Alcanza Clinical Research

Clinical Research

• Screen patients for study enrollment.
• Obtain patient consents and conduct patient follow-up visits.
• Document in source clinic charts and build/update source documentation as needed.
• Enter data in EDC and answer queries.
• Obtain vital signs and ECGs; perform basic clinical procedures (blood pressure, vitals, EKGs, phlebotomy).
• Perform basic lab procedures per protocol: blood specimen collection, centrifuge operation, storing and shipping specimens, specimen accountability, and courier coordination.
• Request and track medical records; update and maintain logs and chart filings.
• Maintain and order study-specific supplies; schedule subjects for study visits and conduct appointment reminders.
• Conduct monitoring visits and resolve issues in a timely manner; ensure study reports and patient results are reviewed by investigator.
• File SAE/Deviation reports to Sponsor and IRB as needed; document and report adverse events; report non-compliance to appropriate staff.
• Maintain positive and effective communication with clients and team members; maintain confidentiality of patients, customers and company information.
• Complete study start-up activities including required training, uploading/printing certificates to ISF; prepare and attend site initiation visits (SIVs) and Investigator Meetings (IMs).
• May assist with study recruitment, enrollment, tracking, and set up/train/maintain study technology.
• Perform all other duties as requested or assigned.

Clinical Research Coordinator, Vaccine Trials

Recruitment

• Execute onsite patient pre-screening and pivot qualified patients into active studies for dedicated and local sites when patients are willing to travel.
• Evaluate eligibility of potential subjects through screening interviews, reviews of medical records, or discussions with site clinic staff.
• Support patient path to enrollment, managing all follow up and communication including reminder calls and rescheduling.
• Monitor/manage onsite patient screening visit schedule; schedule/reschedule appointments as needed or requested.
• Own No-Show/DNQ tracking, triaging, optimization.
• Capture/manage inbound physician referral leads.
• Address and resolve patient barriers to study entry by leveraging knowledge of site or sponsor-provided support services, such as transportation assistance and reimbursement programs.
• Ensure timely and consistent updating to Clinical Conductor/CTMS – updating patient touches/patient profile statuses.
• Create targeted call lists based on i/e criteria in CTMS to best target patient populations for call efficiency.
• Share accountability for regional recruitment results and drive screening numbers to meet recruitment goals set by leadership.
• Assist with collection of performance metrics related to attribution capability for screening visits.
• Immediately notify RSLs and/or recruitment leadership of any barriers and/or challenges to screens scheduled or completed.
• Acquire and continuously update knowledge of clinical research studies, including detailed understanding of inclusion and exclusion criteria.
• Manage patient portal leads (central campaigns) to include review, calling and updating patient leads.
• Monitor status of Refer-A-Friend campaigns.
• Represent company with HCP referral partners for local support and relationship management.
• Support planning and participate in local community outreach events to engage/educate patients about clinical trials, as needed.
• May assist with new recruiter training and retraining of current team members.
• Perform all other duties that may be requested or assigned.

Patient Liaison, Patient Recruitment

• In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
• Screening of patients for study enrollment.
• Patient consents and patient follow-up visits.
• Documenting in source clinic charts and building/updating source as needed.
• Entering data in EDC and answering queries.
• Obtaining vital signs and ECGs.
• 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.
• Requesting and tracking medical record requests; updating and maintaining logs, chart filings; maintaining & ordering study specific supplies.
• Scheduling subjects for study visits and conducting appointment reminders.
• Conducting monitoring visits and resolving issues as needed in a timely manner; ensuring study related reports and patient results are reviewed by investigator in a timely manner.
• Filing SAE/Deviation reports to Sponsor and IRB as needed; documenting and reporting adverse events; reporting non-compliance to appropriate staff in timely manner.
• Maintaining positive and effective communication with clients and team members; maintaining confidentiality of patients, customers and company information.
• Complete all needed activities for study start-up, including completing required training, uploading/printing certificates to file in ISF; prepare and attend site initiation visits (SIVs) and Investigator Meetings (IMs) as needed.
• May assist with study recruitment, patient enrollment, and tracking as needed; may set up, train and maintain all technology needed for studies.
• Perform all other duties as requested or assigned.

Clinical Research Coordinator

• 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 Principal Investigator conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes. Working with a local and central team drives clinical oversight and the quality of the assigned studies at the site.
• Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes
• Overall site leadership with a focus on enhancing efficiencies, patient safety and protocol/GCP /regulatory compliance
• Evaluates and assesses participants to ensure only eligible participants enroll into the trials.
• Participates and engages in successful delivery and retention of study participants.
• Interacts positively and collaboratively with sponsors, clients and team members.
• Practices attention to detail in recording data and participant information, following protocol guidelines and GCPs.
• Actively involved in protocol training for staff.
• Participate in Investigator Meetings (IMs), and continuing education activities in order to maintain current knowledge of recruitment affairs and issues.
• Perform other duties as assigned, requested, or required based on the needs of the participants, protocols and/or company.

Clinical Research Physician – Internal Medicine

• Serves as an advisor to the leadership team on complex matters such as, technology strategy, technology innovation, risk management and, security and compliance and is expected to stay current on the latest technology trends and innovation in clinical research
• Supports the development a technology and innovation strategy and leads the implementation of key initiatives aimed at enabling excellence in patient recruitment and engagement, study startup and delivery, and all shared services across a multi-site operation
• Leads implementation projects of complex enterprise systems (CTMS and eSource, eRegulatory, GL, CRM & marketing automation, HRIS, and other) leveraging a wide partner network of subject matter expertise to bring efficiency and scale
• Supports acquisition activities and leads consolidation and system integration projects to realize expected synergies and build a platform for scale
• Attracts, develops, mentors, and supports a team of technology professionals and fosters a culture of high-performance and cross-functional collaboration
• Develop an annual operating budget in support of overall company objectives and oversees all aspects of IT operations to ensure performance and service excellence
• Lead the development and implementation of IT policies & procedures to ensure confidentiality, security, high-availability, and integrity of data on company networks and systems
• Lead the development of an Information Security program and collaborate with 3rd party auditing firms to ensure compliance with regulatory guidelines (HIPAA, CCPA, other) and mitigating security and privacy risks
• Establish a network of IT vendors and use a hybrid partner model for developing a cloud-based infrastructure, telecommunications systems, and building out a service desk team to ensure a stable and reliable IT operation and high-availability of the network.
• Assumes overall ownership of all IT issues, ensuring production issues are on a fast path to resolution. (These work efforts may extend beyond the course of the agreed upon work schedule.)
• Assume people management responsibilities including interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching, and other employee meetings for assigned team. Manage department staff, proactively. identify and resolve issues, and work to ensure successful department operations and culture
• Oversee resourcing allocations, assignments and team members' output and performance to ensure deliverables are on track, identifying/addressing/escalating risks to deliverables or timelines.
• Perform all other duties that may be requested or assigned.

Clinical Research Coordinator, Vaccine Trials

Patient Liaison, Patient Recruitment

Clinical Research Coordinator

Clinical Research Physician – Internal Medicine

Director, Information Technology - Clinical Research