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 Clinical Operations Manager will be responsible for the research site. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, and FDA guidelines and follows company policies and procedures.
Key Responsibilities
Essential Job Duties:
- Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety, and protocol/GCP/regulatory compliance;
- Collaborating with departments leaders in Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and deliver quality data to sponsors;
- Reviewing the performance dashboards and other clinical trial systems to oversee the site and patient activities, ensure proper staff coverage, and ensure the data has been updated to reflect the timely execution of all operational aspects (required visits/calls, duration, and frequency);
- Overseeing resourcing allocations, site assignments, and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality, and budget);
- Assisting with initial and ongoing training regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study;
- Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures;
- Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifying 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 assigned site staff, proactively identifying and resolve issues, and working to ensure successful site operations;
- Overseeing all payroll, absence tracking/approvals, new hire orientation, and training for assigned staff/teams per operational needs;
- Collaborating with investigators to ensure patient safety and meeting client goals and timelines;
- Employing strategic thinking and problem-solving skills to propose and implement risk mitigations;
- Participating and presenting in management or site meetings;
- Perform all other duties as required or assigned.
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. 3+ or more years of management experience is required. Bi-lingual (English / Spanish) proficiency is preferred.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, and 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.
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.
About Alcanza Clinical Research
Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
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