Job Description
Description:
The Project Manager will manage clinical trial performance and ensures conduct is 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
• 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 Medical 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
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.
• Strong working knowledge of GCP and FDA guidelines
• Knowledge of medical terminology
• BLS Healthcare Provider required
• Bilingual Preferred
• Applicants that do not meet 100% of the above qualifications but who have a combination of related education and applicable experience may be considered upon approval
...Job Type: Full-Time. The Nurse Consultant/ Regional Director of Clinical Operations position is comprised of two essential objectives; to partner with facilities as the primary clinical resource in the pursuit of clinical excellence and, to assist in the development...
Truck Driver CDL A Home Daily Job at Ryder System, Sacramento, CA Job Description **Position Description**Immediately Hiring a Dedicated SOLO Class A CDL Driver in Sacramento, CA.We want the right Employee to Drive with us at Ryder.For more info Text Kaylee "Sacramento"...
...informed care is preferred Career Advancement Programs The Opportunity: This position manages residential program, including expressive therapy, behavioral health therapy, and education program. Provides direct supervision to residential and expressive therapy...
...textbooks for their longevity, excellence, and impact in the academic marketSan Diego, CA April 23, 2025 Three Cognella titles... ...com/family-interaction-9798823337717When the book was first published, we wanted to focus on helping readers understand how the form...
...Swedish-Speaking Customer Support Representatives Looking for a role where your love for the Swedish language and helping others plays a major factor? Our client is currently looking for Swedish-Speaking Customer Support Representatives to provide excellent customer...