Mary Long Personal Info

Clinical Research Coordinator/

Regulatory Affairs Coordinator email: adsetx@r.postjobfree.com phone: 337-***-****

Hello, I’m Mary Long, and I am excited to apply to work with your organization! I was a regulatory affairs coordinator for 2 years, then clinical research coordinator for 8 years with Lake Charles Clinical Trials, until 2014 and have recently returned to the industry in December of 2021 as a Coordinator for Centex Lake Charles, and Regulatory Affairs Coordinator for both Centex Lake Charles and Centex Houston.

I have training in medical ethics and human protections, HIPAA compliance, and was certified as a

(CCRC) Certified Clinical Research Coordinator with the Association of Clinical Research Professionals, from 2010 for the duration of my time at my first site. I am familiar with the detailed work involved in protocol implementation including: timely completion of labs, ECGs and other assessments, Investigational Product management, source documentation creation and completion, and adherence to regulatory requirements including: IRB review, Informed Consent, and Investigator oversight; as well as quality control. During my time at the site, I had the privilege to work with multiple pharmaceutical companies in the conduct of over fifty Phase 2, Phase 3, and Phase 4 clinical trials for various indications under the direct supervision of Principal Investigator, Kashinath Yadalam, MD, as well as with multiple Investigators under the Headlands Research team. I have strong communication skills, an empathetic temperament, attention to detail, and organizational focus, which are attributes that are vital to success in this position. I would love the opportunity to continue my work in this interesting and rewarding field. If selected, I will execute this position efficiently and effectively, while ensuring patient protections and safety, as well as proper data collection and retention. Thank you for your consideration, and I hope to speak with you soon.

Work History

11-2021 Clinical Research Coordinator and Regulatory Affairs Coordinator Present Headlands Research- Centex Studies Lake Charles/ Centex Studies Houston

As a Clinical Research Coordinator, I was Responsible for the following job duties: Recruitment:

Networked and facilitated communication with multiple medical professionals, organizations, and businesses as referral sources to aid in study enrollment Created and distributed site-specific advertisements through local newspapers, television, radio outlets and billboards

Pre screened patients for study participation via telephone interviews, as well as in person discussions, and medical chart reviews Tracked response and results of advertising efforts for Needs Assessment Secured sponsor provided advertising materials (ethics committee approved) and budget to create an advertisement plan tailored to the trial

General Duties:

Coordinated protocol activities with various site staff and the Principal Investigator to ensure all procedures were performed per protocol specifications Completed study specific training and attendance virtual Investigator's Meetings when required, to facilitate in depth knowledge of study design and assigned duties prior to study start Created and completed study intake documents based on specified design to ensure that all required data points were captured in a detailed and accurate manner. Documented relevant communications with patients, pharmaceutical representatives, research physicians, study staff, and regulatory authorities to provide in depth detailed descriptions of study conduct

Organized and monitored Investigational Product Storage area (including appropriated temperature was maintained, and additional security measures enforced for scheduled substances) to ensure quality and accountability of medication was maintained

Hosted Site monitoring visits, Regulatory monitoring visits, and site inspection visits Managed Investigational Product distribution, recording and appropriate storage, and destruction based on Physician's direction and manufacturer and sponsor guidance. Drug accountability review and documentation

Created and maintained Blind breaking/ maintenance plans Completed quality control review of source documentation to ensure complete and accurate information Initiated and filed correspondence with sponsor representatives and CRO regarding study conduct Maintained subject source documentation, including detailed accounts of study communication within the eSource (CRIO Study Management System)

Execution of Study Protocol Required Study Visits: Reviewed Inclusion/ Exclusion Criteria for each research participants to confirm they met enrollment criteria and criteria for continued participation

Reviewed Informed Consent for completion (Informed Consent Process completed by Principal Investigator)

Requested, obtained, and completed initial review of medical records for trial participants Scheduled study visits and ensured completion per protocol requirements including assurance of availability of required study staff, and Principal Investigator Completed collection of vital signs and back up ECG as required Processed and shipped required laboratory specimens Prepared source documents and rating scales for study clinicians Reviewed concomitant medications and adverse event recording with subjects and caregivers for Investigator review

