Clinical Research Manager

Clinical Research Associate

JIM NJOTSA, ***** Braesridge Drive, #1027 Houston, TX 77071 *********@*****.*** 713-***-****

QUALITIES

Adaptable with a ‘Can-do' attitude, Energy and Enthusiasm; Communicative Innovative Pro-active Sense of humor. Keeping Track of Responses and Short listing Profiles, with over three year’s clinical monitoring experience. Plan requirements for clinical trial materials, set up and monitor systems and maintain procedures to account for trial materials. Conducts co-monitoring visits and reviewed monitoring trip reports.

KEY INITIATIVES

Coordinate the movement of laboratory samples and ensure that procedures are set for optimization of patients into clinical trials. Provides support to the Oncology Clinical Research study team and maintains key information in various systems in accordance with Good Clinical Practice (GCP), ICH guidelines, Federal Regulations and BMI/Digestive Health Care Center SOPs. Responsible for local ethics and regulatory submissions activities including consulting, performing submissions, feasibility, translation, local adaptation of documents for the assigned countries. Abstracts data from necessary sources to complete the eDC and resolve queries. Serves as the primary clinical liaison between drug development teams and other departments.

CLINICAL RESEARCH SKILLS

– Trial Methodologies – Trail Study Center Setup – Data Collection, GCP-ICH

– Protocols & Drug Development – Investigator Identification – Pre-trial Procedures

– HIPPA Guidelines – Research and Development – Interactive Management

– Integrated Medical Reports – NDAs, FDA Reg./IRB Submissions – Protocol Adherence

SUMMARY OF QUALIFICATIONS

• • Responsible for performing on-site visits (including PSSV, SIV, IMV, COV) and remote site management activities for assigned investigative sites. Prepare trial related documentation including protocols, case report forms and consent documents. Very familiar with oncology and gastrointestinal disease including liver, gallbladder and all endoscopic procedures, the practice is up to date with disease treatment and diagnosis by attending CME courses and conferences. Clinical Study Associate with over three years’ experience supporting CTM teams, Late-Phase Clinical Trials (Anti Invectives, Transplant, Oncology areas.) Ambition to gain international industry experience. Driven and committed, enjoys working as part of a team to achieve shared goals. My Selected Skills are: Trial Master File Quality Control, Effective Communication, Creative Thinking, Ethics & Competent Authority Submissions, GCP & Clinical Trials Administration, Multi Task Management, Process Improvement, Attention to Detail, with Basic Project Management. Responsible for participating in investigator meetings and presenting as required. Enjoys working both independently and as a team member in any environment.

• • Responsible for managing clinical and regulatory aspects of assigned sites to ensure compliance with protocol specifications, SOPs, applicable regulations and guidelines. Pro-actively supports a team of other Study Managers to achieve study milestones on time and within budget. Manages the ‘set up’ (including costing/contract negotiations, ethics submissions and initiation) of 4 sites (2 studies) in line with company procedures, objectives and timescales. Responsible for monitoring an Oncology and an Anti-Infective Study in accordance with company SOPs and MHRA regulations. Designed and implemented SharePoint sites to improve communication between affiliates and promote effective sharing of information and documentation. Implements new process for coordinating the archiving of Trial Master Files from across our affiliates. Builds relationships with Investigator and Site staff to ensure complete and efficient exchange of information and rapid retrieval of all clinical data, especially with results to reporting of (serious) adverse events. Responsible for providing timely and accurate visit reports.

• • Responsible for assisting in the writing or the review of project plans and templates, as required. Coordinate the set-up, maintenance and archiving of Trial Master Files across affiliates, proactively sought to improve quality e.g. liaise with CRO responsible for preparing files for archive and requested feedback on common errors, provided retraining and address common issues found. Assists in the audit of TMFs outsourced to a CRO as well as the company’s archiving storage provider. Ensures high quality clinical data through detail monitoring of data including source data verification (competent in the use of eCRF systems). Pro-actively supports the sites in meeting their recruitment commitments, e.g. identifies trends for ineligibility from pre screening logs, discusses possible solutions with site and feeds back to sponsor study management, which resulted in amended Inform Consent Form. Monitors drug accountability at site and accounts for all medication (used / unused) and ultimate destruction. Responsible for filing and maintenance of Site Files for assigned sites. Tracks payments versus schedule of payments and work done by sites. Responsible for ensuring the integrity of the data collected when Source Data Verification is performed. Well verse with a strong organizational, time management, interpersonal, listening, conflict management and negotiation skills.

