Aramide Balogun
Houston,TX
Summary
To obtain a Clinical Research position that utilizes my knowledge and experience and enables me to grow in my career with while impacting lives for a positive cause. Passionate about making a difference through medical advancement/
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Stanley H. Appel Department of Neurology
10.2022 - Current
- Serve as a clinical research coordinator for the HMNI Neuromuscular Research Department, responsible for managing complex research projects that may involve single or multiple sites and/or research teams conducting research activities
- I work directly with multiple PIs and I’m responsible for day-to-day research activities as well as planning the PI’s research agenda/ program
- I also work with research participants within the parameters of the IRB approved protocol and clinical care, review and manage essential regulatory documentation, interface with sponsors, CROs, IRBs & external auditors per applicable federal and local regulations, ICH-GCP E6(R2), and institutional policies and procedures
- I monitor progress and performance of all projects to include quality of services, research data quality assurance and data quality control, timelines, financial viability, compliance with federal, state and/or other regulations, laws and guidelines of Houston Methodist Research Institute (HMRI)
- In addition, I provide guidance to staff, adhering to budget compliance, contributing to new staff such as coaching and counseling employees on work related performance, and assisting in the development and implementation of policies and procedures to ensure a safe and effective work environment
- I perform duties to support Phase I-IV drug trials, registries with biomarker collection, observational, and devices studies in a dedicated neuromuscular clinical research department
- Communicate directly with sponsors, CROs, IRBs, and trial participants and their families to conduct trial activities by monitoring participants safety, physician and investigator communications, and trial integrity
- Collect data guided by FDA ICH-GCP as stipulated by federal and local regulations, institutional policies and SOPs
- Conduct all aspects of recruitment, consent, and retention of study subjects
- Responsible for obtaining consents, reviewing trial eligibility, management of investigational products, laboratory processing and collection of vital signs, ECGs, spirometry, and phlebotomy
- Oversee all components of a study required for successful completion of enrollment, retention, and close-outs of clinical studies.
Clinical Research Specialist
Stanley H. Appel Department of Neurology
10.2021 - 10.2022
- Serve as a clinical research specialist for the HMNI Neuromuscular Research Department, supporting the interprofessional team of investigators, nurses, and clinicians and performing clinical research support functions assigned by the clinical trial manager
- Complete required case report forms and resolve queries
- Ensure accurate data collection, documentation organization, regulatory filing, and safety of study volunteers
- Assure study conduct meets appropriate and applicable regulations, i.e., IRB, FDA, HIPAA, IND; institutional policies, ICH GCP guidelines, and sponsor requirements
- Responsible for obtaining consent, laboratory processing, collection of vital signs, phlebotomy, data entry in electronic databases as required per study, spirometry, and ECG collection
- Communicating with study monitor, responsible for IRB submissions and trial related communication and reporting
- Transport blood and tissue samples per OSHA requirements, process, and package lab samples for shipping to sponsor or storage at site per the study manual of operations and IATA requirements
- Assist clinical trial manager in identifying opportunities to improve research workflow by providing recommendations and contributing to meeting department and hospital targets for quality and safety.
Customer Service Associate
Conduent, Inc.
12.2019 - 04.2021
- Responsible for compiling reports on overall customer satisfaction by collecting and analyzing customers’ information and by guiding and suggesting additional options of interest
- Worked independently and with a team to meet sales goals and call quotas
- Handled complaints by collecting specific information for action, including providing appropriate solutions by following communication procedures, guidelines, and polices
- Assisted customers with product orders, returns, cancellations, taking payments and similar pertinent customer support information
- Performed team meetings to train employees and motivate employees to meet sales goals based on reports.
Customer Service Associate
Amazon, Inc.
06.2015 - 08.2018
- Provided outstanding customer service to inbound callers by connecting with customers while responding to inquiries
- Performed upselling by introducing products offered based on customer’s preferences or needs, as well as data entry and customer assistance
- Demonstrated the ability to multitask and handle confidential financial and personal information.
