Mental Health Clinical Research
Resume:
Curriculum Vitae
Lucien DM LaRoche, MEd
*** ****** *** ******, ***. 250
Altamonte Springs, FL 32701
*************@*******.***
Education
PsyD Psychology 2019California Southern University, Irvine, CA 2019 Completion
Psychology Northcentral University, Prescott, AZ Doctoral Courses
MEd Counseling University of New Hampshire, Durham, NH 1993
BPS Behavioral Science Granite State College, Durham, NH 1990
AAGS General Studies Granite State College, Durham, NH 1988
Professional Experience
5/2015-Present
Orlando VA Medical Center
South Florida VA Foundation for Research and Education Research Coordinator
Coordinated compliance and monitoring efforts related to human research participant protection. Collected documents required to initiate studies and coordinated submission to the IRB, (e.g., FDA Forms 1572, CVs, etc.). Screened subjects for eligibility using protocol specific inclusion and exclusion criteria, conducted informed consent process with research participants, and coordinated participant tests and procedures. Collected data as required by the protocol, assured timely completion of study timelines.
6/2011-Present
University Behavioral Center Currently Per Diem Admissions Specialist
Responded to telephone and face-to-face inquiries from persons seeking mental health care or information about mental health-related services. Conducted clinical assessments for patient admission to acute, residential, and partial hospitalization programs from ages 3 to 80. Performed pre-certification presentation, handled inquiry calls involving hospital program information to agencies, facilities, and professionals.
7/2013-1/2014
Community Counseling Center of Central Florida Therapist
Provision of individual and family therapy with a focus on Cognitive-Behavioral, Existential and Rogerian methods. Clinical assessment and recommendations for treatment and services for clients involved with the Florida Department of Children and Families as well as correctional/diversionary services. Services provided to children, adolescent and adult populations from the ages of 5 to 50.
3/2012-6/2013
Florida Hospital DeLand ED Care Manager
Biopsychosocial assessment for patients admitted with mental health, behavioral, and addiction presentations. Worked in conjunction with area law enforcement to process Baker Act patients and placements off site. Obtained pre-certification, and provided referral resources for outpatient psychiatry and counseling services.
9/2007-4/2012
Florida Department of Corrections Mental Health Specialist
Varied case assignment to inpatient units at the Correctional Mental Health Institution including Crisis Stabilization Unit, Transitional Care Unit, and extended court committed. Provided individual counseling, development of treatment plans, and recommendations for ongoing services or discharge. Provided crisis intervention services for inmates, consulted with psychiatry regarding recommendations for stabilization.
Professional Experience (continued)
10/2005-4/2008
Florida Hospital Center for Behavioral Health Assessment Clinician
Emergency psychiatric assessments for adult clients seeking voluntary inpatient admission. Evaluated a full range of diagnostic issues ranging from chronic mental illness, situational responses to distress, and addictive behaviors. Processed insurance pre-certification authorizations, and referrals for counseling services/medication clinic.
2/2004-5/2005
Core Research, Inc. Clinical Research Coordinator
Clinical trial preparation involving the planning, development and evaluation of patient information and informed consent forms and patient recruitment. Data collection and management, collection of source documents, using and developing CRFs, registration and management AE’s, filing and archiving, managing monitoring visits. Recruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues.
5/2001-3/2006
Lakeside Behavioral Healthcare Assessment Specialist II and Unit Therapist
Provided clinical services including psychosocial assessments, determination of need for outpatient services, and appropriateness for inpatient referrals. Processed Baker Act commitments, assisted in discharge planning where appropriate, crisis intervention and liaison services with departments within the hospital. Responded to unit-wide codes requesting assistance with seclusion and restraint.
10/1999-5/2002
Intervention Services, Inc. Outpatient Therapist
Conducted psychosocial assessments, identified diagnoses, and individual treatment goals for Intensive On-Site therapeutic services (ITOS), of individual, group, family counseling. Completed required treatment plan reviews, Children’s Functional Assessment Ratings, and Population Identification Certification for children aged 3 to 17. Provided services on-site at public schools and residences.
