What are the responsibilities and job description for the Clinical Research Coordinator / Project Manager position at K2 STAFFING LLC?
Job Description
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 :
Qualifications :
