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
...Residential Services, Inc. (RSI) is hiring part-time Direct Support Professionals (DSPs) for our adult foster care homes in Duluth, MN. As a DSP, you will help people with disabilities and mental illness live their best, most fulfilling lives. If you are compassionate, warm-...
...will start in July 2025; or at an earlier mutually agreeable time. This hiring is part of a multi-year strategic hiring plan, and entry-level, junior, and senior lateral candidates will be considered. Candidates should demonstrate evidence of or potential for outstanding...
...Door to Door Are you outgoing, motivated, and ready to kickstart your career in solar sales? As an Entry-Level Solar Sales Appointment Setter , you'll play a key role in helping homeowners transition to renewable energy. Your primary responsibility will be to knock...
...turnout for the upcoming election. Work independently or as part of a team to hit daily and weekly voter outreach goals. What We Offer: Competitive Pay: $25/hour, paid weekly. Flexible Hours: Choose shifts that fit your schedule, including weekends. Paid...
...Special Education Teacher (Private setting) Certified Special Education Teacher needed for a private clinic. Duties include: Developing and implementing educational goals for home school programs at our clinic, which also offers ABA and behavioral support....