•

• Therapeutic Experience: Gastroenterology, (i.e.) Chronic Hepatitis C (Lawitz), Irritable Bowel Syndrome with Diarrhea IBS-d), Gastro-esophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Short Bowel Syndrome (SBS), Eosinophilic Esophagitis (EOE), Dermatology, eDevice, Antiviral, Inflammation, Autoimmune Disorders, Therapeutic Phlebotomy, Hypertension, Oncology, Pain, Neurology/CNS, Respiratory, Cardiovascular, Infectious Disease, Immunology, Metabolism, Diabetes, Pediatrics, Hematology, Vaccines, Transplant and Ophthalmology.

RESEARCH EXPERIENCE:

UCB BIOPHARMA SPRL, Inc. Protocol # RA0098, 2014-Present, A Phase 3 Multicenter, Open-Label Study To Elevate The Safe And Effective Use of An Electro-Mechanical Injection Device (E-Device) For The Subcutaneous Self-Injection Of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, Or Moderately To Severe Active Crohn’s Disease.

SANOFI-SYNTHELADO RECHERCHE, Inc. Protocol # CPR-EFC5826-EN-E01, 2014-Present, A Phase 3 and late Phase 4, Randomized, multinational, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20 mg OD for reducing the risk of major Cardiovascular events in abdominally obese patients with clustering risk factors, on patients with (IBS, IBD, GERD and EoE).

DAIICHI SANKYO PHARMA DEVELOPMENT, Inc. Protocol # ARQ 197-A-U252, 2014-Present, A Randomized, Placebo-Controlled, Phase Study of ARQ 197 in Combination with Irinotecan and Centuximab in Subjects with Metastatic Colorectal Cancer with Wild-Type KRAS Who Have Received Front-Line Systematic Therapy (ARQ 197-A-U252).

ELI LILLY & COMPANY, Inc. Protocol # S124(b) (PARAMOUNT), 2014-Present, A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Nonsquamous Non-Small Cell Lung Cancer.

MERK SHARPE & DOHME CORP., Inc. Protocol # MK-3475, 2014-Present, A Phase 4, Randomized Clinical Trial, A Study of Pembolizumab (MK-3745) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic or Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045).

ABBVIE Inc. Protocol # M13-740, 2014-Present; A Multicenter. Randomized. Double-Blind. Placebo-Controlled Study ABT-494 for the Introduction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn’s Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.

MERK SHARPE & DOHME CORP. Inc. Protocol # MK-3475-057, 2014-Present, A Phase 2, Randomized Clinical Trial, To Study The Efficacy And Safety of Pembolizumab in Subjects With High Risk of Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy.

UCB BIOSCIENCES, Inc. SECURE REGISTRY Protocol # C87075, 2016-Present; A Non-Interventional Long-Term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn’s Disease (CD).

MERK SHARPE & DOHME CORP., Inc. Protocol # MK-3475-119, 2014-Present, A Randomized Open-Label, A Phase 3, Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician’s Choice for Metastatic Triple Negative Breast Cancer (mTNMB) - (Keynote-119).

FERRING Inter PharmaScience Center U.S., Inc. Protocol # 000174, 2014-Present; A Phase III/IV Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended-Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis.

PFIZER / ICON CORP. Inc. Protocol # A3921095, 2013-2015; A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, parallel group study of Cp-690,550 for the induction of clinical remission in subjects with moderate to severe Ulcerative Colitis.

FERRING Inter PharmaScience Center U.S., Inc. Protocol # 000175, 2014-Present; A Phase III/IV Randomized, Double-Blind, Placebo-Controlled, Multicenter, and Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended-Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis.

SHIRE ViroPharma, Incorporated (Shire) Protocol # SHP621-301, 2014-Present; Oral budesonide suspension (OBS) in Adolescent and Adult Subjects (11 to 55 years of age inclusive) with Eosinophilic Esophagitis, EOE: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study.

