Kamaljit Dhaliwal

West Palm Beach, FL

561-***-****

ad0srv@r.postjobfree.com

With over two decades of experience in clinical trial monitoring and a demonstrated commitment to maintaining regulatory requirements, I am passionate about improving the quality of clinical research and driving results in research teams. As an expert in clinical research education and training, I am seeking a new opportunity to leverage my skills and experience to lead studies and enhance patient outcomes in a management or senior role within the clinical trial industry. Work Experience

Senior Clinical Research Associate/Clinical Research Director 9/2017 to 10/2023

Certified Clinical Research Professionals Society

Jacksonville, FL 32206

" Developed and implemented comprehensive training programs for clinical research personnel.

" Ensured all training programs were compliant with ICH GCP guidelines.

" Designed and led workshops and seminars on clinical research best practices.

" Analyzed program effectiveness, evaluated performance metrics and feedback from trainees.

" Collaborated across teams to develop standardized trainingmaterials.

" Assisted in developing best practices for site management/monitoring.

" Served as subject matter expert for clinical research training programs, leading sessions.

" Identified continuous improvement opportunities for knowledge/skills of personnel.

“Successfully managed and monitored multiple phase I-IV clinical trials, remotely” Senior Clinical Research Associate

02/2017 to 08/2017

Miller School of Medicine University of Miami

1550 NW 10th Ave #118, Miami, FL 33136

" Led execution of 3 clinical trials for Phase II Ovarian Cancer, Interventional Neurosurgery Trial, and Phase II-II Stem Cell Research Trials, adhering to protocol and ethical standards

" Conducted risk assessments and mitigation plans to minimize potential study issues

" Mentored and trained junior Clinical Research Associates on ICH-GCP guidelines

" Coordinated with the Clinical Operations team to arrange site visits, monitoring visits, and protocol review meetings

" Developed and reviewed documents such as protocols, informed consent forms, case report forms, & monitoring plans

" Conducted pre-study assessments & site qualification visits to evaluate potential study sites

" Monitored progress of clinical trials regularly & identified potential issues to promptly resolve

" Maintained accurate & complete study documentation&ensured compliance with regulatory requirements & Good Clinical Practice guidelines

“Collaborated with the Data Management team to ensure accuracy & completeness of data & resolved data discrepancies in a timely manner

" Provided regular updates and reports to the study team and other stakeholders Senior Site Manager / Senior CRA

11/2014 to 10/2016

PRA Health Sciences / Merck

John Hopkins, UVA, Georgetown, Medstar Cancer Institutes

" Successfully managed and monitored multiple Phase I, II, and III oncology trials at prestigious institutions compliant with ICH-GCP guidelines.

" Conducted feasibility, site selection, interim, and close-out visits to ensure effective site management.

" Detected and promptly resolved site issues by implementing corrective action plans; delivered training when necessary.

" Maintained tracking records to ensure integrity of clinical data; reviewed completed eCRFs for accuracy.

" Built strong working relationships with Clinical Operations Group and other departments.

" Assisted in reviewing TMF to ensure maintenance and archiving of files; monitored investigational and comparator drug supply during trial.

" Delivered successful outcomes by managing andmonitoring trials, interpreting data, providing insights into analysis, reporting unexpected data.

" Accomplished cross-functional communication withSponsor; effectively managed Investigator meetings leading to successful trial delivery/improved site performance.

" Fostered positive relationships with clinical trial sites increasing retention rates/communication resulting in fewer issues/timely resolution.

Lead Senior Clinical Research Associate

01/2014 to 09/2014

Clinipace Worldwide

3800 Paramount Pkwy, Suite 100 Morrisville, NC 27560

" Supervised a team of Clinical Research Associates for Teratologic Ovarian Cancer and Phosphate Therapeutics inChronic Kidney Disease studies, ensuring adherence to study protocols, SOPs and ICH-GCP principles.

" Supported selection and initiation of study sites, and monitored pharmacovigilance activities throughout the trial.

" Reviewedmonitoring reports, provided guidance/training to CRAs inmonitoring techniques/documentation, andoversaw supply of investigational drugs throughout the trial.

" Established effective communication with stakeholders to resolve issues and ensure timely corrective actions.

" Developed quality control procedures & monitored team’s performance, fostering continuous process improvement.

" Committed to highest ethical standards, scientific rigor & data integrity in clinical trial conduct. Senior Clinical Research Associate

06/2011 to 01/2014

ICON Clinical Research

2100 Penn brook Pkwy, North Wales, PA

" Spearheaded the successful initiation and closeout of multiple clinical trials in the US and Canada for BMS-Diabetes, Elli Lilly-Diabetes, and Novartis-Influenza.

