Research Assistant
K2 Medical Research · Maitland, FL · 1 wk ago
AnalystFull-time
About the role
K2 Medical Research is seeking a Clinical Research Assistant to support our clinic in Orlando (Maitland), FL. This role will support clinical trial performance and conduct in alignment with K2’s philosophy and mission, promoting good clinical practices through in-depth knowledge of federal regulations and K2’s guidelines (SOPs) for enrolling and maintaining subjects in clinical trials. You will collect, record, and maintain source and sponsor documentation.
Responsibilities
- Track and move candidates through screening efficiently, ensuring no subjects fall through the cracks.
- Thoroughly understand all assigned studies by reading protocols, attending investigator meetings and start-up meetings, and coordinating with the 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 Principal Investigator or document them via email/letter or during meetings.
- Collect initial psychiatric and medical information by interviewing patients and accessing other appropriate sources.
- Ensure a flow of communication, including telephone conferences, between patient, study staff, referral sources, Sponsor and/or CRO, Monitors, Auditors, and any marketing groups hired by the Sponsor.
- Utilize various psychiatric rating scales and maintain interrater reliability with other clinicians at K2 Med.
- Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, and specimen packaging.
- Maintain timely K2 Medical Research source documentation as well as sponsor-required information.
- Dispense and maintain accurate records of study medication.
- Educate patients and family regarding their study and clinical drug trials in general.
- Complete all monitor and sponsor queries in a timely manner.
- Provide appropriate community resource referrals to patients, caretakers, and family at the conclusion of a patient’s participation in a study.
Requirements
- HS Diploma or GED Transcript required; Bachelor’s degree strongly preferred.
- Prior experience in a clinical environment preferred; experience in clinical research is ideal.
- LPN, RN, or other medical licensure or certification preferred.
- Applicants who don’t meet 100% of the above qualifications but have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be considered.
Skills
- Outstanding verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Strong time management and organizational skills.
- In-depth knowledge of industry regulations.
- Proven ability to foster mentoring relationships.
- Ability to create momentum and foster organizational change.
Benefits
- Comprehensive benefits package for full-time employees, including medical, dental, and vision options.
- Supplemental insurance plans.
- 401(k) with immediate employer match.
- Generous paid time off and paid holidays.
Schedule
Four-day work week, consisting of 10-hour shifts from Monday through Thursday. Fridays are reserved only for critical business needs or administrative tasks; otherwise, they are your chance to start your weekend early.