12/1997-10/1999
Florida Department of Children and Families Protective Investigator
Interviewed clients, reviewed records, and advised removal of child from the home environment when necessary. Utilized Family Systems approach and non-confrontational interaction with families to resolve issues child custody. Worked in an adjunct capacity with law enforcement, State Attorney’s Office, and Inspector General.
5/1997-12/1997
BayRidge Hospital Mental Health Counselor
Provided 1:1 intervention/supervision for patients during 24 to 72 hour inpatient hospitalizations on a locked psychiatric unit. Conducted psychosocial and medical history assessments. Responsible for discharge planning and follow-up with outside providers.
11/1993-12/1997
North Shore Emergency Services Crisis Intervention Specialist
Assisted long-term mentally ill clients connected via the Massachusetts Department of Mental Health with emotional support and stabilization in the community. Established relationships with clients by routine home visits, social activities. Provided social diversions for clients that emphasized social skill building, and interpersonal relations.
7/1993-5/1997
North Shore Emergency Services Emergency Services Clinician
Assessed populations presenting for inpatient psychiatric care and detoxification services. Arranged for hospital admission when clinically necessary and provided referrals for community based treatment options. Contacted insurance providers to secure pre-certification for designated services.
Graduate Internships
9/1992-5/1993
Strafford Psychotherapy and Counseling
Individual and group psychotherapy provided. Individual psychotherapy to predominately-female clientele. Assisted as co-leader for therapeutic groups dealing with abusive relationships and addictive behaviors.
1/1992-5/1992
Sexual Assault Support Services
Provided individual psychotherapy to child and adult victims of sexual assault and abuse.
Volunteer and Community Service
3/1986-6/1991
Sexual Assault Support Services Sexual Assault/Abuse Advocate
Assisted with training to the community and law enforcement agencies on the topics of sexual abuse, domestic violence, and the emotional after-effects of trauma. Provided on-call services to the community via telephone and in person support. Provided support for victims of trauma after an assault via explanation of physical examination and legal process.
Current Professional Memberships
Society of Clinical Research Associates, Inc. Member 2015-Present
American Psychological Association Associate Membership 2013-Present
Certification/Licensure
Registered Mental Health Counselor Intern 2013-Present #11407
Victim Services Practitioner Designee 2010
Florida Certified Functional Assessment Rater 2005 #805-002-622
Florida Certified Children’s Functional Rater 2005 #802-009-704
Massachusetts Licensed Mental Health Counselor 1997-2001 #3873
Clinical Research Experience
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (pyridoxamine dihydrochloride) in Subjects with Nephropathy Due to Type 2 Diabetes. NephroGenex, Inc., Medpace, PRY-311.
A Phase IIb, Prospective, single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis. MiMedx, Protocol 14-00026.
Anal Cancer Screening: A Pilot Study at the Orlando VA Medical Center (HIV, HPV, and Transplant Recipients). Orlando VA Medical Center, Protocol 15-00040.
A Pilot Study on Treatments of Anal Intraepithelial Neoplasia (AIN) at the Orlando VA Medical Center (HIV, HPV, and Transplant Recipients). Orlando VA Medical Center, Protocol 15-00041.
A Confirmatory Multi-Center, Double Blind, Randomized, Placebo-Controlled Study of the Use of Quetiapine Fumarate (Seroquel) in the Treatment of Patients with Bipolar Depression. AstraZeneca, Protocol D1447C00135.
A Multi-Center, Open Label Acceptability Study of Aripiprazole Oral Solution in the Treatment of Outpatients with Chronic Schizophrenia. Bristol-Myers Squibb, Protocol CN138-091-022.
A Multi-Center Randomized, Double Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients with Bipolar I Disorder with a Major Depressive Episode. Bristol-Myers Squibb, Protocol CN138-096.
Clinical Research Study Coordination Experience (continued)
A Double Blind, Flexible Dose Comparison of the Safety and Efficacy of Escitalopram and Placebo in the Treatment of Geriatric Depression. Forest Laboratories, Protocol SCT-MD-13.
A Randomized, Double Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed with Major Depressive Disorder. Glaxo Smith Kline, Protocol BRL-29060/874.
A Phase III, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. Concerta in Pediatric Patients Aged 6-12 with Attention-Deficit/Hyperactivity Disorder (ADHD). Noven Pharmaceuticals, Inc and Shire Pharmaceutical Development, Inc., Protocol SPD485-302.
