Hi, I’m
Mary Allor
Richmond,TX
Summary
Highly meticulous Clinical Research Associate with a strong ability to oversee and organize various operational tasks, supervise sites effectively, and compile comprehensive clinical reports. Extensive expertise in the clinical trial process, ICH/GCPs, and FDA Regulations, complemented by a background in laboratory research regulatory compliance and program management. Proficient in action planning, maintaining database security, ensuring compliance with standard operating procedures, and managing programs. Committed to diligently monitoring and protecting the well-being and rights of clinical trial patients.
Overview
14
years of professional experience
Work History
PPD (part of Thermo Fisher Scientific)Wilmington, North Carolina
Senior Clinical Research Associate II
08.2022 - Current
Job overview
- Currently working on two protocols and effectively managing 13 sites.
- Conduct on-site and remote pre-study, site initiation, and Interim monitoring visits to ensure compliance with study protocols, regulatory requirements, and Standard Operating Procedures (SOPs
- Perform source data verification, reviewing case report forms for accuracy and completeness
- Collaborate with investigators, study coordinators, and sponsor representatives to address any issues or concerns related to the trial
- Ensure timely collection and submission of study documentation, including consent forms, investigator brochures, and regulatory submissions
- Monitor subject recruitment and retention to ensure enrollment targets are met within defined timelines.
- Improved clinical trial efficiency by streamlining data collection and management processes.
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
- Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
- Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
- Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
- Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Contributed to the development of study protocols, informed consent forms, and case report forms to ensure consistency across clinical trials.
- Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Parexel IncHackensack, NJ
Senior Clinical Research Associate
04.2020 - 07.2022
Job overview
- Participated in sponsor and investigator/ initiation meetings
- Scheduled and successfully conducted over 15 PSSVs, 8 SIVs, >100 IMVs and COVs in a timely manner
- Efficiently handled and supervised 10 sites simultaneously with effective management skills.
- Ensuring reports and training were completed and submitted in a timely manner
- Ensuring study supplies (e.g Lab kits) were available on site
- IP accountability/ inventory, security, dispensation, return and destruction (where applicable) were in compliance with protocol/ site SOP
- Performing site evaluation visits of potential investigators and evaluated the capability of the site to successfully manage and conduct the clinical study
- Preparing accurate and timely trip reports
- Ensuring the study staff who will conduct the protocol had received the proper materials and instructions to safely enter patients into the study
- Assisting in drafting study-related plans
- Reviewing participant eligibility and documentation of consent
- Monitoring the collection, accuracy and integrity of regulatory documents in the site binder
- Evaluating electronic data capturing systems for adherence to guidelines
- Checking drug storage procedures for compliance with protocols and SOP requirement.
- Improved clinical trial efficiency by streamlining data collection and management processes.
- Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
Parexel IncHackensack, NJ
Clinical Research Associate1
11.2018 - 03.2020
Job overview
- Conducts site selection, site initiation, to routine monitoring and close-out visits at Investigative sites to assess protocol, regulatory and ICH-GCP compliance
- Ensuring the subject enrollment, advertising for the study, ICF process, reviewing EDC against source data such as patient diaries, laboratory results, scans etc
- Ensures all the essential documents are maintained in the investigator site folder and is updated with new or amended documents and essential documents are forwarded to the sponsor for updating the TMF as necessary
- Assure timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs)
- Responsible for reviewing and tracking of study essential documents (e.g., IRB approvals, 1572s, CVs, investigator licenses and board certifications, lab certifications and normal ranges, etc) to ensure completeness and accuracy
- Verify and ensure proper storage/handling, accountability and distribution of investigational product and trial supplies
- Review and track regulatory documents and the verification of data management queries to meet clinical study timelines
- Monitor clinical studies in accordance with sponsor's protocol and GCPs to assess the safety and efficiency of investigational products
- Applying FDA regulations and ICH-GCP guidelines to all aspects of clinical studies including but not limited to: protocol compliance, IRB submissions, ICF review, handling adverse events to ensure safety and protection of study participants and enhanced data credibility
- Involve in the investigator site identification process and performed site evaluation visits to ascertain site's capabilities and suitability to conduct the clinical trial
- Performing ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication
- Responsible for preparing reports for all site visits conducted, providing input and maintaining investigator and site management information in relevant systems (e.g., CTMS), identifying site needs, providing solutions to facilitate the clinical trial process and assisting in ongoing site personnel training.
