Jessica Wallan

• Participants in meetings with Duke and the NIH representatives
• Review and comment on suggestions on patient-facing materials, supplies for the protocols, pre-screening questionnaires, and other study-specific materials
• Consulting on multiple protocols.

• Duties include managing multiple coordinators as well as the PIs, Sub-Is, and pharmacists
• Responsible for all the duties of a clinical research coordinator
• Currently managing 20-plus clinical trials as the regulatory and primary or backup study coordinators
• Regulatory compliance and creation of regulatory binders
• Supply ordering for individual studies and office supplies
• Site feasibility
• Creating and updating FDA Form1572’s
• Creation of staff CV’s
• Facilitating training for new staff, including PI’s, Sub-I’s, and Coordinators
• Train new staff members on site SOPs and study specifics protocols
• IRB submissions, FDA submissions
• Quality control of all investigator site binders and subject binders
• Creating and assisting with invoice submission.
• Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
• Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
• Monitored office workflow and administrative processes to keep operations running smoothly.
• Evaluated company documentation to verify alignment with regulatory requirements.
• Assisted in recruiting, hiring and training of team members.

• Duties included the creation of source documentation, conducting subject visits, and lab collection
• Ensured site readiness for audits and inspections by maintaining a well-organized, detailed, and accurate study documentation system.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Followed informed consent processes and maintained records.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Streamlined data collection processes for increased efficiency and accuracy in study results.
• Gathered, processed, and shipped lab specimens.
• Enhanced patient enrollment by implementing efficient recruitment strategies and streamlining the screening process.
• Improved data quality by conducting thorough source document verification and ensuring accurate data entry in electronic case report forms.
• Coordinated successful clinical trials by maintaining regular communication with study sponsors, investigators, and research staff.
• Increased protocol compliance by providing comprehensive training and support to study team members.
• Maintained high ethical standards in research practices, adhering to Good Clinical Practice guidelines and safeguarding patient rights.
• Streamlined regulatory submissions by efficiently preparing documentation, including informed consent forms, serious adverse event reports, and institutional review board materials.
• Expedited site initiation visits by working collaboratively with sponsors to ensure all necessary requirements were met prior to study commencement.
• Supported positive relationships between patients and research teams through empathetic communication and compassionate care coordination efforts during clinical trials participation.
• Facilitated rapid resolution of complex issues related to study conduct or patient safety concerns through effective problem-solving skills.
• Prioritized participant safety within clinical trials environment via rigorous adverse event reporting procedures compliant with industry regulations.
• Developed strong professional connections among colleagues working together as a cohesive team producing high-quality results.
• Screened physician referrals to identify prospective candidates for research studies.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• IV placement when needed
• IP accountability

· Improved patient comfort by providing efficient and gentle blood draw techniques.

· Addressed questions and concerns to educate patients on collection process and procedures.

· Exhibited professionalism under pressure when dealing with difficult patients or situations, maintaining composure and focusing on task completion.

· Maintained a clean and sterile work environment, adhering to strict infection control protocols.

· Contributed to patient safety by consistently using proper needle disposal methods, minimizing risk of injury or contamination.

· Assisted in training new phlebotomists on proper blood collection procedures, contributing to a skilled and cohesive team.

· Collaborated with office staff for seamless scheduling of patients, reducing wait times and optimizing workflow.

· Ensured accurate test results by strictly following protocol for specimen handling and storage.

· Supported diagnostic processes by proficiently collecting various types of specimens beyond blood, such as urine or saliva samples.

· Developed strong rapport with patients through compassionate care and empathetic communication during potentially stressful procedures.

· Demonstrated adaptability by successfully performing venipuncture on patients with challenging vein conditions, ensuring minimal discomfort while obtaining necessary samples.

· Managed inventory levels for supplies needed in daily operations, keeping track of stock usage to ensure uninterrupted provision of services for patients'' needs.

· Collaborated effectively with physicians and nurses regarding specific patient needs or concerns during sample collection processes.

· Demonstrated versatility by performing both capillary and venous blood collection techniques as needed for specific patients or tests.

· Established and maintained positive working relationships with patients, staff and clinical personnel to build trust and camaraderie.

· Used personal protective equipment correctly to protect coworkers and patients.

· Centrifuged blood samples as outlined in clinical protocols.

· Assembled tourniquets, needles, and blood collection devices to prepare work trays.

· Tracked collected specimens by initialing, dating, and noting times of collection.

· Reviewed patient records for accuracy and completeness.

· Packaged and shipped specimens to central lab daily.

· Monitored patients for reactions and verified sample quality.

· Participated in continuing education programs to stay up to date on new technologies and procedures.

· Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles, and straight needles.

· Verified patients' identification for proper sample collection.

· Collected blood samples in accordance with laboratory protocols and regulations.

· Adhered to HIPAA standards and maintained patient confidentiality in all interactions.

· Reviewed and processed requisitions for laboratory tests.

· Validated blood and specimen collection orders, alerting nurses, or physicians of discrepancies between order and nursing station logs.

· Participated in quality assurance and competency assessment initiatives.

