Mental Health Case Manager

FELIX E. ONWUGBUFOR

Email: ******@*****.***

Phone:856-***-****

PROFESSIONAL SUMMARY:

To obtain a position as a Mathematician for CDC Research Organization where I can utilize my medical and clinical research knowledge along with my strong Mechanical Engineering knowledge of computation background to facilitate statistical data’s that are collected from clinical trials and drugs from multiple therapeutic areas. Also to ensure that study conduct at the site is in accordance with the trial protocol, ICH GCPs, SOP and all applicable regulations. I am capable of monitoring multiple therapeutic areas simultaneously. I am a road warrior. Couple of years ago I completed an Online advance Professional Certification course on Public Health (opioid Crisis in America) at Harvard University, Boston, MA. PROFESSIONAL WORK EXPERIENCE:

Spring Community Haman Services, Inc, Pennsauken, NJ Mental Health Professional 10/23/2022 – Present

Counsel adults and teenagers with mental health challenges which ranges from Addiction & Substance abuse, alcohol addicts, behavioral issues ( ADHD, Anxiety, Depression, Bipolar disorders, PTSD; post traumatic stress disorder, OCD, disruptive Behavior and dissocial disorder etc.

I write Treatment Plan and follow-up to monitor the effective of it, since it is on individual case by case bases. Weekly report is written which help to review daily observations and hourly activities of the client under review.

Ortho Clinical Diagnostics, Raritan, NJ

Clinical Research Associate 04/15/2020 – 10/15/2022

• Monitoring CE marked Covid-19 total and lgG antibody test are being supplied to ortho customers all around Europe

• Manages the investigational product, storage, inventory, dispensing records, packaging and labelling, and the trial material (Investigator Study File ISF, CRF, questionnaire, diaries, etc.)

• Track and manage study documents – case report forms (CRF), serious adverse event

(SAE) reported, clinical notes and enrollment logs for accuracy and completeness, as well as discrepancy resolved

• To ensure timely and correct supply to the sites

• Monitor the adverse event (AE) if any about products

• Ensure that correct quantity and products are properly labeled

• Make sure that the product is used according to protocol Accelovance, Rockville, MD, Inc.,

Clinical Research Associate I 01/10/2017-03/17/2020

• Responsible for monitoring all types of clinical trials; ensure Investigators’ adequacy; adherence to Protocols, SOPs GCP, applicable regulatory requirements and compliance with all study procedures

• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions

• Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical trials

• Interfaces with clinical sites/investigators on-site and through off-site administrative site management to ensure compliance with protocols and regulatory compliance Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.

• Review, track, and manage study documents (Case Report Forms (CRFs), Serious Adverse Event (SAE) reports, clinical notes, and enrollment logs) for accuracy and completeness, as well as query resolution.

• Collects and reviews regulatory documents (1572s, Financial Disclosure Forms, CVs, Medical Licenses, etc.) for accuracy and completeness from study start-up through close-out.

• Responsible for one or more protocols with multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study procedures; including investigator selection, reviewing regulatory documents, and preparing reports while meeting timelines/milestones.

• Manages the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc) to ensure timely and correct supply to the site.

• Set up the study sites ensuring each site has the staff training to trial-specific industry standards, the required clinical trial materials, and the study specific regulatory documents.

• Monitor clinical studies to ensure the quality and integrity of data entered in study documents verified against source documentation on-site.

• Ensure that monitoring visits are performed in accordance with protocol/SOP monitoring plan requirements and that these are tracked, including report status and sign off. Northeast Family Practice, Pennsauken, NJ

Clinical Study Coordinator 03/03/2013-12/29/2016

• Reviewed and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.

• Conducted and/or participated in the informed consent process/discussion with research subjects, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places per the research SOP. Assures that amended consent forms are appropriately implemented and signed respectively.

• Screened subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential subject's eligibility accurately.

• Facilitated and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Coordinated patient visits as assigned by research manager.

• Performed venipuncture to collect blood samples per the protocol. Processes blood samples per the protocol and lab manual guidelines for each study.

• Registered each participant in the electronic data capture (EDC) to ensure billing of study procedures to the appropriate funding source.

• Collected data as required by the protocol. Assures timely completion of Case Report Forms, paper or electronic. Must be attentive to data queries and resolve them within the required timeframe.

