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 description :1. Very strong IP networking skills2. CCNA education courses or certification3. Knowledge and experience troubleshooting the first 4 layers of the OSI model.a. physical, data link, network, transport4. Has worked with and troubleshooted broadband...
...Changing the World, One Kibble at a Time Champion Petfoods is expanding! We are excited to announce we are looking for a Director, U.S. Petco Sales to join our rapidly growing company. Champion Petfoods is an award-winning pet food crafter with a reputation of trust...
...Spectra Tech has an immediate need for a Contract Manager in our corporate office in Oak Ridge, TN. The successful candidate must be able to perform complex assignments which require initiative and independent judgment in the selection and use of established principles...
...Postdoctoral Fellow - Henry Jackson Foundation for the Advancement of Military Medicine HJF is seeking a Postdoctoral Fellow responsible... ...vehicle (DMV) check if applicable. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities #J-18808-Ljbffr
.... Basic Life Support (BLS) certification from the American Heart Association (AHA). Job Summary and QualificationsSeeking a Clinical Medical Assistant, EMT or ATC for our practice who provides clinical expertise to ensure all patients receive high quality, efficient...