
Clinical Trial Manager
2 days ago
We are seeking a highly skilled professional to manage clinical trials and ensure studies follow federal regulations and company guidelines. The successful candidate will be responsible for handling all necessary documentation for subject enrollment and maintenance, including vital signs, height and weight, ECG, phlebotomy, specimen packaging, and study medication.
Key Responsibilities:- Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with the Principal Investigator
- Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate
- Communicate protocol issues to relevant parties, including CROs, sponsors, site administrators, directors, and principal or sub-investigators
- Collect initial psychiatric and medical information by interviewing patients and accessing other appropriate sources
- Ensure a flow of communication between patient, study staff, referral sources, sponsors, monitors, auditors, and any marketing groups hired by the sponsor
- Utilize various psychiatric rating scales and maintain interrater reliability with other clinicians at K2 Medical Research
- Perform clinical tasks, including but not limited to, phlebotomy, specimen packaging, and maintaining accurate records of study medication
- Maintain timely source documentation as well as sponsor-required information
- Educate patients and family regarding their particular study and clinical drug trials in general
- Outstanding verbal and written communication skills
- Excellent interpersonal and customer service skills
- Strong time management and organizational skills
- In-depth knowledge of industry regulations
- Proven ability to foster mentoring relationships
- Ability to create momentum and foster organizational change
- BLS Healthcare Provider certification required
- Knowledge of medical terminology
- Strong working knowledge of GCP and FDA guidelines
- HS Diploma or GED required; Bachelor's degree strongly preferred
- Two years of experience in a clinical environment; experience in clinical research is ideal
- Bilingual in Spanish and English strongly preferred
- Applicants with related education and applicable experience may be considered upon approval
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