6 Clinical Development Director jobs in Lake Helen

Overview

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Summary:

The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocity's SOPs.

Responsibilities

Duties/Responsibilities:

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.
• Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
• Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person pre screens.
• Create and execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand product development life cycle and significance of protocol design including critical data points
• Understand the disease process or condition under study
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone's work on an ongoing basis and in preparation for monitor visits.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope
• Other duties as assigned

Qualifications

Education/Experience:

• Bachelor's degree and 2 years relevant experience in the life science industry OR
• Associate's degree with 4 years relevant experience in the life science industry OR
• High School Graduate and/or technical degree with minimum of 6 years relevant experience in the
  life science industry AND1 year Clinical Research Coordinator experience

Required Skills:

• Demonstrated knowledge of medical terminology
• Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Proficient ability to work in a fast-paced environment
• Proficient verbal, written, and organizational skills
• Proficient interpersonal and communication skills
• Proficient ability to work as a team player
• Proficient ability to read, write, and speak English
• Proficient ability to multi-task
• Proficient ability to follow written guidelines
• Proficient ability to work independently, plan and prioritize with minimal guidance
• Proficient ability to be flexible/adapt as daily schedule may change rapidly
• Must be detail oriented
• Demonstrated problem solving and strategic decision making ability.
• Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
• Demonstrated leadership ability

Required Physical Abilities:

• Sit or stand for long periods of time
  Travel locally and nationally
• Communicate in person and by a telephone
• Limited walking required
  Limited to lifting up to 30 pounds

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

Job Title: Clinical Research Nurse - Oncology
Job Description
The Clinical Research Coordinator II RN is responsible for planning, coordinating, evaluating, and performing nursing care for participants in assigned research projects. This role involves adhering to study protocols, FDA regulations, and ICH/GCP guidelines while advocating for patient safety and rights.
Responsibilities
+ Deliver safe care and demonstrate regard for the dignity and respect of all participants.
+ Maintain clinical competencies including physical assessment, phlebotomy, and IV insertion.
+ Practice Universal Precautions and abide by HIPAA regulations.
+ Maintain a clean and prepared clinical space, performing set-up and turnover procedures.
+ Participate in training programs to maintain licensure.
+ Utilize positive interpersonal communication skills with healthcare team members, patients, investigators, and sponsors.
+ Review informed consent documents with study candidates to ensure patient rights and safety.
+ Manage multiple clinical trial protocols, coordinating execution and follow-up, and performing accurate documentation.
+ Promote Principal Investigator oversight by advising on deviations and patient status.
+ Coordinate the work of support staff, laboratory technicians, and assistants to ensure adherence to research protocols.
Qualifications
+ Ability to perform clinical tasks and assist with minor procedures.
+ Ability to integrate into various clinical settings as needed.
+ Skills in physical assessment, phlebotomy, and IV insertion.
+ Associate degree in Nursing.
+ Minimum 2 years of Clinical Research experience.
+ 3+ years oncology experience
+ Current, active State of FL license as a Registered Nurse.
+ Basic Life Support (BLS) certification.
Work Environment
The position is based in a hospital setting, requiring interaction with various clinical teams and adherence to hospital protocols.
Pay and Benefits
The pay range for this position is $75000.00 - $98000.00/yr.
Benefits from Day One
Paid Days Off from Day One
Career Development
Whole Person Wellbeing Resources
Mental Health Resources and Support
Pet Insurance*
Workplace Type
This is a fully onsite position in Altamonte Springs,FL.
Application Deadline
This position is anticipated to close on Jul 31, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.

Director of Applications & Data - Clinical Research

Department: Information Technology

Employment Type: Full Time

Location: Alcanza Corporate

Reporting To: Karim Chalhoub

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, Applications & Data oversees all technology functions within Alcanza Clinical Research: participating in the development of a technology and applications strategy, leading vendor-supported system integrations stemming from M&A activities, and executing on innovative software and data projects to bring differentiated value to Alcanza. The Director will engage business leaders to align technology department execution with business objectives, manage vendors and 3rd parties to ensure a stable and reliable IT network and operation, and coordinate IT governance, security, and compliance activities to ensure business continuity and adherence to regulatory guidelines.

