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 Title: Guest Services Concierge****Summary:** As a Guest Services Concierge, you will have the exciting opportunity to provide an exceptional experience for our guests from the moment they reach out. Our concierge team is available Monday through Sunday, responding...
...Job Description Job Description Description: Tanner Clinic has an immediate opening for a Materials Specialist Location: Antelope A Hours: FT Essential Job Responsibilities: Prepare and process requisitions and purchase orders when needed for materials...
...0 employees, SGS operates a network of over 2,600 offices and laboratories around the world. Job Description The Scientist, Biologics (Biophysical Characterization) will act as a subject matter expert in higher-order-structure (HOS) and biophysical characterization...
...needs Complete Custom Point open enrollment kit orders Order bulk supplies, marketing materials and promotional items Complete Cigna Tree of Life orders and track/maintain inventory as necessary. Process & track sponsorships requests from end to end Use Excel...
...Onsite Join a prestigious landscape architecture firm in New York, NY dedicated to designing high-end residential landscapes and creating exceptional outdoor environments. As a Landscape Architect, you ll oversee projects from inception to completion, manage key milestones...