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
Birmingham, AL
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
Birmingham, AL
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
Pell City, AL
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
Birmingham, AL
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
Moody, AL
12.1998 - 12.2010
Senior Clinical Research Coordinator
Clinical Research Center
Birmingham, AL
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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