PFIZER Pharmaceutical Corp. Inc. Protocol # A7281007, 2013-Present; A Phase 3, Multicenter Open-Label Extension Study for PF-00547659 (OPERA II) Subjects with Crohn’s Disease.

SHIRE ViroPharma, Incorporated (Shire) Protocol # SHP621-302, 2014-Present; A Phase III, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) with Eosinophilic Esophagitis (EOE) has been amended.

THE INTERNATIONAL CENTER FOR INDIGENOUS PHYOTHERAPY STUDIES, Inc. (TICIPS), Protocol # TICIPS001, 2014-Present; A Phase 1, 2, 3 & 4 Randomized, Double-Bling, Placebo-Controlled, Study to Investigate the Safety of Sutherlandia Frutescens (Subspecies Microphylla) in Healthy Adult Volunteers.

REDHILL Biopharma, Inc. Protocol # RHB-104-01, 2016-Present; A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104-01 in Subjects with Moderate to Severely Active Crohn’s Disease.

PFIZER Pharmaceutical Corp. Inc. Protocol # C1231006, Pharmerit Protocol # 16211 31MAR2017-Present; A Phase IV Observational, Real-World Study of Inflectra in patients with IBD. ONWARD is a prospective, Observational, Multi-Center Study conducted in Adult patients with Ulcerative Colitis or Crohn’s Disease.

BRISTOL MYERS SQUIBB Corp. Inc. Protocol # MB130-059, A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Non-Alcoholic Steatohepatitis (NASH) And Stage 3 Liver Fibrosis;

And

BRISTOL MYERS SQUIBB Corp. Inc. Protocol # MB130-060, A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MBS-986036 (PEG-FGF21) in Adults With Non-Alcoholic Steatohepatitis (NASH) And Compensated Liver Cirrhosis.

SALIX Pharmaceuticals, Inc. Protocol # RECD3125, 2014-Present; A Phase 3 & 4, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 weeks in Subjects with Active Moderate Crohn’s Disease.

ABBVIE LEGACY REGISTRY, UC - Protocol # P11-282, 2013-Present; A Long-Term, Non-Interventional, Registry to Asses Safety and Effectiveness of Humira (Adalimumab) in Patients with Moderate to Severely Active Ulcerative Colitis (UC).

UCB Biopharma SPRL, Protocol # MJFF-001, 2014-Present; A Non-Randomized Sample-Collection/Methods Development Study, With Two Study Visits, (collection periods) To Determine the Diurnal Fluctuations of Specific Biomarker candidates (including a-synuclein) in the blood and Cerebral Spinal Fluid (CSF).

CELGENE CORPORATION, Inc. Protocol # CC-10004-UC-001, 2014-Present; Amendment 2; A Phase 2, Randomized, Placebo-Controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects with Active Ulcerative Colitis Disease (UC).

PFIZER Corp, Inc. Protocol # A7281006, 2013-Present; A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Crohn’s Disease Who Are Anti-TNF Inadequate Responders (OPERA).

ABBVIE, Inc. Protocol # AbbVie M13-740, 2013-2016; A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn’s Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.

SALIX Pharmaceuticals, Inc. Protocol # RFIB3053, 2013-Present; A Phase 2, Study to Assess Repeat Treatment to Evaluate the Efficacy and Safety of RIFAMIMIN 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-d).

GLAXOSMITHKLINE / ROBARTS, Inc. Protocol # CCX114151, 2013-2016; A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of GSK 1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease.

NIH, Protocol # 06-158

Gait And Step Training To Prevent Fall in Parkinson’s Disease Subjects.

CLINICAL RESEARCH EXPERIENCE:

Certified Clinical Research Associate; Pasadena Gastroenterology Associates, dba Digestive Health Center; August 2016 - Present; Pasadena, TX

