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Clinical Trials Project Supervisor
2 months ago
Position Summary:
The Clinical Research Coordinator/Project Manager is responsible for overseeing the execution of clinical trials, ensuring alignment with the mission and values of K2 Staffing LLC. This role is pivotal in promoting adherence to ethical clinical practices by leveraging a comprehensive understanding of federal regulations and K2 Staffing LLC's operational protocols for participant enrollment and management throughout the study lifecycle.
Key Responsibilities:
• Acquire a thorough understanding of all assigned clinical studies by reviewing protocols, participating in investigator meetings, and collaborating with the Principal Investigator.
• Strictly follow the study protocol and seek necessary exemptions when appropriate.
• Communicate any protocol-related issues to the Contract Research Organization (CRO), Sponsor, Site Administrator, Director, Principal Investigator, or Sub-Investigator.
• Document all relevant discussions and issues with the Principal Investigator through written communication or during meetings.
• Gather initial psychiatric and medical histories by interviewing participants and accessing relevant sources.
• Facilitate effective communication among patients, study personnel, referral sources, Sponsors, CROs, monitors, auditors, and marketing teams engaged by the Sponsor.
• Employ various psychiatric assessment tools while maintaining consistency in evaluations with other clinicians at K2 Staffing LLC.
• Execute clinical tasks such as taking vital signs, measuring height and weight, performing ECGs, conducting phlebotomy, and packaging specimens.
• Ensure timely and accurate documentation in compliance with K2 Staffing LLC and Sponsor requirements.
• Manage and maintain precise records of study medications.
• Educate participants and their families about the study specifics and the broader context of clinical drug trials.
• Address all inquiries from monitors and Sponsors promptly.
• Provide suitable community resource referrals to participants and their families upon conclusion of their involvement in the study.
Essential Skills and Qualifications:
• Exceptional verbal and written communication abilities.
• Strong interpersonal skills and a commitment to customer service.
• Excellent time management and organizational capabilities.
• In-depth knowledge of industry regulations.
• Proven capacity to cultivate mentoring relationships.
• Ability to drive momentum and facilitate organizational change.
Education and Experience:
• High School Diploma or GED required; Bachelor's degree preferred.
• Previous experience in a clinical setting is preferred, with a strong background in clinical research being ideal.
• Licensure or certification as an LPN, RN, or similar is preferred.
• Comprehensive understanding of Good Clinical Practice (GCP) and FDA guidelines.
• Familiarity with medical terminology.
• BLS Healthcare Provider certification required.
• Bilingual candidates are preferred.
• Candidates who do not meet all qualifications but possess a combination of relevant education and experience may be considered upon approval.