ParexelHackensack, NJ
Clinical Trial Assistant
04.2015 - 10.2018
Job overview
- Provided start-up and ongoing trial regulatory document management
- Supported the clinical project team throughout assigned study projects
- Obtained, reviewed, processed, and tracked study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.) Essential Documents – Site Startup: Collected essential regulatory documents from site during site startup
- Review regulatory documents for completeness and accuracy
- Communicated with study teams as needed for completion / revisions to documents
- Compiled / prepared regulatory document checklists, as needed, for site activations/enrollment
- Create/maintain electronic Trial Master File (eTMF) naming conventions by project
- Establish eTMF as assigned by project and perform initial documents upload
- Maintained the electronic Trial Master File (eTMF) as assigned by project
- Upload and maintain eTMF files, folders and documents by project, as assigned
- Collect essential documents from sites to maintain current and accurate documents
- Review regulatory documents as received for completeness and accuracy
- Communicate with study teams and/or monitoring team as needed for collection of regulatory documents
- Ensure complete eTMF at the time of study close
- Prepared, handled and distributed of Clinical Trial supplies and maintenance of tracking information
- Performed reviews of Informed Consents (ICF), subject documentation and other regulated documents for Institutional Review Board (IRB) approval
- Tracked and manage Case Report Forms (CRF), queries and clinical data flow
- Performed administrative tasks to support team members with clinical trial execution as needed
- Setup and manage regulatory document trackers/reports as assigned
- Maintained professional approach respecting the dignity and confidentiality of associates, manager, and vendors.
Galaxy Home HealthNew York
Residential Manager
10.2013 - 03.2015
Job overview
- Managed assigned group homes to ensure quality practices are in place
- Monitored documentation in assigned homes for consistency with the requirements of the Dept
- Of Aging and Disability Services (DADS) including residential notes, program plans, behavioral plans, positioning schedules, supervisory schedule
- Reviewed incident and injury reports for accuracy
- Supervises Home Coordinators in assigned group homes
- Diagnosed problems and initiates corrective action
- Promoted and demonstrated ethical and professional conduct at all times, ensuring employee‘s conduct themselves in an ethical and professional manner
- Promoted continuous quality improvement projects and ongoing performance measures
- Monitored the development and implementation of high quality individual support plans
- Oversaw performance evaluations, corrective actions and other employee related issues
- Suggests methods to improve efficiency
- Remains up-to-date on basic employment laws
- Assisted in assessing the training needs of employees
- Coached and mentored employees for improved performance
- Participated on various quality teams responsible for maintaining total quality and continuous improvement throughout the company
- Provided monthly reporting of issues in assigned group homes
- Performed all other duties as assigned by manager.
- Interviewed and assessed average of 5 incoming residents per week.
- Managed, scheduled and determined workload for 7 member property management team.
- Reduced turnover rates for staff by providing ongoing training, support, and opportunities for professional growth.
Galaxy Home HealthNew York
Caregiver
07.2010 - 10.2013
Job overview
- Attended to the need of clients in the comfort of their home
- Provided personal care, including baths, personal hygiene, changing bed linen, dressing/undressing, toileting activities, and light housekeeping
- Took and recorded oral, rectal, and temperatures, pulse, respiration, and blood pressure when ordered
- Assisted in ambulation and exercise according to the plan of care
- Performed range of motion and other simple procedures as an extensional therapy service as ordered
- Assisted patient in the self-administration of medication
- Met safety needs of patients and using equipment safely and properly (foot stools, side rails, etc.)
- Reported patient’s condition and significant changes to the assigned nurse
- Adhered to the Organization's documentation and care procedures and standards of personal and professional conduct
- Followed all privacy policies of US CareNet, Infection Control protocols, and maintaining the confidentiality of protected healthcare information (PHI).
- Enhanced patient comfort by providing compassionate and attentive care, addressing individual needs and preferences.
Education
Delta State University.
Bachelor of Science from Management Science
08.2007
University Overview
- Society of Clinical Research Associates
- SOCRA Member since 2015
- Delta State University, BSc Degree in Management Sciences (Marketing), August 2007
Skills
- In-depth knowledge of monitoring process and clinical trial procedures/process
- Experience in Clinical trials systems, such as CTMS, eClinical, BioClinical, eDC such as Medidata RAVE, and INFORM
- Critical thinking
- Time Management and organizational skill
- Working knowledge of ICH, HIPAA privacy rule, GCP and FDA regulations,
- Site Audits, Reports on drug safety, IVRS
- Site Management and Site monitoring expertise
- Advanced medical/scientific knowledge and medical terminologies
- Excellent communication and interpersonal skills
- Self motivated with strong leadership, distinctive interpersonal and communication skills
- A team-oriented professional who works well under pressure
- Vendor management experience
- ICH-GCP guidelines
- Problem-Solving
- Organization and Multitasking Abilities
- Fluent in English
Therapeutic Experience
- Oncology
- Neurology
- Cardiovascular
- Infectious disease
- Endocrinology
- Rheumatology
References
References are available upon request.
Timeline
Senior Clinical Research Associate II
PPD (part of Thermo Fisher Scientific)
08.2022 - Current
Senior Clinical Research Associate
Parexel Inc
04.2020 - 07.2022
Clinical Research Associate1
Parexel Inc
11.2018 - 03.2020
Clinical Trial Assistant
Parexel
04.2015 - 10.2018
Residential Manager
Galaxy Home Health
10.2013 - 03.2015
Caregiver
Galaxy Home Health
07.2010 - 10.2013
Delta State University.
Bachelor of Science from Management Science