Responsible for performing project activities associated with site management and monitoring in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPs. Require minimum supervision for assigned responsibilities. Works as part of a team to create and implement tools (e.g. checklist / trackers) to help monitors improve efficiency at site. Responsible for participating in sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings. Coordinate projects and provides administrative support for program activities for all of the department’s assigned Clinical Trial Programs. Well verse and knowledgeable regarding pharmaceutical protocol submission processes, formatting requirements, meeting assigned deadlines and confident in dealing with regulatory issues. Responsible for utilizing technical writing skills to compose and abstract medical and scientific information for preparation of written correspondence(s), reports and other documents under the direction of the Principal Investigators, Managers, Departmental Heads, Supervisors with Team Leads where necessary. Convene and interacts with protocol sponsors, CRO, industry personnel, government representatives, and cooperative groups on projects. Responsible for coordinating collaborative meetings and other communications with the Principal Investigator and clinical trial sponsors to evaluate and audit existing studies and make the necessary recommendations to improve ongoing processes. Coordinate and prepares assigned protocols and amendments for successful submission to the internal and external systems. Attends departmental research program meetings, assist in providing oversight and supports all the designated site-specific research programs and committees as needed. Responsible for coordinating, revising, developing and composing key and supporting documents for investigator-initiated clinical trial protocols and associated projects. Directs and works closely with Project Manager, Innovative Therapies to prepare data, create reports and other information for Research Administration Committee (RAC), DT, EDDIT and other meetings. Transcribes sponsored trials into the required client’s required formats. Responsible for providing ongoing support to investigative sites to facilitate the conduct of the study. Confers and interfaces with internal departments and external programs, committees, with different boards on assigned projects. Responsible for ensuring that all regulatory and institutional requirements are met before study activation is commenced. Coordinates phase I-IV breast cancer (oncology) trials with (4 active and 2 to follow up studies). Supports the goals of the General Medical organization by PSSV, site initiation, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Client’s SOP’s and ensuring that study milestones are met. Monitors all patients in the studies with oncology, neurological and other issues for follow-up. Leads all central point of communication between Client’s and investigational sites for all oncology, neurological with other clinical trial related activities. Experience in Oncology observational trials; Late-phase II studies (Phase IIIb/IV), constitute a rapidly expanding segment of the clinical research environment as the biopharmaceutical marketplace undergoes dramatic subsequent changes. Does Observational Research studies on groups of patients within oncology routine clinical practices to provide valuable insights into a casual association between a treatment (e.g. a device, drug product, or procedure) and an event or outcome (e.g. safety and long-term effectiveness): including Case-control studies, retrospective chart reviews, prospective Patient Registries, Cohort study designs, Database studies using electronic health records (EHR), electronic medical records (EMR); and third party databases. Observe and evaluate the safe and effective use of an Electro-Mechanical Injection Device (E-Device) For The Subcutaneous Self-Injection Of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis. Advise Principal Investigator on oncology decisions such as trial acquisition, advertising and patient interactions. Coordinates refresher training on company’s SOPs to partnering Study Managers. Conduct studies across multiple therapeutic areas and trial sites, my experience encompasses different types of peri-approval and post-marketing studies including: risk management, patient registries, expanded access programs, health economic studies, pharmacoepidemiology, comparative effectiveness research, health-related quality of life studies, on-going pharmacovigilance studies; and Observational (non-intervention studies). Responsibilities includes overseeing Oncology monitoring clinical trial study and regulatory operations including startup, maintenance and closeout for multiple multi-center, clinical research studies, protocol compliance, regulatory documentation, quality control, data monitoring and reporting, Institutional Review Board (IRB) submissions, coordination of invoicing with administration and assist in the supervision of some coordinator activities. Conduct site assessments, including site activation, interim monitoring and close-out visits. Assist in leading support of Observational Research study operations including tracking and overseeing overview of subjects, site, study status, milestones and performing quality check activities across components of the clinical study. Mentors CRAs, Trial Lead CRA role when assigned. Performs additional roles and functions for PI as assigned; such as participating in meetings, travelling/leading special project initiatives and committees. I’m an essential contributor for the assessment and development of processes, Coordinate & Observe Phase IV randomized clinical trial for the treatment of Oncology Obese patients for IBS, GERD, IBD, and EoE; and led study team planning for an IDE study. Participated in Site selection, monitoring and ongoing site/investigator support. Develops and manages the budget, timeline, monitoring schedule, and all monitoring activities. Responsible for maintaining knowledge of GCP, GEP, GPP and all applicable Regulations as required. Coordinate Institutional Review Board/Ethics Committee (IRB/EC) approvals, as appropriate for ophthalmology clinical trial. Responsible for traveling to conferences for research studies representing the PI.

