Research Assistant

At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most.

K2 is seeking a Clinical Research Assistant to support our clinic out of The Villages, FL in our Phase I Healthy Studies Unit.

The Clinical Research Assistant will support clinical trial performance and conduct congruent to the philosophy and mission of K2 Medical Research. Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation.

Primary Responsibilities

• Track and move candidates through screening efficiently. Aiding the coordinators and keeping subjects from falling through the cracks.
• Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator.
• Assist the Site Director and Project Management team on projects as needed.
• Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate.
• Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator.
• Articulate all pertinent issues to the Pl or document by email/letter or during meetings.
• Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources.
• Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor{s), Auditors and any marketing groups hired by the Sponsor.
• Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Med.
• Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging.
• Maintain timely K2 Medical Research source documentation as well as sponsor required information.