Alcanza Clinical Research

Compensation

Full Description

Clinical Research Regional Director of Operations (East Coast preferred) Department: Operations Employment Type: Full Time Location: Alcanza Corporate Reporting To: Hayley Molin 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 Director, Regional 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 territory site management and leadership with a focus on driving sites performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance. Overall site management at one or more sites, with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance. Collaborating with other functional leaders in Business Development, Patient Recruitment, Budgets and Contracts and Quality to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets, etc. Reviewing 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) . Using operational data, metrics and reports to identify opportunities in expanding operational output and risks to deliverables. Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, and identifying risks to delivery or quality. Escalating any risks to clinical trial management deliverables (timeline, quality and budget). Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study. Serving as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying managers at sites for observation or conflict resolution. Maintaining and reporting key performance metrics to support operational excellence and business development. Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures. Overseeing site staff and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Overseeing people management activities including interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and termination meetings. Managing site staff, proactively identify and resolve issues, and work to ensure successful site operations. Overseeing payroll timecards, absence tracking/approvals, new hire orientation and training per operational needs. Interacting with sites and enterprise leadership to ensure the strong performance of the region. Collaborating with investigators to ensure patient safety and meeting client goals and timelines. Identifying project issues and alerting senior department management with a view to recommendations. Employing strategic thinking and problem-solving skills to propose and implement risk mitigations. Participating and presenting in management or site meetings Performing other related duties as assigned. May be required to travel within region up to 50% of the time, and nationally up to 10%, dependent on business needs. Skills, Knowledge and Expertise Minimum Qualifications: A Bachelor’s degree and a minimum of 8 years of clinical research experience, or an equivalent combination of education and experience, is required. 5+ or more years of management experience is required. 2+ years of multi-site research management experience is highly preferred. An active driver’s license, in good standing, current car registration & auto insurance is required. 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 skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. 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 integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. May be required to travel within region up to 50% of the time, and nationally up to 10%, dependent on business needs. 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.