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Form of workJob Description
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.
Perform routine medical laboratory tests for the diagnosis, treatment and prevention of disease. Responsible for operation of the laboratory.
Responsibilities:
• Perform technical laboratory functions including chemistry, hematology, urinalysis and immunology.
• Report test results following clinic protocols alerting providers and/or nurses about abnormal results.
• Ensure quality control in collecting specimens, ensure appropriate sampling and maintain accurate record keeping.
• Maintain laboratory equipment and supplies. Set up, maintain, calibrate, clean, and test sterility of medical laboratory equipment.
• Comply with all laboratory policies and OSHA regulations related to safety, cleanliness and infection control.
• 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 Compass Research
• 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 particular 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
Qualifications:
1. HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
2. Prior experience in a clinical environment preferred. Experience in Clinical Research is ideal.
3. Bi-lingual in English and Spanish required
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 considered.
