Clinical Research Manager

Sade Aloba, BSc

Newnan, Georgia

Tel: 219-***-****

Email: adkh6i@r.postjobfree.com

Objectives:

A position in Clinical Research, whereby my clinical experience and background, clinical trials expertise, strong work ethics, and exceptional leadership skills will be best utilized to meet scientific research goals and business objectives. Seeking a position in clinical research to protect the rights, safety and well being of human subjects in clinical trials, ensure trials data are accurate, complete and verifiable using the ALCOA-C principles and to ensure trials are conducted according to ICHGCP Guidelines and regulatory authority requirements.

Skills and Abilities:

Ability to work closely with quality control, research, and the latest Medical Quality System.

Skilled in performing risk assessments, query resolutions, and clinical support to regional teams.

Ability to lead, contribute, and develop web-based trainings.

Capability to use initiative and interact with a client organization professionally.

Ability to undertake leadership qualities and work within a team.

Detail oriented, strong interpersonal skills, excellent skill set with computers, and utilizing various study systems.

Strong history of outstanding performance.

Demonstrate outstanding people management, time management, project management, organizational, and communication skills.

Expertise and excellent skills working with core systems and tools.

Ability to prioritize and meet assigned tasks and project goals and deadline,s

Strong knowledge of FDA and ICH-GCP guidelines regarding research and development .

Summary of Qualification:

3+ years of experience in Clinical Research and deep knowledge of the pro procedures – field based (phases I – IV).

Detailed knowledge of GCP and ICH guidelines and understanding of state and federal regulatory requirements.

Comprehensive knowledge of applicable sponsor SOPs for site monitoring.

Extensive knowledge of clinical trial process.

Proficient in Electronic Data Capture and Interactive Voice Response System

Workload consists of 5 protocols.

Presented ICH GCP training to site staff

Therapeutic Experience:

Endocrinology – Diabetes Type II

Cardiovascular – Stroke, Heart Failure

Infectious Diseases-HIV, Hepatitis B

Bunionectomy-Pain Management

Professional Work Experience

Clinical Research Associate I

MedSource CRO Houston, TX [Feb 2018 - Present]

·Perform clinical monitoring activities to ensure the quality and integrity of data, compliance with SOPs, ICH, GCP, and regulatory requirements ensuring study completion on time and within budget.

·Sustain contact with sites, perform site visits from selection to close-out, assess and confirm patient safety, data quality, and adherence to the protocol and relevant SOPs.

·Conduct protocol training to staff at investigator site during site initiation visit to ensure that site is equipped to conduct the clinical study.

·Monitor the conduct of the study at assigned clinical study sites and review source documents, CRFs, regulatory documents, informed consents, investigational product, clinical supply accountability and AE/SAE reporting.

·Perform drug accountability and revised drug accountability records to confirm consistency with the physical inventory of the study medication.

·Ensure that serious adverse events (SAEs) are reported to the sponsor and IRB in a timely fashion and appropriately documented in the patient’s source documents and CRFs.

·Provide guidelines to the investigational site staff on their roles and responsibilities in conducting clinical studies, evaluate site performance, and provide re-training when required.

· Document and track resolution of all outstanding site-specific protocol-related issues at every visit.

·Attend clinical monitoring staff meetings and project team meetings as planned.

·Assist in the preparation of study start-up documents including 1572s, CVs, investigator study files, enrollment logs, etc.

·Communicate with clinical team members and participate in team meetings and updates.

·Develop and maintain good relationships with investigators and site workers.

·Review trip reports and track scheduling, report submission metrics, site deviations and action items.

·Manage site and monitoring issue prevention, escalation and corrective actions.

·Develop, execute, manage and ensure compliance of the Monitoring Plans.

·Perform pre-study visits to help identify adequate study sites that have the resources and facilities to conduct the clinical study.

·Conduct protocol training to staff at investigator site during site initiation visit to ensure that site is equipped to conduct the clinical study.

