• Strong organizational and planning skills to maintain a busy and diverse work schedule
• Proactive approach with the ability to work autonomously
• Excellent problem-solving skills
• The ability to multi-task and work well within a high-paced pressurized environment
• The ability to use your initiative to deliver a great customer experience
• Excellent communication skills paired with the ability to develop and nurture relationships
• Intermediate/Advanced IT skills including experience of using Word, Excel, Outlook and PowerPoint
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals
• Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
• Critical thinker and problem solver
• Excellent interpersonal skills, detail-oriented and meticulous
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• High level of self-motivation and energy
• Excellent professional writing and communication skills
• Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals
• Ability to work evenings and weekends as needed
• Must have access to reliable transportation

Certifications/Licenses, Education, and Experience

• Bachelor’s Degree or equivalent professional experience
• Research Professional Certification
• A minimum of 5 years of clinical research experience
• A minimum of 3 years prior Clinical Research Coordinator experience
• Previous Research Site Management experience preferred
• Spanish fluency preferred

Front Desk Reception 

• Greet patients and visitors, answer incoming calls.
• Address patient inquiries and concerns with professionalism, empathy, and discretion; escalate complex cases to appropriate clinical or operational leadership as needed

Administrative Support 

• Maintain accurate site calendars and patient visit diaries, ensuring alignment across investigators, coordinators, and site staff.
• Coordinate, schedule, confirm, and reschedule patient visits in alignment with protocol requirements and site capacity
• Support patient use of study-related applications, diaries, and required documentation as required if delegated on the study
• Perform day-to-day administrative tasks to support smooth site operations, including documentation preparation, filing, and record maintenance
• Prepare visit-specific materials, documents, and devices in accordance with visit schedules and study protocols supporting site operations
• Ensure accurate registration of appointments and timely updates in operational systems
• Work closely with investigators and site staff to ensure seamless patient flow and visit execution
• Build and maintain strong relationships with patients to support retention and a positive site experience
• Assist with scheduling, filing, and general office management. Prepare documents, reports, and forms to support site operations and clinical trial compliance.

Knowledge, Skills, and Abilities:

• Ability to communicate and work effectively with a diverse team of professionals 
• Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments 
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, patients, and vendors 
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals 
• Strong computer skills with demonstrated abilities using clinical trials database, MS word and excel 
• Ability to balance tasks with competing priorities 
• Critical thinker and problem solver 
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done 
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure 
• High level of self-motivation, energy and possess a high degree of urgency.  
• Ability to work independently in a fast-paced environment with minimal supervision 
• Ability to adapt to changes in responsibilities and workloads.  
• Must have a patient service mentality 
• Must be Bilingual in Spanish

Certifications/Licenses, Education, and Experience

Minimum requirement: GED or high school diploma.

• Prior experience in healthcare, clinical trials, or administrative office work preferred.
• 2+ years of experience in patient services, clinical coordination, or a healthcare-related role. Experience in clinical trials or research setting is preferred.
• Understanding of HIPAA and patient privacy standards.
• Experience utilizing technology (electronic scheduling systems)
• Knowledge of Microsoft tools (Excel, Word, PowerPoint, Outlook, ...)

How You'll Make An Impact

• Patient Coordination 
  • Prioritize activities with specific regard to protocol timelines  
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.  
  • Maintain effective relationships with study participants and other care Access Research personnel.  
  • Balances protocol needs with patient experience; proactively addresses concerns. 
  • Monitors quality metrics; prevents deviations; resolves queries quickly. 
  • Interact in a positive, professional manner with patients, .representatives, investigators and Care Access Research personnel and management.  
  • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.  
  • Mentors CRC I peers; provides onboarding and day‑to‑day guidance. 
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  
  • Moderate complexity; mixed visit types, active IP and AE/SAE workflows. 
  • Can operate as solo CRC onsite. 
  • Prescreen study candidates   
  • Obtain informed consent per Care Access Research SOP .  
  • Complete visit procedures in accordance with protocol.  
  • Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.  
  • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.  
  • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.  

• Documentation 
  • Record data legibly and enter in real time on paper or e-source documents   
  • Accurately record study medication inventory, medication dispensation, and patient compliance.  
  • Resolve data management queries and correct source data within sponsor provided timelines  
  • Assist regulatory personnel with completion and filing of regulatory documents.  
  • Assist in the creation and review of source documents.  