• Worked with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals.

• As delegated by research manager, collects documents needed to initiate the study for sponsor submission (e.g., FDA Forms 1572, CVs, medical licenses, IRB applications, etc.).

• Documented date of training and signatures of study staff on study specific training log.

• Created source documents for data capture per study protocol and manual of procedures.

• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

• Coordinates monitor site visits and assists with preparation of site visit documentation.

• Maintained CVs and training materials per protocol. Spring Community Human Services, Pennsauken, NJ 08105 Behavior Specialist Consultant 10/15/2003-02/26/2013

• Designed, developed and implemented all programs related to substance use and abuse prevention and intervention in conjunction with the Mental Health Consultant, Counseling and Health Services staff, Center Physician and Center Director.

• Coordinated all programs designed to reduce and eliminate substance use and abuse.

• Worked with Health and Wellness staff and Center Standards Office for the collection of drug test specimens, the documentation of results, and the consultation with students regarding results.

• Provided individual counseling for students regarding substance abuse and prevention, and healthy choices.

• Conducted regular presentations for all students participating in program areas and transitioning out of the Job Corps program on managing substance misuse, abuse, and dependency issues in the workplace.

• Conducted in-service training sessions with both staff and students in all areas related to substance use and abuse.

• Submitted recommendations to the Center Director for medical separations related to substance misuse and abuse in conjunction with the Mental Health Consultant, center physician, and Health and Wellness Manager.

• Acted as liaison between the center and agency resources and referral contacts.

• Completed drug use risk assessments on all new intake students in conjunction with Mental Health Consultant and Counseling.

• Maintained confidential reports and records on all referrals and cases. Maintains all documentation of student results and group and activity participation.

• Completed pre-arrival phone calls to new applicants on an as needed basis.

• Prepared and submitted appropriate reports as required.

• Facilitated Healthy Eating and Active Lifestyle (HEALS) groups in conjunction with Recreation and Health and Wellness Staff.

Northwestern Human Services, Philadelphia, PA

Behavioral Specialist Consultant/ Mobile Therapist 05/20/2000-09/30/2003

• Provided consultation and clinical intervention to the treatment team, family and school.

• Developed treatment plan goals and monitors client's progress towards goals in both the school and home setting, including conducting functional behavioral assessments.

• Developed and implements specific and creative behavior plans and interventions.

• Completed related clinical documentation (i.e. diagnostic tools, progress summary and progress notes.)

• Provided education and works to ensure continuity of care across all settings.

• Provided clinical therapy and direct services to the client and family, including individual and family therapy. Has the ability to utilize creative interventions to motivate the child and the family to make changes as necessary.

• Built rapport with client and assists client in achieving treatment goals via skills building, positive reinforcement, and self-monitoring techniques.

• Completed progress summary and progress notes.

Multitask/COMPUTER SKILLS

• Deep knowledge of monitoring procedures.

• Detailed knowledge of GCP and ICH guidelines including basic understanding o regulatory requirements.

• Basic knowledge of clinical trial process.

• Knowledgeable in CTMS (Clinical Trial Management System), INFORM and eDC (electronic CRF), Medidata RAVE, dfatalabs, IWRS; endpoint, Balance, Clinphone

• Able to work under optimal supervision

• Excellent organization, planning and problem solving abilities.

• Established interpersonal and communication skills.

• Able to work effectively and efficiently in a matrix environment.

• Experience in Microsoft Office, Excel, Power Point, Word, Access, and Visio

• Road Warrior up to 75% travel

EDUCATION

06/02/19-08/07/19: Online 7NBCC,CE Cr. Hrs. Public Health at Harvard Universty, MA 01/2003-05/2003: 7 Graduate Cr. Applied Behavior Analysis(ABA), Temple University,Pa 09/1995-07/1999: Degree in Medicine(MD), St Mary’s School of Medicine, Cook Island, South Pacific

07/1999: Graduation

09/1985-09/1989: BSc., Drexel University, Phila., Pa 03/1990: Graduation

01/1983-09/1984: Assoc. Degree Science, Camden County College, New Jersey 05/1985: Graduation

ACADEMIC HONORS:

Thomas H. Mulhoolland Scholarship. Drexel University -1988-1989 Dean’s List: 1985 Camden County College

Citizenship: USA

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