MELISSA KITTS
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
26
26
years of professional experience
Work History
Clinical Research Coordinator
Retina Consultants of Alabama
09.2024 - Current
- Following clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screening patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathering, processing, and shipping lab specimens.
- Enhancing patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Following informed consent processes and maintained records.
- Collaborating with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinating and monitored clinical trial activities to support timely and accurate completion of studies.
- Working with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Assessing patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Maintaining compliance with protocols covering patient care and clinical trial operations.
- Preparing and maintaining regulatory documents for clinical trial submissions.
- Collecting data and followed research protocols, operations manuals, and case report form requirements.
- Managing study budgets and resources to maximize return on investment while maintaining quality standards.
- Managing study budget effectively, minimizing unnecessary expenses and allocating funds wisely.
- Streamlining patient visit schedules, reducing wait times and increasing patient satisfaction.
- Negotiating contracts with vendors for trial supplies, ensuring cost-effective resource allocation.
- Reviewing referral information and kept track of intakes from various referral sources.
- Dispensing investigational product
Clinical Trials Administrator II
University Of Alabama At Birmingham
05.2019 - Current
- Performs sponsor required protocol driven data collection and data entry for multiple research projects
- Verifies Inform Consent Forms for accuracy
- Performs protocol specific procedures such as shipping of lab samples
- Support project leads in preparing regulatory document's for continue review and study closure through WIRB and Advarra
- Keep track of lab inventory using an excel spreadsheet
- Schedule all monitors and sponsors for Site, Close Out and Monitoring visits
- Assist with regulatory items and serve as a back-up for Clinical Trial Administrator
- Complete and track department deposits
- Complete and track sponsor payments
- Maintain all Financial Tracking logs for Trials
- Invoice for all sponsor industry trials
- Perform payment request through the Greenphire system for patient participation
- Ensure all financial aspects of a project are completed in a timely manner so that clinical trial agreements can be submitted to OSP
- Complete payment request through Oracle
- Query resolution
- Maintain and register receipt of investigational product
- Review and file newsletters and labs
- Handled sensitive information discreetly, maintaining strict confidentiality at all times as required by company policy or legal regulations.
- Maintained personnel records and updated internal databases to support document management.
- Organized workflow and delegated tasks effectively to ensure timely project completion without compromising quality.
- Managed office inventory levels, ensuring adequate supplies were available while minimizing waste and unnecessary spending.
- Maintained accurate documentation of company policies and procedures for easy reference by all employees.
- Improved employee productivity with effective time management strategies for daily tasks.
- Served as a liaison between departments, fostering open communication channels that improved overall organizational function.
- Reduced overhead costs through careful budget management and resource allocation.
- Coordinated with IT department to upgrade software, ensuring all systems were up-to-date and running efficiently.
- Developed and maintained up-to-date database of contacts, facilitating quick and efficient communication.
- Managed scheduling for executive staff to ensure optimal time management and productivity.
- Oversaw maintenance of office equipment, minimizing downtime due to malfunctions or repairs.
- Negotiated with vendors to secure more favorable terms, resulting in cost savings for office expenses.
- Collected, arranged, and input information into database system.
- Gathered, organized and input information into digital database.
Office Manager for Satellite Office
Alabama Oral And Facial Surgery
02.2013 - 05.2019
- Monitored multiple databases to keep track of all company inventory
- Organized and scheduled meetings and appointments
- Point person for maintenance, ordering, mailing, shipping, supplies, equipment and errands
- Provided support and resolved issues with staff and patients
- Responsible for recruiting and training staff
- Allocated tasks and assignments to subordinates and monitored their performance
- Networked with local dentist to become new referrals
Research Specialist
University Of Alabama At Birmingham
02.2012 - 02.2013
- Prepared summaries of research findings and effectively presented them to supervisors
- Entered data into digitize records and streamline research procedures
- Verified data before entering it into database to ensure accuracy
- Traveled to field sites to collect and record data useful for study purposes
- Developed and maintained databases, pulling relevant data as needed
- Participated in weekly meetings, took copious notes for all attendees and distributed details to relevant stakeholders
- Screened potential subjects to determine suitability for studies
- Managed critical paperwork such as informed consent forms and personal waivers
- Obtained data from various sources, including patient medical records and surveys
- Supported project leads in preparing regulatory documentation and presentations highlighting findings
- Directed clients to appropriate personnel to address concerns, resolve complaints or answer account-related questions
- Sorted and distributed business correspondence to correct department or staff member, reducing dropped communications and enabling faster responses to key requests
- Managed and anticipated clerical needs of company employees, including copying, faxing and file management
- Sort incoming mail and directed to correct personnel each day
- Communicate with vendors to place and receive orders, request maintenance services and deliver instruction on behalf of office management
Receptionist
Independent Research Consultant
12.1998 - 12.2010
Senior Clinical Research Coordinator
Clinical Research Center
06.2004 - 12.2008
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants
- Managed clinical research trials involving dialysis patients
- Recruited volunteers for studies
- Adhered to standards in all areas, including data collection, research protocols and regulatory reporting
- Collected, processed and delivered specimens from trial participants
- Conducted informed consent presentations and maintained documentation
- Kept patient care protocols and clinical trial operations in compliance
- Obtained informed consent from research subjects and guardians to explain possible side-effects and potential outcomes of research
- Monitored multiple databases to keep track of all company inventory
- Performed Study procedures such as ECG's, processing and shipping of lab specimens
- Prepared source documents
- Entered Data in EDC for multiple research projects
- Maintained required records of study activity including CRF's, drug logs and regulatory forms
- Dispensed investigational product
- Scheduled patients for each clinical visit
- Instructed research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures and documentation procedures
- Prepare, compiled and filed documents as well as reports presented to various parties
- Organize and update daily/weekly schedules as well as monthly calendar obligations for various levels of management and staff
- Meet incoming patients with professional approach and provided friendly, knowledgeable assistance
- Take accurate messages for staff and management to facilitate speedy communication
- Provide clerical support to all team members to improve office efficiency and enhance productivity
- Complete all CDA´s via expedited checklist for OSP review
Education
Diploma - Medical Billing & Coding
Virginia College - Birmingham
Birmingham, AL10.2004
High School Diploma -
Moody High School
Moody, AL05.1989
Skills
- Data collection and analysis
- Proficiency in Inform and Medidata EDC
- Database administration
- Laboratory assistance
- Resolving discrepancies
- Contract negotiation
- Time management skills
- Organizational skills
- Interpersonal skills
- Good Clinical Practices
- Electronic Data Capture
- Adverse event reporting
- Informed consent
- Study protocols
Locations
- University Of Alabama At Birmingham, Birmingham, AL
- Alabama Oral And Facial Surgery, Pell City, AL
- Dr. Christopher Rothman, Pell City, AL
- Clinical Research Center, Birmingham, AL
- Moody, Moody, AL
- Virginia College - Birmingham, Birmingham, AL
- Moody High School, Moody, AL
Timeline
Clinical Research Coordinator
Retina Consultants of Alabama
09.2024 - Current
Clinical Trials Administrator II
University Of Alabama At Birmingham
05.2019 - Current
Office Manager for Satellite Office
Alabama Oral And Facial Surgery
02.2013 - 05.2019
Research Specialist
University Of Alabama At Birmingham
02.2012 - 02.2013
Senior Clinical Research Coordinator
Clinical Research Center
06.2004 - 12.2008
Receptionist
Independent Research Consultant
12.1998 - 12.2010
High School Diploma -
Moody High School
Diploma - Medical Billing & Coding
Virginia College - Birmingham
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