A Phase III, Multi-Center, Open-Label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 with Attention-Deficit/Hyperactivity Disorder (ADHD). Noven Pharmaceuticals, Inc. and Shire Pharmaceutical Development, Inc., SPD485-303.
A Phase III, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD 503 in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD). Shire Pharmaceutical Development, Inc., Protocol SPD503-304.
A Phase III, Open-Label Study of SPD 503 in Children and Adolescents Aged 6-17 with Attention-Deficit Hyperactivity Disorder (ADHD). Shire Pharmaceutical Development, Inc., Protocol SPD503-305.
A Randomized, Double-Blind Study of the Safety and Efficacy of Depakote ER plus an Atypical Antipsychotic vs. and Atypical Antipsychotic Alone in the Treatment of Schizophrenia. Somerset Pharmaceuticals, Inc., Protocol M02-547.
A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long Term Administration of TAK-375 in Subjects with Chronic Insomnia. Takeda Pharmaceuticals North America, Protocol 01-02-TL-375-022.
A Multi-Center, Randomized, Double Blind, Placebo-Dose Study of DVS-233 SR and Venlafaxine ER in Adult Outpatients with Major Depressive Disorder. Wyeth Research, Protocol 3151A1-317-US.
A Multi-Center, Open-Label Study of DVS-233 SR in Adult Outpatients with Major Depressive Disorder. Wyeth Research, Protocol 3151A1-303-WW.
A Multicenter Randomized, Double Blind, Placebo-Controlled Study of Two Fixed Oral Doses of Aripiprazole (10mg 0r 30mg) in the Treatment of Adolescent Patients with Schizophrenia. Otsuka Maryland Research Institute, Protocol 31-03-239.
A Multicenter, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2mg-30mg) in the Treatment of Adolescent Patients with Schizophrenia and Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features. Otsuka Maryland Research Institute, Protocol 31-03-241.
A 10 week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GABITRIL® at 4, 8, and 12mg/day in the Treatment of Adults with Generalized Anxiety Disorder. Cephalon, Inc., Protocol C6671/3030/AX/US.
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL® Treatment (up to 16mg/day) in Adults with Generalized Anxiety Disorder. Cephalon, Inc., Protocol C6671/3033/AX/US.
Clinical Research Study Coordination Experience (continued)
A Multicenter, Randomized, Double Blind, Parallel-Group, Placebo-Controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache. Solvay Pharmaceuticals, Protocol S175.2.103.
A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects with Psychosis and Behavioral Disturbances Associated with Dementia of the Alzheimer’s Type. Solvay Pharmaceuticals, Protocol S154.3.106.
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults with Mild to Moderate Alzheimer’s Disease. Dainippon Sumitomo Pharma Co., Ltd., Protocol AC-3933-271.
An International, Multicenter Large Simple Trial (LST) to Compare the Cardiovascular Safety of Ziprasidone and Olanzapine. Pfizer, Inc., Protocol A1281062.
Four Week, Double-Blind, Placebo-Controlled Phase III Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I Disorder (Manic or Mixed) Protocol A1281132 with continuation into Open-Label. Pfizer, Inc., Protocol A1281133.
Related Training Courses (2005-2015)
CITI Program: Human Research, Human Subjects Protection HIPAA
Understanding AE’s and SAE’s Instruction on Child Restraints
Ethical Issues in Clinical Research CPR
Health Insurance and Portability Accountability Act CPI: Seclusion and Restraint
Training and Education on the Use of ECG Machines Baker Act Training-University of South Florida
Phlebotomy, Processing of Lab Samples Patient Grievance/Youth Rights
Understanding the FDA Comprehending Informed Consent
Understanding the Process of the IRB Clinical Risk Assessment
Introduction to Good Clinical Practices Acute Care Training
Introduction on the Process of Drug Development Ethical Issues in Counseling
Infection Control Therapeutic Boundaries
Intentional Destruction of Personal Health Information ADHD and Education
Verbal De-escalation of the Mental Health Client Survivors of Abuse
Schizophrenia and New Pharmacological Treatment Increasing Treatment Compliance
References
Available on Request
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