Doris Caldwell Email & Phone Number

Hickory, North Carolina, United States

•Responsible for recruiting, scheduling, and performing procedures according to protocol specified schedule of assessment.•Execute the informed consent process while supporting the standards of good clinical practice.•Maintain source documentation, ensuring quality control of data and data entry to eCRFs.•Perform clinical procedures including venipuncture, vital signs, body measurements, DEXA scan and ECG’s.•Thoroughly discuss and document possible adverse events with study subjects.•Oversee the supply, distribution and subject compliance of investigational product and study supplies.•Regularly communicate with study teams via phone and email.•Maintain and systemize study regulatory documents.•Organize and submit reports and memos to the International Review Board.•Prepare and perform monitor, sponsor, and auditor visits.

Chapel Hill, North Carolina, United States

•Responsible for the recruitment, screening, eligibility, consenting and registration of patients across multiple complex clinical trials in the Phase I disease group.•Screened for eligibility by reviewing medical record source documents, inclusion/exclusion criteria, and subjects' willingness and capability to follow required clinical research procedures, processes, and follow up appointments.•Ensured compliance with protocol requirements, federal regulations, ICH-GCP guidelines while coordinating patient visits, assessing Adverse Events/Dose-Limiting Toxicities, reviewing concomitant medications and investigational Product compliance.•Processed and submitted patient travel/expense reimbursements.•Tracked and reported adverse events, serious adverse events, protocol waivers, deviations, and violations; participated in pre-study, initiation, monitoring and close out visits.•Reviewed dosing instructions for investigational drugs with patients and assessed for compliance through the review of pill diaries and counting of returned Investigational Product.•Scheduled patients for research-related study visits and contacted patients for clinical follow-up requirements.•Collected, processed, packaged, and shipped study specimens according to study protocol(s); ensured that research lab kits and other study specific supplies were ordered as appropriate.•Facilitated training and education of study team members, including protocol specific training, throughout the life of the clinical trial.•Served as preceptor for new hires; provided ongoing training and subject matter support.•Communicated with study sponsors and monitors regarding study updates and queries promptly.•Understood and followed policies, standard operating procedures, regulations, and protocol requirements that govern clinical research. Maintained UNC and project specific training and certification requirements.

Cary, North Carolina, United States

•Responsible for the recruitment, screening, eligibility, consenting and registration of patients across multiple complex clinical trials in the Phase One disease group.•Ensured compliance with protocol requirements, federal regulations, ICH-GCP guidelines while coordinating patient visits, assessing Adverse Events/Dose-Limiting Toxicities, reviewing concomitant medications and lnvestigational Product compliance. •Processed and submitted patient travel/expense reimbursements.•Reviewed dosing instructions for investigational drugs with patients and assessed for compliance through the review of pill diaries and counting of returned lnvestigational Product.•Ensured that research lab kits and other study specific supplies were ordered as needed.•Facilitated training and education of study team members, including protocol specific training, throughout the life of the clinical trial.•Followed policies, standard operating procedures, regulations, and protocol requirements that govern clinical research. Maintained UNC and project specific training and certification requirements.•Updated clinical trial management system for accurate reporting to IRB, DSMC, and other regulatory authorities; used electronic medical record system to review patient medical records and managed clinical research processes.•Used Electronic Data Capture systems and entered data accurately; detected issues related to data capture, collection or management and suggested solutions

Durham, North Carolina, United States

•Employed strategies to support recruitment and retention rates and assisted participants with individual needs. Collected information to determine appropriate study feasibility, recruitment, and retention strategies. Evaluated processes to identify issues related to recruitment and retention rates.•Worked closely with the Principal Investigator and study team to recruit, screen and enroll participants for complex research studies; conducted and documented consent for study participants; scheduled participants for research visits and conducted and documented each visit.•Coordinated study activities with teammates and colleagues to successfully implement and conduct the study; recognized and offered solutions to study problems; escalated issues appropriately; took part in site initiation and closeout visits; aided in the development of novel studies.•Maintained study compliance with institutional requirements and policies; maintained study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record; recorded adverse events and reported promptly; oversaw maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.•Followed procedures and documentation of study payment and participant care expenses in a timely fashion; monitored financial study milestones and reported appropriately; coordinated with financial teams and took part in budget development; helped with study budgets and closeouts.•Served as primary liaison with sponsors, study personnel and Pl for assigned studies; collaborated, and communicated with other study personnel as needed; communicated concerns professionally; promptly responded to emails, phone calls and questions.•Used Electronic Data Capture systems and entered data accurately; detected issues related to data capture, collection or management and suggested solutions.

Miami, Florida, United States

•Recruited, screened, enrolled, and obtained informed consent.•Assisted in the preparation of IRB documents and reports; ensured compliance with relevant IRB policies and regulatory agency requirements.•Coordinated day-to-day aspects of study related procedures, including, but not limited to scheduling visits and procedures, data entry, specimen collection, research visit documentation, maintenance of regulatory binders and study files, creation and maintenance of source documentation, preparation for monitoring visits, site initiation/closeout visits and audits; filed all correspondence in Investigator Site File; processed and prepared specimens for shipment or storage; ordered and maintained study equipment and supplies.•Communicated protocol amendments to team members and ensured training completion. •Consulted with other departments to schedule procedures for study participants including the research pharmacy, radiology, laboratory services, Ophthalmic Services, and surgical center.•Delivered study goals as they specifically related to each protocol: Pre-Study Requirements, Study Feasibility, Subject recruitment and retention, Collection and submission of regulatory documents, IRB/IEC communication, Compliance to GCP, ICH, and local and client requirements. •Reported and documented Adverse Events and Serious Adverse Events according to all applicable international, local, and sponsor requirements.•Collaborated with Investigators and clinical personnel to screen for eligible study subjects by assessing the inclusion/exclusion criteria of study protocols.Performed informed consent process with potential study subjects, explained protocols, answered questions, and fulfilled regulatory requirements for Informed Consent Form and HIPAA authorization.•Coordinated domestic & international travel for patients; processed travel/expense reimbursement.•Organized and assisted with multi luminance mobility testing for visually impaired research participants.