Randomized Investigational Product distribution and recording based on Principal Investigator instructions

Completed progress notes documenting site visits, telephone contacts, and other information relevant to subject visits

Completed Quality Control Review for Completed Study Visit Source Documentation Recorded and reported protocol deviations in accordance with site, sponsor and GCP guidelines Completed Case Report Forms (CRFs) for completed visits in accordance with sponsor timelines Regulatory Duties:

While serving as a Regulatory Affairs Coordinator, I was responsible for completion of the following: Prepared site initiation regulatory packets, continuing review submission, and and study close out submissions for multiple sites and studies

Facilitated on site and remote monitoring visits for Sponsor and CRO staff to collect document for CTM and monitor study progress

Developed and maintained positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review Prepared and submitted trial documents for both sites for IRB review and approval (including FDA Form 1572, Financial Disclosure Forms, and Informed Consent Documents). Tracked IRB review of essential documents across multiple studies and sites, and distributed approved materials as required

Managed Regulatory submissions in coordination with site staff for 30+ clinical trials phases 2-4 Completed root cause analysis for ongoing issues to ensure integrity of research Researched and analyzed regulations applicable to job related duties Reported Serious Adverse Events and Protocol Deviations per GCP and IRB guidelines to ensure human protections

Demonstrated skills in areas of communication, performance management, research, and interpretation of regulations, and managing complex projects through matrix relationships Prioritized and organized regulatory tasks and created workable timelines to complete required tasks for multiple sites and studies in a timely manner

Applied a working knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials to daily activities

Maintained electronic Investigator Site Files in an organized manner to allow for transparency of research and

Maintained and updated training records for multiple sites to ensure delegated staff completed all requirements for their designated role.

02-2006- Certified Clinical Research Coordinator

11-2014 Lake Charles Clinical Trials, Lake Charles As a Clinical Research Coordinator, I was Responsible for the following job duties: Recruitment:

Networked and facilitated communication with multiple medical professionals, organizations, and businesses as referral sources to aid in study enrollment Created and presented educational presentations on clinical research participation and processes, to create learning opportunities for potential participants and referral sources Created and distributed site-specific advertisements through local newspapers, television, radio outlets and billboards

Pre screened inpatients for study participation via telephone interviews, as well as in person discussions, and medical chart reviews

Tracked response and results of advertising efforts to Needs Assessment Secured sponsor provided advertising materials (ethics committee approved) and budget to create an advertisement plan tailored to the trial

General Duties:

Coordinated protocol activities with various site staff and the Principal Investigator to ensure all procedures were performed per protocol specifications Completed study specific training and attendance at in person Investigator's Meetings when required, to facilitate in depth knowledge of study design and assigned duties prior to study start Created and completed study intake documents based on specified design to ensure that all required data points were captured in a detailed and accurate manner. Learned multiple data entry systems and completed timely entry of study data into electronic case report forms to aid the sponsor company with expedited data review Quickly obtained information from multiple sources to resolve data queries issued in electronic format to allow timely assessment and processing of trial data by the sponsor companies Documented relevant communications with patients, pharmaceutical representatives, research physicians, study staff, and regulatory authorities to provide in depth detailed descriptions of study conduct Organization and monitoring of Investigational Product Storage area (including appropriated temperature was maintained, and additional security measures enforced for scheduled substances Stocked and maintained crash cart

Created and presented site standard working protocols to study staff, including amendments Updated patient database

Participated in the creation and maintenance of site-specific standard working protocols Assisted in acquiring supplies and admissions requirements for inpatient trials Hosted site monitoring visits, Regulatory monitoring visits, and FDA site inspection visits Randomized IP distribution and recording based on Physician's direction and completed drug accountability review and documentation

Created and maintained Blind breaking/ maintenance plans Completed quality control review of source documentation to ensure complete and accurate information Initiated and filed correspondence with sponsor representatives and CRO regarding study conduct Execution of Study Protocol Required Study Visits: Reviewed Inclusion/ Exclusion Criteria for each research participants to confirm they met enrollment criteria and criteria for continued participation

