VP, Clinical Research Site Operations - Based on East coast preferred - Alcanza Clinical Research
Lake Mary, FL 32746
About the Job
Description
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The VP, Site Operations is responsible for driving operational performance for a defined territory of research sites. Provides on-site leadership and management and to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures.
The VP, Site Operations is responsible for driving operational performance for a defined territory of research sites. Provides on-site leadership and management and to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures.
Key Responsibilities
Essential Job Duties:
- Overall team management and support with a focus on supporting various sites with a high performing team, to enhancing efficiencies, ensure patient safety and protocol/GCP/regulatory compliance, and meet targets.
- Collaborate with departments leaders, investigators, site and support teams, to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), delivery quality data to sponsors, and meet company financial targets.
- Review and utilize operational data, metrics and reports to identify opportunities in expanding operational output and risks to deliverables. Review the performance dashboards and other clinical trial systems to oversee site and patient activities, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) .
- Oversee resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identify risks to delivery or quality, and escalate any risks to clinical trial management deliverables (timeline, quality and budget).
- Collaborate with internal SG&A teams to ensure seamless coordination and execution of site operations activities and future commitments.
- Track and report on site operation activities: Maintain accurate records of sales activities, monitor progress against targets, and generate regular reports to senior management on site activities, pipeline, and performance metrics.
- Proactively identify and resolve issues, and work to ensure successful site operations.
- Oversee people management activities including interviewing and selection, performance appraisals, employee counseling, career coaching and performance meetings. Overseeing team timecards and pay, absence tracking/approvals, new hire orientation and training for team per operational needs.
- Ensure individual and team adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures.
- Represent the organization: Act as a brand ambassador for the organization at industry conferences and other relevant events, promoting our services and building awareness and credibility in the clinical research community.
- Participate, lead and/or present in management, production, BOD, and site meetings.
- Perform all other duties as required or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: A Bachelor’s degree in life sciences, business, or related field and a minimum of 8 years related experience, or an equivalent combination of education and experience, is required. 2 or more years of management experience in clinical research is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
- Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines.
- Well-developed written and verbal communication and presentation skills, with the ability to effectively convey complex concepts to diverse audiences.
- Well-developed interpersonal and listening skills and the ability to work well independently, collaboratively within a team environment, with clients and sponsors, and with all levels within the organization.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of professionalism, integrity, dependability, respect of others, self-motivation, and exemplify a strong work ethic.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, in compliance with HIPAA guidelines.
Benefits
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Source : Alcanza Clinical Research