" Conducted site identification and selection process to ensure high qualitysites.

" Coordinated study startup activities and Investigator Meetings to align international sites.

" Expertise in data management, accurately reviewing eCRFs, TMFmaintenance and archiving.

" Contributed to the ongoing review of ICON systems and procedures for continual optimization

“Collaborated with cross-functional teams to provide guidance throughout trial duration.

" Maintained knowledge of regulations and guidelines, meeting or exceeding timelines with ethical standards.

" Oversaw supply of investigational drugs throughout trial, maintaining accurate records per protocol/GCPs.

" Established effective communication withall stakeholders, resolving issues/implementingcorrective actions promptly.

" Developed quality control procedures, monitored team performance and facilitated continuous process optimization. Paramedical Examiner

07/2010 to 06/2011

APPS Northwest

8285 SW Nimbus Ave, Suite 171, Beaverton, WA

" Administered accurate patient/client medical exams and collected blood samples, demonstrating exceptional skill inall aspects.

" Conducted EKGs with precision and speed, effectively navigating complex cardiac technology.

" Recorded detailed patient medical histories, answering questions with tact, sensitivity, and clarity.

" Upholding strict ethical and legal standards related to patient privacy and confidentiality.

" Maintained superior level of organization and efficiency in administrative tasks.

" Successfully managed a high-volume caseload at all times, managing competing priorities for optimal care standards.

" Provided clear communication regarding medical procedures to patients/clients using empathetic strategies for satisfaction.

" Staying current on advances by attending training sessions and continuing education courses to improve skills & knowledge.

Sub Investigator / Director of Medical Affairs

12/2009 to 07/2010

Northwest Clinical Research Center

1951 152nd Pl NE #200, Bellevue, WA 98007

" Spearheaded clinical evaluation and scientific analysis of proposed trials, ensuring alignment with company objectives and compliance with ICH/GCP guidelines.

" Directed pre-study evaluations and provided protocol-specific training to staff.

" Supervised, managed and collaborated with CROs/vendors to identify optimal partners.

" Provided scientific guidance in the design and interpretation of clinical studies.

" Establishedstrongworking relationshipswithcross-functional departments.

" Evaluated inclusion/exclusion criteria, conductedsubject recruitment/consenting processes, performed assessments at every follow-up visit as required by trial.

" Reviewed source documents & quality assurance after each subject visit.

" Assessed adverse and serious adverse events following protocol procedures for assessment & management.

" Attended Investigators Meetings to provide expertise & insight to advance success of trials.

" Successfully managed all closeouts, delivering high-quality results that met expectations of NWClinical Research Center and its stakeholders.

Senior Clinical Research Manager / CRA

06/2008 to 12/2009

NOR Consult/AO Spine

677 Strander Blvd. Suite F Tukwila, WA 98188

" Management and expert role during successful start-up of clinical research organization at AOSpine NOR Consult LLC, ensuring efficient development of CRO and management of clinical trials.

" Provided expert oversight and guidance in the strategic planning and implementation of clinical development programs in neurology, oncology, and cervical/lumbar fusion device therapeutic areas.

" Developed and executed training programs for site personnel to ensure comprehensive understanding and compliance with study protocols.

" Ensured timely data collection and monitoring from assigned investigational sites with appropriate measures.

" Managed CRFs, providing feedback to data management/investigational sites to improve overall accuracy/integrity.

" Collaborated cross-functionally with internal/external stakeholders to ensure timely execution/completion of clinical trials.

" Demonstrated strong leadership, organizational, and communication skills in supervision/management of teammembers. Clinical Research Director

03/2007 to 03/2008

Chevy Chase Clinical Research

5550 Friendship Blvd t90, Chevy Chase, MD 20815

" Spearheaded clinical research programs for Gastrointestinal Disorders and Infectious Diseases at Chevy Chase Clinical Research.

" Developed clinical study designs, protocols, and ensured compliance with regulatory agencies and ethical standards.

" Generatedandanalyzedclinical data, interpreted results, generated clinical claims/advertising/promotional opportunities.

" Collaborated with cross-functional teams to provide medical/scientific expertise in assessing/interpreting data.

" Generated quality research publications and presentations to enhance the scientific reputation of Chevy Chase Clinical Research.

" Built strategic relationships with KOLs, investigators, academic institutions to facilitate their participation in research initiatives.

" Supervised a team of trial managers, project managers, medical writers & biostatisticians to ensure successful completion of trials within allocated budgets.

Clinical Research Associate/ Pharmacovigilance Officer 09/2002 to 03/2007

Medical Associates of Northern Virginia

611 S Carlin Springs Rd Ste 504 Arlington, VA 22204

" Conducted dozens of clinical trials in compliance with ICH/GCP guidelines, ensuring data collection and analysis.

