Job Description
Job Description
K2 is seeking a Clinical Research Assistant (1099) to support our clinic out of The Villages, FL. 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:
- 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.
- 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 conclusion of patient's participation in study.
Knowledge, Skills, and Abilities:
- Outstanding verbal and written communication skills.
- Excellent interpersonal and customer services skills.
- Strong time management and organizational skills In depth knowledge of industry regulations.
- Proven ability to and foster mentoring relationships.
- Ability to create momentum and foster organizational change.
Qualifications:
- 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 that don't meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be consider.
Join the K2 Family: Where Compassion and Connection Lead the Way!
At K2 Med, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.
We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at HR@k2med.com, and we'll ensure you have everything you need to shine.