• Duties included the creation of source documentation, conducting subject visits, and lab collection
• Ensured site readiness for audits and inspections by maintaining a well-organized, detailed, and accurate study documentation system.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Followed informed consent processes and maintained records.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Gathered, processed, and shipped lab specimens.
• Enhanced patient enrollment by implementing efficient recruitment strategies and streamlining the screening process.
• Improved data quality by conducting thorough source document verification and ensuring accurate data entry in electronic case report forms.
• Coordinated successful clinical trials by maintaining regular communication with study sponsors, investigators, and research staff.
• Increased protocol compliance by providing comprehensive training and support to study team members.
• Maintained high ethical standards in research practices, adhering to Good Clinical Practice guidelines and safeguarding patient rights.
• Streamlined regulatory submissions by efficiently preparing documentation, including informed consent forms, serious adverse event reports, and institutional review board materials.
• Expedited site initiation visits by working collaboratively with sponsors to ensure all necessary requirements were met prior to study commencement.
• Supported positive relationships between patients and research teams through empathetic communication and compassionate care coordination efforts during clinical trials participation.
• Facilitated rapid resolution of complex issues related to study conduct or patient safety concerns through effective problem-solving skills.
• Prioritized participant safety within clinical trials environment via rigorous adverse event reporting procedures compliant with industry regulations.
• Developed strong professional connections among colleagues working together as a cohesive team producing high-quality results.
• Screened physician referrals to identify prospective candidates for research studies.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• IV placement when needed
• IP accountability
• Streamlined data collection processes for increased efficiency and accuracy in study results.

· Improved patient comfort by providing efficient and gentle blood draw techniques.

· Addressed questions and concerns to educate patients on collection process and procedures.

· Exhibited professionalism under pressure when dealing with difficult patients or situations, maintaining composure and focusing on task completion.

· Maintained a clean and sterile work environment, adhering to strict infection control protocols.

· Contributed to patient safety by consistently using proper needle disposal methods, minimizing risk of injury or contamination.

· Assisted in training new phlebotomists on proper blood collection procedures, contributing to a skilled and cohesive team.

· Collaborated with office staff for seamless scheduling of patients, reducing wait times and optimizing workflow.

· Ensured accurate test results by strictly following protocol for specimen handling and storage.

· Supported diagnostic processes by proficiently collecting various types of specimens beyond blood, such as urine or saliva samples.

· Developed strong rapport with patients through compassionate care and empathetic communication during potentially stressful procedures.

· Demonstrated adaptability by successfully performing venipuncture on patients with challenging vein conditions, ensuring minimal discomfort while obtaining necessary samples.

· Managed inventory levels for supplies needed in daily operations, keeping track of stock usage to ensure uninterrupted provision of services for patients'' needs.

· Collaborated effectively with physicians and nurses regarding specific patient needs or concerns during sample collection processes.

· Demonstrated versatility by performing both capillary and venous blood collection techniques as needed for specific patients or tests.

· Established and maintained positive working relationships with patients, staff and clinical personnel to build trust and camaraderie.

· Used personal protective equipment correctly to protect coworkers and patients.

· Centrifuged blood samples as outlined in clinical protocols.

· Assembled tourniquets, needles, and blood collection devices to prepare work trays.

· Tracked collected specimens by initialing, dating, and noting times of collection.

· Reviewed patient records for accuracy and completeness.

· Packaged and shipped specimens to central lab daily.

· Monitored patients for reactions and verified sample quality.

· Participated in continuing education programs to stay up to date on new technologies and procedures.

· Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles, and straight needles.

· Verified patients' identification for proper sample collection.

· Collected blood samples in accordance with laboratory protocols and regulations.

· Adhered to HIPAA standards and maintained patient confidentiality in all interactions.

· Reviewed and processed requisitions for laboratory tests.

· Validated blood and specimen collection orders, alerting nurses, or physicians of discrepancies between order and nursing station logs.

· Participated in quality assurance and competency assessment initiatives.

· Improved patient comfort by providing efficient and gentle blood draw techniques.

· Addressed questions and concerns to educate patients on collection process and procedures.

· Exhibited professionalism under pressure when dealing with difficult patients or situations, maintaining composure and focusing on task completion.

· Maintained a clean and sterile work environment, adhering to strict infection control protocols.

· Contributed to patient safety by consistently using proper needle disposal methods, minimizing risk of injury or contamination.

· Assisted in training new phlebotomists on proper blood collection procedures, contributing to a skilled and cohesive team.

· Collaborated with office staff for seamless scheduling of patients, reducing wait times and optimizing workflow.

· Ensured accurate test results by strictly following protocol for specimen handling and storage.

· Supported diagnostic processes by proficiently collecting various types of specimens beyond blood, such as urine or saliva samples.

· Developed strong rapport with patients through compassionate care and empathetic communication during potentially stressful procedures.

· Demonstrated adaptability by successfully performing venipuncture on patients with challenging vein conditions, ensuring minimal discomfort while obtaining necessary samples.

· Managed inventory levels for supplies needed in daily operations, keeping track of stock usage to ensure uninterrupted provision of services for patients'' needs.

· Collaborated effectively with physicians and nurses regarding specific patient needs or concerns during sample collection processes.

· Demonstrated versatility by performing both capillary and venous blood collection techniques as needed for specific patients or tests.

· Established and maintained positive working relationships with patients, staff and clinical personnel to build trust and camaraderie.

· Used personal protective equipment correctly to protect coworkers and patients.

· Centrifuged blood samples as outlined in clinical protocols.

· Assembled tourniquets, needles, and blood collection devices to prepare work trays.

· Tracked collected specimens by initialing, dating, and noting times of collection.

· Reviewed patient records for accuracy and completeness.

· Packaged and shipped specimens to central lab daily.

· Monitored patients for reactions and verified sample quality.

· Participated in continuing education programs to stay up to date on new technologies and procedures.

· Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles, and straight needles.

· Verified patients' identification for proper sample collection.

· Collected blood samples in accordance with laboratory protocols and regulations.

· Adhered to HIPAA standards and maintained patient confidentiality in all interactions.

· Reviewed and processed requisitions for laboratory tests.

· Validated blood and specimen collection orders, alerting nurses, or physicians of discrepancies between order and nursing station logs.

· Participated in quality assurance and competency assessment initiatives.