" Managed safety concerns, maintained risk-benefit assessments, and provided medical/scientific representation oncross- functional teams.

" Mentored and supervised junior staff members, resulting in a high-performingteam.

" Established & maintained relationships with Health Authorities, serving as the primary point of contact for medical and clinical issues.

" Provided medical/clinical guidance to managers & cross-functional teams.

" Conducted safety assessments including medical review of adverse event reports & signal detection.

" Ensured regulatory compliance and timely submission of periodic reports to FDA, including annual safety reports & IND safety reports.

" Conductedmedical/causality assessments of all clinical/post-marketing adverse event filings to foreign regulatory authorities.

MD- Doctorate in Anesthesiology and Critical Care

Post Graduation Medical Training and Research

09/1999 to 09/2002

Government Medical College

Government Medical College, Circular Road, Amritsar 143001 India MBBS

8/1988-8/1993

Bachelor of Medicine and Bachelor of Surgery 1987-1993 Medical College Patiala, Punjab, India.

BSc

8/1985-8/1988

Bachelor of Science, Government College for Women; Punjab India. Community Health Medical Officer

11/1995 to 09/1999

Department of Health and Family Welfare

Punjab, India

" Developed and implemented community health programs for the prevention and control of infectious diseases, leading to a reduction in morbidity and mortality rates.

" Conducted clinical trials and studies on pneumococcal vaccines, yielding immunization strategies and recommendations for the community.

" Led team of healthcare professionals in conducting health education campaigns to increase awareness of safe practices among target population.

" Analyzed data to inform policymaking at local and state level, ensuring evidence-based interventions.

" Collaborated with stakeholders to leverage resources and best practices for advancing health outcomes in underserved populations.

" Demonstrated strong communication, interpersonal, problem-solvingskills tomanage challenging situations given epidemics and disasters.

" Education

MD-Doctorate Anesthesiology and Critical Care Punjab, India. MBBS- Bachelor of Medicine and Bachelor of Surgery BSc-Bachelor of Science

Skills

Proficient in MS Word and Excel

Communication Skills

Interpersonal Skills

Attention to Detail

Relationship Management

Critical Thinking

Time and Stress Management

eTMF/CTMS

Well versed with the following electronic trial master file systems: ORACLE

ClinPlus

Medidata-Rave

Egnyte

Viedoc

Databases

Used the following databases:

ClinicalTrials.Gov

PubMed

MEDLINE

TGCA-The Cancer Genome Atlas

EORTC

WHOICTR-International Clinical Trials Registry Platform Search Portal. Summary of Clinical Trials Conducted

As a Clinical Research Associate (CRA), I have conducted several trials across different specialties. These trials have been organized into their respective specialties for better understanding and clarity. Musculoskeletal Trials:

Two companies- Cerapedics and AOSpine - have conducted clinical trials in musculoskeletal areas. Cerapedics has conducted two trials using their P 15 Bone Putty in Anterior Cervical Discectomy and Extension, both in phase III and IV respectively. AOSpine, on the other hand, has conducted a prospective controlled cohort study called MESCC (Metastatic Epidural Spinal Cord Compression) and CSM (Cervical Spondylotic Myelopathy). These trials aim to find new and advanced treatments for musculoskeletal issues like spinal cord compression and spondylotic myelopathy. Neurology and Psychiatric Trails: Conducted various clinical trials in treatment of resistant depression. NIMH has carried out an observational study of rapid-cycling bipolar disorder patients, while the institute has also conducted research to gauge the effectiveness of supplemental calcium in post-partum depression and treating Neurology/Psychiatric Trials: National Institute of Mental Health (NIMH), Pfizer, and Johnson and Johnson have conducted clinical trials in Johnson aimed to find the efficacy of Risperidone obsessive-compulsive disorder. GI Trials:

Abbott’s Humira has conducted a phase III clinical trial to find solutions for ulcerative colitis, while Otsuka and Medarex studied Crohn’s disease and ulcerative colitis, respectively. Reliant Pharmaceuticals conducted a phase IV study on Irritable Bowel Syndrome (IBS) patients and analyzed IBS and its impact on the human body. Endocrinological Trials:

Several companies have conducted clinical trials to find new treatments for diabetes. Novartis, Elly Lilly, and BMS have conducted phase III trials, while Aventis has conducted phase IV trials. The other trial in Endocrinology was to find anemia of chronic kidney disease carried out by Kendle.