Reviewed Informed Consent for completion (Informed Consent Process completed by Principal Investigator)

Requested, obtained, and completed initial review of medical records for trial participants Scheduled Study Visits and ensure completion per protocol requirements including assurance of availability of required study staff, and Principal Investigator Completed collection of Vital Signs and back up ECG and laboratory collections as required Processed and shipped required laboratory specimens Prepared Source Documents and Rating Scales for study clinicians Reviewed concomitant medications and adverse event recording with subjects and caregivers for Investigator review

Randomized Investigational Product distribution and recording based on Principal Investigator Instructions

Completed progress notes documenting site visits, telephone contacts, and other information relevant to subject visits

Completed Quality Control Review for Completed Study Visit Source Documentation Recorded and reported protocol deviations in accordance with site, sponsor and GCP guidelines Completed Case Report Forms (CRFs) for completed visits in accordance with sponsor timelines 02-2004- Certified Clinical Research Coordinator

11-2014 Lake Charles Clinical Trials, Lake Charles While serving as a Regulatory Affairs Coordinator, I was responsible for completion of the following: Developed and maintained positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review Prepared and submitted essential trial documents for both Central and Local IRB review and approval

(including FDA Form 1572, Financial Disclosure Forms, Clinical Protocol, and Informed Consent Documents)

Completed of Root Cause Analysis and CAPA plans for ongoing issues to ensure integrity of research Researched and analyzed regulations applicable to job related duties Reported deviations to the IRB per regulatory and GCP requirements and within timelines and scope provided in IRB Guidance.

Demonstrated skills in areas of communication, performance management, research and interpretation of regulations, and managing complex projects through matrix relationships Prioritized and organized regulatory tasks and created workable timelines to complete required tasks in a timely manner

Applied a working knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials to daily activities

Maintained electronic Investigator Site Files in an organized manner to allow for transparency of research

Maintained and updated training records for study staff to ensure delegates met all requirements for their role in the trial.

11-2014- Dual Rate Table Games Supervisor

08-2020 Golden Nugget Casino and Hotel, Lake Charles While employed as a Table Games Dual Rate Supervisor, I completed the following tasks: Provided excellent customer service, while ensuring procedural compliance by table games employees to state regulations, as well as company policies, while supervising various table games Greeted and served guests from multiple cultural backgrounds, and facilitated ongoing relationships to encourage continued patronage

Handled 50 +customer interactions daily, and provided detailed, personalized, friendly & polite service to ensure customer retention

Received high ratings on employee evaluations including customer service, reliability and procedural knowledge

Assisted guests in registering for loyalty programs and in navigating electronic systems, to better encourage enjoyment of player rewards and promotions, and to enhance customer satisfaction with the Golden Nugget brand

Fielded customer complaints, maintaining a calm, collected, friendly, and empathetic demeanor, while actively listening to assist with conflict resolution Remained courteous and calm at all times, even during moments of intense customer displeasure Learned the use of Table View and Oracle systems software to maintain accurate client database records, including both technical and promotional data, to facilitate efficient account management Mastered detailed procedural information on all 10 major table games, and dealt and supervised the conduct of those games in accordance with state and company policies Assisted in on-the-job training for new table games personnel, including assuring adherence to game protection protocols, customer service standards, and accuracy in procedural conduct of gaming activities

Exercised independent decision making skills when correcting dealer mistakes, and ensured clear communication of this process with both clients and staff, to enhance transparency and maintain favorable customer and employee relations

Exercised effective communication when alerting supervisors, surveillance personnel, and security staff of relevant monetary transactions and environmental issues in a timely manner. Tracked and reported large cash transactions in a detailed and timely fashion, per federal requirements and in alignment with company policies.

