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
...everyone succeeds when they are empowered to be creative, thoughtful and compassionate. Every day, we set the standard for rare and special luxury service the world over and pride ourselves on delivering excellence in the care and comfort of our guests. Your role will be...
...An eDiscovery Project Manager (PM) is the Government's primary point of contact for all support on eDiscovery and staffing projects. The PM is primarily responsible for all support provided to a particular case, particularly coordinating the collection, tracking, processing...
...versatile event space! This is a great opportunity to join the Aimbridge Family, the global leader in third-party hotel management, and... ....+ Maintain regular attendance in compliance with Aimbridge Hospitality standards as required by scheduling which will vary according...
...Excellent Opportunity to join this established Plastic Surgery Center with expansion to Dealray Beach, West Palm Beach and Wellington, Florida Do bread and butter procedures including: Tunny Tucks, Liposuction, Breast Augmentation. Practice offers Aesthetics as...
...Job Description Advocate Aurora Health is seeking a Registered Nurse (RN) Manager, Oncology for a nursing job in Wauwatosa, Wisconsin. Job Description & Requirements ~ Specialty: Oncology ~ Discipline: RN ~ Duration: Ongoing ~40 hours per week ~ Shift...