Alcanza Clinical Research

Clinical Research

• 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.

Clinical Research Regional Director – Operations

• **Essential Job Duties:******
• - Ability to phone screen patients or caregivers in caring and empathetic manner.
• - Document patient information correctly in the computer database
• - Schedule/reschedule patient screen and prescreen appointments.
• - Manage incoming calls from patients interested in taking part in research studies.
• - Evaluate eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with site clinic staff.
• - Learn and maintain knowledge regarding clinical research studies including inclusion and exclusion criteria for different studies.
• - Record contact status of patients and document information in the database.
• - Review, call and update sponsor patient portals as needed.
• - Perform all other duties that may be requested or assigned.

Clinical Research Patient Recruiter

Recruitment

• Facilitate the hiring of qualified job applicants for open positions from the point of writing/modifying job descriptions, collaborating with managers on requirements and skills needed, sourcing, posting, interviewing, extending offers, negotiating details, producing offer letters and employment agreements, and onboarding.
• Processes all internal and external applications, resumes, and transfer requests.
• Ensure compliance with applicable provisions of federal and state labor laws. Ensures all records, logs and files are maintained to meet regulatory requirements and corporate policies.
• Assists with training managers, supervisors and employees on HR policies, program changes and procedures.
• Ensures HR and Company policies are followed, especially with regard to the recruitment process, and pay/compensation guidelines.
• Monitors and reports on employee headcount, Turnover Reports, Time to Fill, and Requisition Reports, compiles data, prepares and distributes reports as requested.
• May assist with planning and coordinating new employee orientation to foster a welcoming, positive culture and team atmosphere.
• Stays up to date with best practices, laws and emerging trends.
• Perform all other duties that may be requested or assigned.

Talent Acquisition Specialist

• Work to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs
• Collaborate with other members of the clinical research site team
• Screening of patients for study enrollment
• Patient consents
• Patient follow-up visits
• Documenting in source clinic charts
• Entering data in EDC and answers 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 conducts appointment reminders
• Building/updating source as needed
• Conducting monitoring visits and resolves 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
• Practicing ALCOAC principles with all documentation
• Assisting with study recruitment, patient enrollment, and tracking as needed
• Maintaining confidentiality of patients, customers and company information
• Performing all other duties as requested or assigned
• Complete all needed activities for study start-up, including completing required training
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
• May set up, train and maintain all technology needed for studies

Traveling Clinical Research Coordinator – Vaccine Trial Experience Required

• Support revenue recognition systems and processes, identifying automation opportunities and helping to ensure data accuracy and consistency across systems.
• Partner with operations and budgets/contracts colleagues to implement best practices in a scalable manner and establish revenue-based performance metrics.
• Issue invoices and pursue timely collections of AR from sponsors/CROs to reduce Days Sales Outstanding; communicate with customers regarding balances, questions, and discrepancies.
• Perform timely study closeout reconciliations across both the CTMS and financial ERP systems.
• Support month-end close, bank and management reporting, and the annual financial audit while maintaining established timelines.
• Complete timely and accurate cash application at the item level for all payments received.
• Complete various aspects of G/L accounting including preparation/processing journal entries and reconciling accounts following GAAP.
• Actively participate in special projects, including process standardization, system migrations, and integration of newly acquired sites’ processes and systems.
• Identify opportunities to improve business processes and efficiencies.
• Perform all other duties that may be requested or assigned.

Senior Revenue and Project Specialist – Clinical Research

• Screening of patients for study enrollment;
• Patient consents;
• Patient follow-up visits;
• Documenting in source clinic charts;
• Entering data in EDC and answers 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 conducts appointment reminders;
• Building/updating source as needed;
• Conducting monitoring visits and resolves 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;
• Always practicing ALCOAC principles with all documentation;
• May assist with study recruitment, patient enrollment, and tracking as needed;
• Maintaining confidentiality of patients, customers and company information, and;
• Performing all other duties as requested or assigned.
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• May set up, train and maintain all technology needed for studies.

Clinical Research Coordinator

Digital Marketing

• Develop, implement, and optimize comprehensive paid media strategies across Google Ads, Meta, LinkedIn, TikTok, Twitter, and programmatic channels.
• Oversee end-to-end execution of digital advertising campaigns: budgets, audience targeting, creative testing, bidding strategies, and ongoing performance optimization.
• Monitor, analyze, and report on campaign performance using analytics tools; translate data into actionable insights and regular reports for stakeholders.
• Lead and mentor a team of performance marketing specialists; collaborate with creative, content, product, and data teams; may manage hiring, training, timecards, and employee counseling.
• Manage substantial media budgets across multiple channels and identify opportunities to scale successful campaigns.
• Stay ahead of digital marketing trends, test new ad formats and targeting tactics, and champion a culture of experimentation.
• Serve as main point of contact for paid media initiatives; communicate progress and recommendations to senior management and cross-departmental teams.
• Ensure campaigns adhere to legal, industry, and brand guidelines; manage risk related to ad placement, privacy, and platform policies.
• Participate in and lead meetings; liaise with clients and stakeholders; maintain a positive, results-oriented work environment.
• Perform other duties as requested or assigned.

Lead Digital Marketing and Paid Media Specialist – Clinical Research

• Ability to phone screen patients or caregivers in caring and empathetic manner.
• Document patient information correctly in the computer database
• Schedule/reschedule patient screen and prescreen appointments.
• Manage incoming calls from patients interested in taking part in research studies.
• Evaluate eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with site clinic staff.
• Learn and maintain knowledge regarding clinical research studies including inclusion and exclusion criteria for different studies.
• Record contact status of patients and document information in the database.
• Review, call and update sponsor patient portals as needed.
• Perform all other duties that may be requested or assigned.

Patient Recruiter, 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

• 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

• 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.

• 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

• 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 Regional Director – Operations

Clinical Research Patient Recruiter

Talent Acquisition Specialist

Traveling Clinical Research Coordinator – Vaccine Trial Experience Required

Senior Revenue and Project Specialist – Clinical Research

Clinical Research Coordinator

Lead Digital Marketing and Paid Media Specialist – Clinical Research

Patient Recruiter, Clinical Research

Clinical Research Coordinator, Vaccine Trials

Clinical Research Physician – Internal Medicine

Clinical Research Coordinator

Patient Liaison, Patient Recruitment

Director, Information Technology - Clinical Research