications
• Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated team.
• Ability to travel to the Springfield, MA office for in-person patient visits and to conduct patient follow-up phone calls.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees/consultants assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

AMD embraces diversity and equality, and is committed to building a team with a variety of backgrounds, skills, and views. The more inclusive we are, the better our work will be. Creating a culture of Equality isn't just the right thing to do; it's also the smart thing.

Pay: $26.00 - $31.00 per hour

Work Location: Hybrid remote in Springfield, MA