Miami, Florida, United States

•Coordinated and managed a variety of community research projects, and community programs focused on advancing the knowledge of improving the lives of older adults and their families.•Oversaw recruitment, retention, screening and eligibility of research participants and study partners, particularly in underserved minority aging populations.•Developed and implemented an effective program of outreach to attract potential clients to research programs.•Organized, hosted, and took part in community education and outreach activities to increase research enrollment of underserved diverse aging populations who are historically underrepresented in medical research.•Built collaborations with key community partners including public health agencies, community corporations and faith-based organizations.•Conducted meetings with research staff, and ensured functions were coordinated in a prompt and accurate manner according to established guidelines; monitored and ensured good data acquisition and data management processes.•Performed neurocognitive assessments to measure brain functioning in research patients.•Assisted principal investigator in the development and revision of study protocol and data collection processes.•Screened and enrolled research participants; collected medical and social histories from participants; scheduled subject visits/procedures consistent with protocol requirements.•Monitored participant progress and documented problems and inconsistencies, and recommended corrective actions as appropriate; ensured data integrity across electronic and hard copy records.•Provided researchers and relevant stakeholders with ongoing updates about project progress, successes, challenges, and data needs.•Consented and enrolled research subjects while adhering to Good Clinical Practice and study protocols; ensured that adverse events and serious adverse events were properly documented and reported.

Miami, Florida, United States

•Assisted principal investigator in providing the patient and family with a thorough description of research treatments and side effects related to study treatment; recruited, screened, enrolled, and obtained consent from study participants.•Ensured study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents; entered required research data into Velos database.•Took part in pre-study, initiation, monitoring and close out visits; completed corrections/queries related to study and site initiation visits.•Helped principal investigator assess enrollment feasibility; assured that all study eligibility forms were completed and submitted for proper review.•Ensured that randomization and study registration of patients were performed in compliance with departmental policies, UM policies and federal regulations.•Communicated with patients to assure adherence to research protocol(s); tracked patients return clinic visits to obtain required research specimens.•Delivered research specimens to proper labs in a prompt fashion.•Reviewed medical records to obtain pertinent patient data including vital signs, height/weight, temperature, respiratory rate, oxygen saturation level and blood pressure.•Maintained up-to-date reports of laboratory results and changes in treatment plan.•Maintained correct record of study medications and concomitant medications as per study protocol.•Ensured that research lab kits and other study specific supplies were obtained/ordered as appropriate.•Maintained study logs including, but not limited to screening, enrollment, deviations, concomitant medication, adverse events, tumor measurement, delegation and other sponsor or protocol specific logs.•Worked with study data manager to ensure case report forms were entered into the right computer database.•Attended site disease group meetings, tumor board meetings, and departmental meetings.

Miami, Florida, United States

•Identified and built collaborations with key community partners (e.g., including academic institutions, public health agencies and community and faith organizations) to serve the medically underserved.•Organized community outreach events and screened potential study subjects using clinical assessments to measure basic physical and cognitive functions.•Assisted principal investigators in the development and revision of study protocols and data collection processes, served as team lead for the dementia clinical research group.•Obtained and tracked hazardous biological samples and medical/social histories from study participants; monitored study needs; recruited and interviewed potential study participants.•Monitored patients' progress to identify and document problems and/or inconsistencies, recommended corrective actions as appropriate; documented adverse events.•Took part in ongoing consensus diagnostic meetings to ensure integrity of case definition.•Developed data case report forms, questionnaires, manual of procedures for data collection and coding.•Ensured data integrity by adhering to established quality management practices.•Ordered and kept medical research supplies and equipment for all clinical research teams.•Assisted with publications, presentations, and dissemination of research findings in communities, peer reviewed journals, at professional meetings, and other appropriate venues.•Provided ongoing updates about the study progress, successes, challenges, and data needs.

Durham, North Carolina, United States

• Recruited, screened, enrolled, and obtained consent from study participants. • Trained fellow study coordinators within the United States and conducted domestic and international workshops and seminars to train study coordinators on ethical practices of the informed consent process in clinical research. • Developed protocols for clinical research studies and recommended modifications via protocol amendments submitted to Institutional Review Board (IRB). • Created abstracts and summaries presented at scientific meetings and for publication of results. • Managed various projects and executed strategies for recruiting study subjects in genetic research studies. • Retrieved medical records; performed routine blood drawing procedures; identified and resolved missing or ambiguous data; and managed confidential patient/subject information under established HIPAA guidelines. • Recommended new methods for collection and documentation of research data and ensured data integrity within database. Generated queries in SQL based database and produced reports for statistical analysis. • Prepared specimen sampling kits for study subjects and tracked blood samples from various study sites.