• Patient Recruitment 
  • Assist with planning and creation of appropriate recruitment materials.  
  • Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.  
  • Actively work with recruitment team in calling and recruiting subjects   

• Review and assess protocol (including amendments) for clarity, logistical feasibility 
• Ensure that all training and study requirements are met prior to trial conduct.  
• Communicate clearly verbally and in writing.  
• Anticipates needs; proposes solutions; manages change effectively. 
• Attend Investigator meetings as required.   
• Owns studies; prioritizes competing demands; mentors CRC I. 
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)  

The Expertise Required

• Bilingual in Spanish required
• Ability to understand and follow institutional SOPs.  
• Excellent working knowledge of medical and research terminology  
• Excellent working knowledge of federal regulations, good clinical practices (GCP)  
• Operates independently for most study activities; escalates complex issues as needed. 
• Ability to communicate and work effectively with a diverse team of professionals.  
• Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail  
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.  
• Critical thinker and problem solver  
• Friendly, outgoing personality; maintain a positive attitude under pressure.  
• High level of self-motivation and energy  
• Excellent professional writing and communication skills  
• Manages stakeholder communications; facilitates visits and meetings. 
• Ability to work independently in a fast-paced environment with minimal supervision.  

• Work closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable.
• Attends and participates in meetings with the director, other managers, and staff as necessary.
• Complies with regulatory requirements, policies, procedures, and standards of practice.
• Read and understand the informed consent form, protocol, and investigator's brochure.
• Be available to see subjects virtually or in-person as dictated by project design, answer their questions, and resolve medical issues during the study visit.
• Sign and ensure that the study documentation for each study visit is completed.
• Perform all study responsibilities in compliance with the IRB approved protocol.
• Administration of Investigational Products (via subcutaneous, transdermal, intramuscular, intravenous, or oral routes).
• Proficiency in starting, monitoring, and maintaining intravenous lines.
• Proficiency in phlebotomy, proper blood collection practices, and laboratory processing practices (can be learned)
• Contribute as an active member of clinicians involved in the management of infusion or other investigational product related reactions.
• Maintain a clean, efficient clinical area to assure the highest standards of patient care.
• Follow safety and PPE procedures as well as maintain proper documentation of infusion procedures.
• Timely communications with internal teams, investigators, review boards, and study subjects
• Perform trial procedures as per delegation which can include the following but not limited to:
• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment.
• Obtain informed consent per SOP.
• Administer delegated study questionnaires, as appropriate.
• Collect and evaluate medical records.
• Complete visit procedures and ensure proper specimen collection, processing, and shipment in accordance with protocol.
• Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Review screening documentation and approves subjects for admission to study.
• Review admission documentation and approves subject for randomization.
• Provide ongoing assessment of the study subject/patient to identify Adverse Events.
• Ensure that serious and unexpected adverse events are reported promptly to the Pl.
• Review and evaluates all study data and comments to the clinical significance of any out-of-range results.
• Perform physical examinations as part of screening evaluation and active study conduct.
• Provide medical management of adverse events as appropriate.
• Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
• Monitor patient progress on study medication.
• Other duties as assigned.

• Ability to check, perform, and document vitals as well as EKG (ECG)
• Phlebotomy and expert IV skills
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals.
• Strong organizational skills: Able to prioritize, support, and follow through on assignments with good understanding of medical terminology.
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors.
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors.
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
• Ability to balance tasks with competing priorities.
• Critical thinker and problem solver.
• Curiosity and passion to learn, innovative, and able to take thoughtful risks while communicating concerns and mitigations.
• Good management and organizational skills, understanding of medical procedures.
• Exceptional interpersonal skills, willingness to the ability to work independently.
• Ability to lift a minimum of 50 pounds.
• Command of professional and Business English (written and spoken).
• You must have the authorization to work in the US for any employer.
• You must not need visa sponsorship, either now or in the future.
• You must live in the USA and be willing and able to travel with 24–36-hour notice

• At least Master’s Level Science Degree. Nurse Practitioner or Physician Assistant with 5+ years of clinical experience.
• Clinical Practice Experience Desired with Infusion Skillset.
• Currently licensed in good standing in one or more states.
• A minimum of 1 year of relevant work experience as Sub-Investigator (preferred) in a Clinical Research setting.
• Preferred at least one (1) year of experience as a Clinical Research Coordinator or willingness to learn.