Clinical Operations Manager
7 days ago
We are seeking a highly skilled and experienced Clinical Operations Manager to join our team at Page Mechanical Group Inc. As a key member of our clinical research team, you will be responsible for overseeing the day-to-day operations of our clinical research unit.
Key Responsibilities- Ensure that all clinical activities adhere to International Council on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and company Standard Operating Procedures (SOPs).
- Study and understand thoroughly all clinical research studies being performed in the unit through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Clinical Research Coordinators and the Principal Investigator.
- Lead the clinical team in understanding all clinical trials being performed in the unit, facilitating trainings, and providing related communication to ensure this.
- Ensure that all clinical activities adhere strictly to study protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and other requirements.
- Educate team members and support them in educating patients and their family members regarding the clinical trials process and the details of the specific study in which they're participating.
- Oversee patient enrollment, ensuring that the informed consent process is properly performed and documented.
- Facilitate the confirmation of eligibility of potential patients through chart review processes.
- Communicate clinical trial issues to Sponsor and/or Contract Research Organization (CRO), Principal Investigator, and Clinic Manager.
- Ensure that all required source documents are created, updated, and available for use in a timely manner, with a mind toward creating documents that reduce data entry errors and ensure compliant data collection meeting all study protocol requirements.
- Ensure that all clinical source documentation is up-to-date and in compliance with ALCOA-C standards.
- Communicate closely with the sponsor's in-house and travel Clinical Research Associates (CRAs) to facilitate the sponsor monitoring and data maintenance process.
- Calmly and professionally manage conversations with patients and caregivers who become upset or frustrated during the clinical research process.
- Ensure patient and caregiver safety by responding appropriately to any potentially harmful situations that arise during their study participation.
- Work diligently to maintain excellence in clinical trial performance, both in study enrollment and in clinical trial data collection. Review systems and study performance to continually identify areas of potential improvement.
- Identify potential problems or inconsistencies and take action as appropriate.
- Ensure excellent communication regarding clinical issues with the clinical team, sponsor, CRO, monitors, auditors, and/or vendor groups.
- Provide continuing training and oversight of clinic team members.
- Ensure all clinical team members, including Clinical Research Coordinators (CRCs) and Research Assistants (RAs) are in compliance with trainings and certifications to maintain required standards for performing study functions as required by sponsors and CROs.
- Ensure all clinical team members, including CRCs and RAs are appropriately delegated to perform study procedures, as appropriate.
- Facilitate scheduling for clinic visits and resolve related issues in a timely manner.
- Ensure the completion of all monitor and sponsor queries in a timely manner.
- Track the enrollment status of patients and ensure timely communication with patients regarding their study participation.
- Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
- Know the company's core values and ensure these values are continually practiced and developed by the team.
- Develop and maintain positive and effective working relationships with all Charter Research team members.
- Perform additional duties as assigned.
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; coaching and mentoring employees; addressing complaints and resolving problems.
Requirements- Must possess a strong work ethic and a high level of motivation to grow and improve the site's clinical operations.
- Ability to think broadly and maintain a working knowledge of all aspects of clinical trial operations.
- Ability to manage and lead a team.
- Excellent communication and interpersonal skills.
- Exceptional organizational and planning skills and attention to detail.
- Agility to handle multiple tasks simultaneously and adapt to changes in responsibilities and workloads.
- Knowledge of medical terminology.
- Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters, and other sensitive information.
- Language: Fluent in both English and Spanish.
- Education: Bachelor's degree strongly preferred – preferably in psychology, biology, health sciences, or a related field.
- Certified Clinical Research Coordinator (CCRC) certification preferred.
- Licensed Practical Nurse (LPN), Registered Nurse (RN), or other medical licensure or certification is a plus.
- Experience: 1-3 years of relevant clinical research experience required.
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