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
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Research Services
Referrals increase your chances of interviewing at K2 Medical Research by 2x