Key Responsibilities

Essential Job Duties:

• Collaborates with executive team on 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 shared services across a multi-site operation.
• Advises the leadership team on technical matters and is expected to stay current on the latest technology trends and innovation in clinical research (software, data, & AI/ML/LLM).
• Leads implementation projects of complex enterprise systems (CTMS, 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 integration of technology platforms to realize expected synergies and build scale.
• Attracts, develops, mentors, and supports a team of technology professionals and fosters a culture of high-performance and cross-functional collaboration.
• Executes a vendor partner model for further developing a cloud-based infrastructure, telecommunications systems and service/help desk teams 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.
• Collaborates with partners and subject matter experts to ensure compliance with HIPAA, privacy and security laws and other regulatory guidelines.
• Communicate and liaise with clients and all stakeholders (internal & external) in a timely and professional manner.
• Employ strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Perform all other duties that may be requested or assigned.

Skills, Knowledge and Expertise

Minimum Qualifications : A bachelor's degree in information technology or related field and a 10+ years' experience in an IT leadership role with management responsibility of internal staff and vendors, or an equivalent combination of education and experience, is required. Must have experience with health information systems (EHRs, EMRs, or Practice Management) and/or clinical research systems (CTMS, Source, Regulatory). Must have demonstrated experience in leading teams and executing against goals with an executive mindset (e.g., building a disciplined environment, strong performance output, etc.). Must have understanding of HIPAA Privacy and Security rule, and regulatory guidelines in healthcare and/or clinical research settings. Bi-lingual (English / Spanish) proficiency is a plus.

Required Skills:

• Proficiency with computer applications such as Microsoft applications (Word, Excel, PowerPoint, Outlook), internet, and the ability to type proficiently (40+ wpm)
• Proficiency with data and software development life cycle management and understanding of modern data and technology solutions such as Microsoft Fabric, Snowflake, and/or equivalent solutions on AWS or Google Cloud Platform.
• Strong organizational, time management, problem solving, and project management skills to meet firm deadlines.
• Well-developed written and verbal communication and presentation skills
• Well-developed interpersonal and listening skills and the ability to work well independently and collaboratively within a team environment, building trusted relationships with clients and sponsors, and with all levels within the organization.
• Well-developed strategic and analytical capabilities
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities
• Must possess a high degree of professionalism, integrity, dependability, respect of others, self-motivation, and exemplify a strong work ethic.
• Ability to work under minimal supervision, think independently, 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.