Rare Diseases: Acoustic Neuroma, Acquired Hemophilia, Acromegaly, Anemia of Chronic Kidney Disease, Trigeminal Neuralgia, etc.

neurology/psychiatric areas. Pfizer has conducted trials of Robexetene in patients with fibromyalgia, while Johnson and Oncology Trials:

Several companies, including Sanofi Aventis, Amgen, and Tetralogic, have conducted clinical trials to find treatments for cancer. These companies have conducted trials to address advanced renal cell carcinoma, colorectal cancer, ovarian cancer, breast carcinomas, pancreatic carcinoma, urogenital carcinoma, mandibular and maxillofacial carcinomas and melanomas. Conducted various Hematology and Oncology trials as well. Cardiovascular Trials:

AstraZeneca conducted trials for atrial fibrillation and hypercholesterolemia. Boehringer Ingelheim conducted a clinical trial to find a treatment for hypertension, along with two more hypertension trials by BERTEK and INVEST_UFL, respectively. AstraZeneca has also conducted clinical trials to find a cure for hypertension in phase IV. Ophthalmology- 4 years.

Other Specialties:

Several companies conducted clinical trials for other obscure specialties. Kendle conducted a clinical trial for lower respiratory tract diseases, and Ortho McNeil was involved in a clinical trial to develop treatments for bronchitis. Ferring Pharmaceuticals researched osteoarthritis, and Wyeth aimed to develop cures for migraines. Solvay conducted a clinical trial aimed at finding solutions for IBS, while Guru Nanak Medical College conducted research on the Combitube device study to treat respiratory diseases, and Biocryst aimed to find a cure for Influenza. In conclusion, these clinical trials have contributed significantly to finding innovative solutions and treatments across various specialties concerning human health. As a CRA, I have found myself fortunate enough to be involved in these groundbreaking trials and to have played my part in bringing about a positive change in people’s lives. Certifications / Licenses

Advanced Clinical Research Associate Certification 01/2019 to 03/2023

" Successfully completed Clinical Research Associate certification course, becoming well-versed in industry standards and guidelines.

" Developed and facilitated training programs for fellow educators, incorporating research findings and best practices.

" Collaborated with cross-functional teams to identify opportunities for process improvement.

" Demonstrated strong project management skills, consistently meeting or exceeding project milestones and deadlines.

" Received positive feedback from internal and external stakeholders for high-quality training programs and support services.

" Utilized effective communication skills to effectively train and support diverse audiences.

" Regularly evaluated programs based on feedback, continually improving course content and delivery methods. Clinical Research Management Certification - CCRPS 02/2021 to 03/2023

" Gained expertise in clinical research management with successful completion of certification provided by employer.

" Trained fellow employees and external clients in relevant regulations and guidelines, fostering critical thinking skills with case studies and discussions.

" Coordinated with cross-functional teams to design and execute effective clinical research strategies for successful project completion.

" Demonstrated excellence in data analysis, project management, and communication to lead projects within deadlines.

" Ensured quality control standards were met throughout research and documentation processes.

" Stayed up-to-date on industry trends, attending conferences and trainings to advance professional knowledge.

" Collaborated with medical writers, statisticians, and drug safety professionals to ensure regulatory compliance in clinical trials.

Pharmacovigilance and Drug Safety Certification - CCRPS 09/2019 to 03/2023

" Successfully completedand passedAdvanced Pharmacovigilance andDrugSafety Certification.

" Obtained IAOCR accreditation.

" Served as an internal educator and developer, continuously updating and enhancing the curriculum.

" Trained and mentored numerous professionals in the field of pharmacovigilance.

" Designed and delivered customized training programs resulting in positive feedback.

" Developed and implemented new processes and tools to streamline workflows.

" Demonstrated exceptional project management skills ensuring all aspects of clinical research projects are completed on time which budget with high quality standards.

" Maintained up-to-date knowledge of emerging trends, regulations, and best practices within the clinical research space. ICH GCP Certification - CCRPS

06/2020 to 03/2023

" Successfully obtained ICH GCP certification provided by employer, showcasing my commitment towards staying up-to- date with industry standards and regulations.

" Utilized my knowledge and experience as an educator and developer to develop and conduct a comprehensive ICH GCP training course for colleagues, enabling them to meet clinical trial requirements and improve overall performance.

" Incorporated new guidelines and revisions into the training course, ensuring that our team was always fully informed and equipped to handle any regulatory updates or changes.

" Received outstanding feedback from participants in the ICH GCP training course, with many expressing gratitude for the clear, concise, and engaging delivery of the material.

" Continuously sought out new resources and materials to supplement the ICH GCP certification course, enhancing the overall value and relevance of the program.

" Improved the overall level of compliance with regulatory guidelines and requirements across the organization, helping to ensure the safety and well-being of clinical trial participants.

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