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Manager, Special Projects

2 months ago

DeLand, United States Alcanza Clinical Research Full time
Job DescriptionJob DescriptionDescriptionAlcanza 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.

Position Summary:  The Manager, Special Projects – Operations Team (SPOT) is responsible for the execution of assigned study support at various site locations, as well as oversight and support of clinical and systems trainings throughout the organization, as needed.  

Key ResponsibilitiesEssential 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.·         Collaborating with departments leaders in Study Deliver, Operations, Strategy, and Training to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), and delivery quality data to sponsors.·         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).

·         Collaborating with management to support site performance goals, proactively identify and resolve issues, meet expected study milestones (such as site activation targets, enrollment targets, etc.), and ensuring overall quality of the data.

·         Assisting with initial and ongoing trainings for new and existing staff, regarding clinical systems, protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), GCP, IATA, and clinical plans and guidelines.

·         Overseeing site staff assigned to the studies, and assigned to assist various sites, and routinely assessing work outcomes, performance, and compliance

·         Overseeing people management activities including interviewing and selection, performance appraisals, employee counseling, career coaching and performance meetings. Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations.·         Overseeing team timecards and pay, absence tracking/approvals, new hire orientation and training for assigned staff / teams per operational needs.·         Under the direction of the Site Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP/GDP/ALCOAC, ICH regulations and guidelines:

a.       Screening of patients for study enrollment

b.       Patient consents

c.       Patient follow-up visits

d.       Documenting in source clinic charts

e.       Entering data in EDC and answers queries         

                                                                                                                                         
f.        Obtaining vital signs and ECGs

g.       May perform basic lab procedures per protocol, such as:  blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up

h.       Requesting and tracking medical record requests

i.         Updating and maintaining logs, chart filings

j.         Maintaining & ordering study specific supplies

k.       Scheduling subjects for study visits and conducts appointment reminders

l.         Building/updating source as needed

m.     Conducting monitoring visits and resolves issues as needed in a timely manner

n.       Ensuring study related reports and patient results are reviewed by investigator in a timely manner

o.       Filing SAE/Deviation reports to Sponsor and IRB as neededp.       Documenting and reporting adverse eventsq.       Reporting non-compliance to appropriate staff in timely manner·         Complete all needed activities for individual and team’s study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.·         Ensuring individual and team adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures.·         Collaborating with investigators, site teams, and support teams, to meet goals and timelines.·         Employing problem-solving skills to propose and implement risk mitigations.·         Participating and, at times, presenting in management, production, and site meetings.·         Perform all other duties as required or assigned.

Skills, Knowledge and ExpertiseMinimum Qualifications:  A Bachelor’s degree and a minimum of 5 years of clinical research 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 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, 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.