Clinical Research Coordinator/Project Manager

Project Manager
Description
Project Manager I 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

• Dispense and maintain accurate records of study medication
• Articulate all pertinent issues to the Pl or document by email/letter or during meetings
• Educate patients and family regarding their particular study and clinical drug trials in general.
• Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
• Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Medical Research
• Maintain timely K2 Medical Research source documentation as well as sponsor required information.
• Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
• Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
• Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study
• 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
• Complete all monitor and sponsor queries in a timely manner
• 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

Knowledge, Skills, And Abilities

• Strong time management and organizational skills In depth knowledge of industry regulations
• Ability to create momentum and foster organizational change
• Outstanding verbal and written communication skills
• Excellent interpersonal and customer services skills
• Proven ability to and foster mentoring relationships

Qualifications

• HS Diploma or GED Transcript required. Bachelor's degree strongly 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
• BLS Healthcare Provider required
• LPN, RN, or other medical licensure or certification preferred.
• Prior experience in a clinical environment preferred. Experience in clinical research is ideal.
• Strong working knowledge of GCP and FDA guidelines
• Knowledge of medical terminology
• Bilingual Preferred