**All the benefits and perks you need for you and your family:**
- Benefits from Day One
- Paid Days Off from Day One
- Student Loan Repayment Program
- Career Development
- Whole Person Wellbeing Resources
- Mental Health Resources and Support
**Our promise to you:**
Joining AdventHealth is about being part of something bigger. Its about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better.
**Schedule:** Full Time
**The role youll contribute:**
The Senior Epic Beacon Research Clinical Analyst has a comprehensive understanding of system build and implementation, the ability to analyze and understand business problems, and the knowledge to make solution recommendations that meet the organizational goals of maintaining clinical and business systems. They provide a secure, effective, integrated patient care delivery system that continually improves outcomes, reduces cost, increases efficiency, and enhances patients' experiences. Primary responsibilities include collaborating with clinicians and end users of the system to design, build, test, train, implement, evaluate, and maintain Epic and other associated systems.
The Senior Epic Beacon Research Clinical Analyst must utilize the knowledge of clinical practice, computer science, and information technology to manage data and determine components that are suitable to build while maintaining alignment with the professional standards of practice. They are responsible for coordinating with physicians and end users in the analysis and documentation of workflows, performing gap analysis, identifying needed process changes, and developing future workflows during the implementation of new solutions or functionality. The ability to communicate with all levels of hospital leadership, clinicians, physicians, and ancillary department staff is essential for this position.
**The value youll bring to the team:**
+ Demonstrates advanced functional knowledge of Epic, applicable third-party solutions, and the Microsoft suite of products
+ Serves as a lead member of the Clinical Applications Team, dedicated to the development of electronic documentation solutions that support clinical workflow and practice and align with the current best practice standards.
+ Develops and maintain collaborative relationships with all stakeholders; meets with customers and sponsors to capture business & technical requirements
+ Demonstrates knowledge of processes within the facility department; assesses workflow processes, identifies gaps, defines necessary process changes, and develops future workflows related to the implementation of new solutions or functionality
+ Designs, builds and configures within assigned Epic system modules and any supporting third- party applications; develops and maintains system process documentation and outlines process steps using appropriate tools; identifies and implements requested changes to the system
+ Designs and develops test scripts and materials for end-to-end workflow testing; Performs unit, system, and integration testing per standards, to include negative and regression testing; documents outcomes.
+ Remains current on industry trends and vendor/application/system updates. Ensures that all software modifications/upgrades are working according to Epic specifications.
+ Follows departmental standards for software configuration control, quality assurance and version releases; Provides documentation on system upgrades and new releases of Epic applications; provides training if required
+ Troubleshoots issues or system deficiencies and initiates escalation procedures as required. Provides recommendations for resolution of the problems found
+ Demonstrates advanced knowledge of processes within the facility department.
+ Participates in or leads multiple cross-functional projects; Understands project planning and coordination methodologies using project management skills, tools, and lean methodologies. Communicates project status of deliverables, shared issues, end-user concerns, budget, and upcoming milestones.
+ Able to breakdown raw information and undefined problems into specific, workable components that in-turn clearly identify the issues at hand. Makes logical conclusions, anticipates obstacles, and considers different approaches to the decision-making process.
+ Provides guidance and acts as a resource for other analysts, project managers, and consultants
+ Actively participates in project, team, departmental and other meetings as required. Reports status updates, accomplishments, task and any barriers to manager.
+ Identifies and acts upon opportunities for continuous improvement.
+ Encourages prudent risk-taking, exploration of alternative approaches, and organizational learning.
+ Demonstrates personal commitment to change through actions and words. Mobilizes others to support change through times of stress and uncertainty.
+ Participates in the on-call responsibilities in support of a 24hrs/7days-production systems environment; acts as the primary support contact for the application's end-users
Qualifications
**The expertise and experiences youll need to succeed** **:**
**KNOWLEDGE AND SKILLS REQUIRED:**
+ Advanced of Microsoft suite of products
+ Extensive experience communicating complex technical concepts to a non-technical audience
+ Demonstrated creative problem-solving approach and strong analytical skills
+ Must have strong written and verbal communication skills
+ Knowledge of clinical/technical workflow
+ Work with minimal guidance
+ Rapid learner
**KNOWLEDGE AND SKILLS PREFERRED:**
+ 5 years of clinical or technical background
+ EMR application/implementation experience
**EDUCATION AND EXPERIENCE REQUIRED:**
+ College Degree (A.S, Diploma, B.A., B.S. or commensurate experience) in a field of study such as business, IS, or a healthcare related
+ Yearly participation in ongoing education either formal or through conferences, active professional organization participation, or journal presentations Required
+ Experience in Epic Beacon build, with a focus on oncology protocols and research workflow support.
**EDUCATION AND EXPERIENCE PREFERRED:**
+ College Degree (AS, Diploma, B.A., B.S.)
**LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:**
Epic Certification or ability to complete within 3 months of completing classes
Maintenance of current licensure or certification related to area of specialty (OT, PT, SLP, RN, RPH, RT, ARRT, etc.)
**LICENSURE, CERTIFICATION OR REGISTRATION Preferred:**
+ Epic Beacon Certification (current or past).
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.
**Category:** Information Systems
**Organization:** AdventHealth Information Technology
**Schedule:** Full-time
**Shift:** 1 - Day
**Req ID:** 25026479
We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.