Clinical Research Associate; February 2014 - August 2016 BMI Healthcare, Silver Spring, MD

Collaborated with Pharmacists and Medical Oncologists to build and manage patient treatment plans. Assisted the Lead Study Manager and the clinical team in Observational Research day to day activities for clinical studies, conduct, support completion per established team goals and objectives. Provides support and database maintenance for ongoing research programs in database reviews and developing reports and tables documenting ophthalmology clinical trial study status. Write and distribute site visit reports, and tracks resolution of outstanding issues. Monitored the progress of multiple clinical studies at investigative sites, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Collaborated with cross-functional study team members and ensured compliance of study activities with FDA regulations, guidelines, and principles of ICH GCP and firm’s SOPs for Observational Trial Study. Monitor overall ophthalmology progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites and clinical trial team members. Coordinated external relationships with clinical trial site contacts and vendors as needed to support business objectives for various departments. Collected, distributed and tracked receipts of regulatory and other trial related documents through the life cycle of the clinical trial as needed. Worked and reports to Associate Manager, Manager of Site Management (SM) within Clinical Trial Management (CTM); and Project Manager for all related study activities. Informed patients and families of any neurological diseases and provided cost of treatment as per protocol and study guidelines. Accountable for actively participating in internal cross functional teams locally/globally to ensure the effective delivery of assigned project milestones. Compiled key study information from various systems into a report format for tracking metrics for study team. Independently prepared and performed Investigator site visits relevant to the phase of the study (selection and qualification, initiation, regular monitoring or site closure) as specified in the Project Plan and Monitored Guidelines. Worked with research operational staff that helps to define the needs of target audiences to develop the best study designs to achieve research objectives. Distributed and tracked reports to clinical trial sites and IRBs. Created and maintained logs of trial related documents. Distributed & tracked protocol deviations. Abstracted data from necessary sources to complete the EDC and resolve queries.

Clinical Research Assistant/Recruiter; Feb 2013 - Feb 2014 Overreacher Empire Clinicals, Silver Spring, MD

Monitor overall ophthalmology progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites and clinical trial team members. Recruited and scheduled patients for studies, completed patient questionnaires and collected additional study data on routine basis; dispensed medications and monitored patients for adverse effects and serious adverse effects. Responsible for and assisted in the informed consent process, screened potential patients for adult oncology clinical trials; assessed treatment patients for toxicities, dose modifications, and serious adverse events. Compiled IRB/EC submission documents. Distributed tracks, collates and summarized feasibility information and provided to study team as needed. Ensured compliance with the applicable guidelines and regulations (FDA CFR21/EU CTD/ICH-GCP); and communicated to all policies, procedures and fundamentals. Generated potential site information from investigator database. Reported any findings related to the study to Project Managers responsible for the respective studies. Maintained trackers for essential trial related documents as needed. Recruited and prescreened subjects to determine if they qualify to participate in various research studies based on the specifications set forth by the pharmaceutical, cosmeceutical, laser manufacturers and clinical research organizations conducting the research trials. Worked with cutting edge Physicians and Research Team to continue the tradition of top ranked patient care and support. Assisted CRCA and CRC with assigned administrative duties as needed. Generated candidates through a pool by sourcing, cold calling, referrals, mailings, database lists, seminars, job fairs, conventions, social media, and professional meetings. Developed and executed recruitment and retention plans, with an excellent ability to conduct in-depth, behavior-based interviews. Had a solid understanding of how to read and report on recruitment KPI’s: Retention, Cost per time to fill, Open reqs., source of hires, etc. Reviewed candidate’s references and interview with the appropriate department and pinnacle management. Accustoms to high volume of requisition load, executes over 35 requisitions at any given time; with a solid client relationship building and customer service mind-set. Proficiency with MS Programs, and Applicant Track Systems.

Loan Officer; December 1990 - February 2013 Oxford Realty Mortgage Corporation, Houston, TX

Conferred with escrow companies, lenders, home inspectors, and pest control operators to ensure that terms and conditions of purchase agreements are met before closing dates.

EDUCATION Strayer University, BS, Computer Engineering/Industrial Management & Business Studies 12/90

Certification: CCRA, Certified Clinical Research Associate, Clinical Research Training Online, Wallingford, PA

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