Administrative Assistant
Rhode Island College
08.2013 - 05.2015
- Performed filing, data management, drafting and editing office memos, and similar administrative support tasks
- Responsible for answering phone enquiries, attending to visitors, and assisting staff to meet department goals
- Responsibilities included email reminders, maintaining, and updating member rosters, scheduling appointments, and records of financial duties.
Education
Clinical Research Student Program -
Clinical Research Fastrack
Scottsdale, AZ10.2021
Bachelor of Science in Marketing -
Rhode Island College
Providence, RI01.2014
Skills
- Good Clinical Practices
- Electronic Data Capture
- Documentation Management
- Adverse event reporting
- Patient recruitment
- Phlebotomy
- Completing regulatory documents
- Clinical Data Management
- Clinical Documentation
- IRB Submissions
- Research experience
Skills Competencies
multiple Microsoft programs, electronic data systems, and data entry, etc., medical history collection, subject/participant interviewing, vital signs, ECG, phlebotomy, spirometry, specimen processing, IATA Shipping, subject testing, etc., Redcap and Medidata, Epic, answering feasibility questionnaires, submitting regulatory documents, IRB submissions and modifications, budget negotiations, CTA submission
Certification
- 2021, Good Clinical Practice Certificate, Clinical Research Fastrack, Scottsdale, AZ
- 2022, Cardiopulmonary resuscitation basic life support/Healthcare Provider CPR with AED, American heart association
- 2022, Houston Methodist Phlebotomy Skill Training for Research Coordinator Certificate, Houston Methodist
Clinical Research Experience
- A Study of Biological Markers for the Nervous and Immune Systems and Free Radical-Mediated Processes in Amyotrophic Lateral Sclerosis
- Compilations of Clinical Findings in Amyotrophic Lateral Sclerosis- Verity Database
- Myotonic Dystrophy Compilation of Clinical Findings
- Phase I Study in ALS with Abatacept & IL-2
- Long-Term, Observational, Registry of Patients with Generalized Myasthenia Gravis Who Have Received Treatment with Complement C5 Inhibition Therapies
- Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophic Type 1 (END-DM1)
- Myasthenia gravis and COVID-19: Case Series on Hospital Course and Outcomes
- Observational Study of COVID-19 Positive Patients of Neurological Manifestations and Their Outcomes
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
- An observational Study of Adult Patients with Spinal Muscular Atrophy Receiving Spinraza (nusinersen) or Evrysdi (Risdiplam)
- A study to perform Apheresis (Leukapheresis) on Patients with Amyotrophic Lateral Sclerosis to Collect Regulatory T-Lymphocytes (Tregs)
- A Prospective, multi-center, Observational study of the safety, tolerability, and effectiveness of Spinraza in adult patients with Spinal Muscular Atrophy
- A Phase 3, open-label extension (OLE) study to evaluate 6-week treatment cycles of rozanolixizumab in study participants with GMG
- HEALEY ALS Platform Trial
- Protective Genetic Factors against Neurological Disease
- Observational Study of Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Their Outcomes
- A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic
- Autologous T-cells Expressing A Chimeric Antigen Receptor Directed to B-cell Maturation Antigen (BCMA) in Patients with Generalized Myasthenia Gravis (MG)
- A Global Observational Multicenter Long-Term Study of Patients with Transthyretin (TTR)-Mediated Amyloidosis (ATTR amyloidosis)
- A randomized placebo-controlled Phase 3 clinical trial to test the efficacy and safety of ALXN1720 in adult patients with generalized myasthenia gravis (gMG)
- A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating
- Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Timeline
Clinical Research Coordinator
Stanley H. Appel Department of Neurology
10.2022 - Current
Clinical Research Specialist
Stanley H. Appel Department of Neurology
10.2021 - 10.2022
Customer Service Associate
Conduent, Inc.
12.2019 - 04.2021
Customer Service Associate
Amazon, Inc.
06.2015 - 08.2018
Administrative Assistant
Rhode Island College
08.2013 - 05.2015
Clinical Research Student Program -
Clinical Research Fastrack
Bachelor of Science in Marketing -
Rhode Island College