**The role youll contribute:**
The Senior Epic Beacon Research Clinical Analyst has a comprehensive understanding of system build and implementation, the ability to analyze and understand business problems, and the knowledge to make solution recommendations that meet the organizational goals of maintaining clinical and business systems. They provide a secure, effective, integrated patient care delivery system that continually improves outcomes, reduces cost, increases efficiency, and enhances patients' experiences. Primary responsibilities include collaborating with clinicians and end users of the system to design, build, test, train, implement, evaluate, and maintain Epic and other associated systems.
The Senior Epic Beacon Research Clinical Analyst must utilize the knowledge of clinical practice, computer science, and information technology to manage data and determine components that are suitable to build while maintaining alignment with the professional standards of practice. They are responsible for coordinating with physicians and end users in the analysis and documentation of workflows, performing gap analysis, identifying needed process changes, and developing future workflows during the implementation of new solutions or functionality. The ability to communicate with all levels of hospital leadership, clinicians, physicians, and ancillary department staff is essential for this position.
**The value youll bring to the team:**
+ Demonstrates advanced functional knowledge of Epic, applicable third-party solutions, and the Microsoft suite of products
+ Serves as a lead member of the Clinical Applications Team, dedicated to the development of electronic documentation solutions that support clinical workflow and practice and align with the current best practice standards.
+ Develops and maintain collaborative relationships with all stakeholders; meets with customers and sponsors to capture business & technical requirements
+ Demonstrates knowledge of processes within the facility department; assesses workflow processes, identifies gaps, defines necessary process changes, and develops future workflows related to the implementation of new solutions or functionality
+ Designs, builds and configures within assigned Epic system modules and any supporting third- party applications; develops and maintains system process documentation and outlines process steps using appropriate tools; identifies and implements requested changes to the system
+ Designs and develops test scripts and materials for end-to-end workflow testing; Performs unit, system, and integration testing per standards, to include negative and regression testing; documents outcomes.
+ Remains current on industry trends and vendor/application/system updates. Ensures that all software modifications/upgrades are working according to Epic specifications.
+ Follows departmental standards for software configuration control, quality assurance and version releases; Provides documentation on system upgrades and new releases of Epic applications; provides training if required
+ Troubleshoots issues or system deficiencies and initiates escalation procedures as required. Provides recommendations for resolution of the problems found
+ Demonstrates advanced knowledge of processes within the facility department.
+ Participates in or leads multiple cross-functional projects; Understands project planning and coordination methodologies using project management skills, tools, and lean methodologies. Communicates project status of deliverables, shared issues, end-user concerns, budget, and upcoming milestones.
+ Able to breakdown raw information and undefined problems into specific, workable components that in-turn clearly identify the issues at hand. Makes logical conclusions, anticipates obstacles, and considers different approaches to the decision-making process.
+ Provides guidance and acts as a resource for other analysts, project managers, and consultants
+ Actively participates in project, team, departmental and other meetings as required. Reports status updates, accomplishments, task and any barriers to manager.
+ Identifies and acts upon opportunities for continuous improvement.
+ Encourages prudent risk-taking, exploration of alternative approaches, and organizational learning.
+ Demonstrates personal commitment to change through actions and words. Mobilizes others to support change through times of stress and uncertainty.
+ Participates in the on-call responsibilities in support of a 24hrs/7days-production systems environment; acts as the primary support contact for the application's end-users
Qualifications
**The expertise and experiences youll need to succeed** **:**
**KNOWLEDGE AND SKILLS REQUIRED:**
+ Advanced of Microsoft suite of products
+ Extensive experience communicating complex technical concepts to a non-technical audience
+ Demonstrated creative problem-solving approach and strong analytical skills
+ Must have strong written and verbal communication skills
+ Knowledge of clinical/technical workflow
+ Work with minimal guidance
+ Rapid learner
**KNOWLEDGE AND SKILLS PREFERRED:**
+ 5 years of clinical or technical background
+ EMR application/implementation experience
**EDUCATION AND EXPERIENCE REQUIRED:**
+ College Degree (A.S, Diploma, B.A., B.S. or commensurate experience) in a field of study such as business, IS, or a healthcare related
+ Yearly participation in ongoing education either formal or through conferences, active professional organization participation, or journal presentations Required
+ Experience in Epic Beacon build, with a focus on oncology protocols and research workflow support.
**EDUCATION AND EXPERIENCE PREFERRED:**
+ College Degree (AS, Diploma, B.A., B.S.)
**LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:**
Epic Certification or ability to complete within 3 months of completing classes
Maintenance of current licensure or certification related to area of specialty (OT, PT, SLP, RN, RPH, RT, ARRT, etc.)
**LICENSURE, CERTIFICATION OR REGISTRATION Preferred:**
+ Epic Beacon Certification (current or past).
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.
**Category:** Information Systems
**Organization:** AdventHealth Information Technology
**Schedule:** Full-time
**Shift:** 1 - Day
**Req ID:** 25026487
We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.