Provided a pleasant and efficient work environment for myself and my colleagues, by ensuring that work areas were clean, orderly, well stocked, and organized Quickly and accurately performed required calculations, and settled winning and losing wagers according to established rules on all assigned games Constantly monitored and adjusted bankroll information on multiple active table games Monitored and documented inventory checks for required gaming supplies to verify secure disposal of used items and protect game security

Monitored, protected, and maintained accountability for bankroll on multiple live table games valued at over $100,000 per game

11-2020- Licensed Life and Health Insurance Producer present American Income Life Insurance, Baton Rouge (Remote) While working as a Life Insurance Producer I was responsible for the following job duties: Provided coverage option information to assist clients in protecting assets Attended continuing education courses and workshops to gain additional insurance industry knowledge. Customized existing insurance programs to suit individual client needs by analyzing specific requirements.

Sought out new clients and developed client relationships through networking, direct referrals, lead databases and cold calling.

Collected premiums on or before effective date of coverage. Conducted annual reviews of existing policies to update information. Remained impartial in order to advise clients based on circumstances. Displayed consistent, positive attitude towards customers, peers and other personnel, even during high- stress situations.

Worked with sales team to collaboratively reach targets, consistently meeting or exceeding personal quotas.

Met with customers to provide information about available products and policies. Determined financial needs by assessing existing coverage and aligning new products and services with long-term goals.

Handled approximately 800 outbound and inbound sales-related calls per week to qualify individuals interested in purchasing insurance coverage.

Reviewed policy applications for errors and liaised with underwriters to facilitate quick completion of application process.

Analyzed retention, loss ratio trends and sales volume to identify areas for improvement. 08-2020- Medical Customer Service Representative Agent present NexRep/ Care Centrix (Remote)

As a Medical Customer Service Representative, I had the following job duties: Assisted Customers with opening claims for durable medical equipment and supplies, as well as home health services.

Assisted customers with special order requests and arranging medical merchandise delivery and pick-up to facilitate hospital discharge in a timely manner. Contacted insurance carriers to discuss policies and individual patient benefits. Verified client information by analyzing existing evidence on file. Maintained strong knowledge of basic medical terminology to better understand services and procedures.

Maintained customer satisfaction with focus on addressing customer needs and resolving concerns. Coordinated services with vendors and agencies to ensure continuity of care and availability of medical supplies and equipment to clients.

Answered customer telephone calls promptly to avoid on-hold wait times. Consulted with outside parties, including physicians and providers to resolve discrepancies and create effective solutions.

Communicated with vendors regarding backorder availability, future inventory and special orders. Directed incoming calls to internal personnel and departments, routing to best-qualified department. Offered ample support to team members with creative solutions to complex challenges regarding scheduling, conflict resolution and medical care.

Fielded concerns surrounding patients and care, liaising between physician, patient and insurance company.

Maintained organized and secure customer files to facilitate customer support and follow-up and maintain HIPAA Compliance at all times.

Handled high volume of inbound calls per shift to offer callers product and service information and generate quotes.

Followed through on all critical inter-departmental escalations to ensure that quality of care was not affected.

Exhibited high energy and professionalism when dealing with clients and staff. Responded proactively and positively to rapid change. Promoted superior experience by addressing customer concerns, demonstrating empathy and resolving problems swiftly. Education

09-2013 Psychology, Bachelors of Science

Northwestern State University, Natchitoches

11-2010- Certified Clinical Research Coordinator, Certification 11-2014 Association of Clinical Research Professionals, Baton Rouge 11-2014- CITI Training, Good Clinical Practices

University of Miami Provided

Skills

Interpersonal Communication and Team Building

Trial Management

Good Clinical Practices

Organization and Time Management

Proficient in both Microsoft Word Microsoft Excel, CRIO eSource/ eISF and IRB Portal Management

ECG and Phlebotomy

References

Kashinath Yadalam, MD Principal Investigator, Lake Charles Clinical Trials: adsetx@r.postjobfree.com William Houser, Dual Rate Table Games Supervisor, L'Auberge Casino and Resort: 337-***-**** Kelsey Kay, Site Director Centex Studies Lake Charles: 337-***-**** /adsetx@r.postjobfree.com

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