·Monitor the conduct of the study at assigned clinical study sites and review source documents, CRFs, regulatory documents, informed consents, investigational product, clinical supply accountability and AE/SAE reporting.

·Perform drug accountability and review drug accountability records to ensure consistency with the physical inventory of the study medication.

·Independently schedule and perform selection, initiation, interim, and close out monitoring visits and prepare required documentation.

·Provide instructions to the investigational site staff on their roles and responsibilities in conducting clinical studies, evaluate site performance, and provide re-training as necessary.

·Collect and review regulatory documents.

·Assist in ensuring that all site data queries are addressed in a timely fashion.

·Schedule and prioritize workloads to meet projected deadlines.

·Close the investigational site at the end of the study ensuring that all study supplies are returned to the sponsor as required or destroyed by the site.

Project Specialist/Clinical Trial Assistant

MedSource CRO Houston, TX [Feb 2015 – Feb 2018]

Provided general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).

Assisted the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.

Set up, organized and maintained clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.

Co-ordinated ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.

Assisted in co-ordination of Investigator payments.

Assisted project teams with trial progress tracking by updating the Clinical Trial Management systems.

Contacted clinical sites for specific requests for enrollment updates, missing documentation, meeting arrangements and so on.

Assisted in the tracking and distribution of safety reports.

Supported the Clinical Operations teams with ongoing conduct of studies.

Assisted project teams with study specific documentation and guidelines as appropriate.

Assisted with routine data analysis and interpretation using data analysis programs.

Assisted in the setup, operation, and maintenance of research equipment/instruments

Developed all sites as per regulatory binders and maintained associate shadow binders.

Provided assistance to clinic staff by organizing files, projects, data, etc.

Provided general office management to keep operations running smoothly.

Assisted with the development and execution of clinical research studies and programs.

Assisted the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.

Worked under specific instructions to assist with routine tests, experiments, and procedures.

Entered data from forms and documents into databases and other documents.

Assisted with routine data verification and quality control, ensuring data integrity and consistency with prescribed protocol.

Managed and organized all shipments and supplies for clinical research sites.

Collaborated with various teams to administer logistics and drug shipments and ensure optimal safety and maintain track of all management files and tools and participate in various meetings with clients and investigators.

Worked with various study staff on site and gather all required documents.

Collaborated with site staff to monitor all data and make required travel arrangement

Maintained records and logs of all clinical research programs and assisted in filing and preparing presentations in both media and graphic format.

Trial Master Specialist

MedSource CRO Houston, TX [Jan 2012 – Feb 2015]

Assisted with establishing and maintaining TMF monitoring and reporting.

Delivered reports to study team, managed expectations, and tracked ongoing KPI across study team in conjunction with the Clinical Trial Managers and Clinical Project Leads.

Provided best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives.

Supported integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.

Assisted with CRO eTMF configuration testing as needed.

Assisted with TMF process education efforts.

Provided process and planning support to the Clinical Trial Managers and Project Leads for TMF related remediation and process execution as needed.

Proactively stayed current with best practices and recommended application across portfolio to continuously improve TMF operations processes.

Led projects in support of study or portfolio TMF objectives and attended standing cross functional meetings

Academic Background

University of East London

Bachelors of Science in Sociology

Certifications

ICHGCP Certified

Transportation of Dangerous Goods (IATA Certificate)

Mayo Clinic Laboratories

Human Subject Assurance Training (Module I-III)

Office of Health and Research Protection (OHRP)

NIH – Protecting Human Research Participants Certificate

National Institute of Health Office of Extramural Research

NIH – Clinical Research Training Course Certificate

National Institute of Health Office of Clinical Research Training & Medical Education

Computer and Software Application

EDC: Medidata RAVE, InForm, OC RDC

CTMS: eClinical, Homegrown CTMS, Rave CTMS, Impact

IVRS: IMPALA, IRT, Trident

TMF: Electronic Trial Master File, Veeva Vault, Trial Interactive

Contact this candidate