Clinical Research Associate

Benjamin A. Adetunji

Charlotte, *****, United States, +1-708-***-****, *******@*****.***, linkedin.com/in/benjaminadetunji-364b06159/

SUMMARY Dynamic Clinical Research Professional with over 20 years of extensive

experience in clinical research management, site operations, and team leadership. Proven expertise as a Clinical Research Associate and Site Manager, with a strong focus on adhering to Good Clinical Practice (GCP) and regulatory requirements. Successfully led teams to enhance patient recruitment and data integrity in clinical trials. Skilled in stakeholder collaboration and project management, poised to contribute impactful strategies and innovative solutions to advance clinical research initiatives.

WORK EXPERIENCE

11/2022 – 12/2024 Clinical Research Associate, Fortrea (formerly LabCorp) Remote, USA

Conducted site initiation visits, meticulously ensuring compliance with study protocols and regulatory requirements.

Performed routine monitoring visits to clinical trial sites, rigorously verifying data accuracy and adherence to Good Clinical Practice (GCP) guidelines. Collaborated with investigators and study coordinators to facilitate timely enrollment of eligible patients into clinical trials.

Reviewed source documents, case report forms (CRFs), and electronic data capture (EDC) systems for completeness and accuracy. Managed investigational product accountability at the site level, encompassing storage, dispensing, reconciliation, and return/disposal processes.

Delivered comprehensive training on protocol requirements, study procedures, and data collection tools to site staff members.

Monitored adverse events reported by study participants or identified during site visits, promptly communicating findings to the sponsor. Maintained meticulous documentation of all monitoring activities in accordance with company SOPs and regulatory guidelines. Assisted in the preparation of regulatory submissions for ethics committees/institutional review boards (IRBs).

Participated in investigator meetings, contributing valuable input on protocol design, feasibility assessments, and recruitment strategies. Contributed to the development of study-specific monitoring plans based on robust risk assessment principles.

Ensured compliance with local regulations regarding the informed consent process, rigorously reviewing informed consent forms for clarity and completeness.

07/2016 – 11/2022 Clinical Research Site Manager, Carolinas Research Center Charlotte, USA

Managed and oversaw the planning, execution, and completion of multiple clinical research projects.

Developed and implemented project timelines, ensuring strict adherence to milestones and deliverables.

Led a team of XX clinical research professionals in executing various phases of clinical trials.

Collaborated with cross-functional teams including physicians, scientists, regulatory affairs, and data management to guarantee successful study outcomes.

Implemented robust quality control measures to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. Negotiated contracts with sponsors, optimizing resources while maintaining budget constraints.

Formulated standard operating procedures (SOPs) for the site, guaranteeing consistency across all research studies.

Ensured timely submission of required documentation to regulatory authorities for the approval of new studies or amendments to existing protocols.

Participated in investigator meetings and scientific conferences, presenting trial results or providing updates on ongoing studies.

Provided training and mentorship to clinical research staff, fostering professional development and adherence to industry standards. Ensured compliance with applicable regulatory requirements, including International Conference on Harmonization - Good Clinical Practice (ICHGCP) and FDA regulations.

10/2014 – 08/2015 Clinic Site Manager, Biofortis Merieux NutriSciences Addison, USA

Managed and oversaw the planning, execution, and completion of multiple clinical research projects.

Developed and implemented project timelines, ensuring adherence to milestones and deliverables.

Led a team of XX clinical research associates in conducting various phases of clinical trials.

Collaborated with cross-functional teams, including physicians, scientists, regulatory affairs, and data management to ensure successful study outcomes.

Implemented quality control measures to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. Oversaw site selection processes for study protocols based on criteria such as patient population demographics and infrastructure capabilities. Formulated standard operating procedures (SOPs) for the site, ensuring consistency across all research protocols.

Conducted thorough risk assessments for each trial phase to identify potential issues or challenges that may impact study timelines or objectives.

Managed data collection processes, ensuring prompt entry into the EDC. Ensured timely submission of essential documentation to regulatory authorities for approval of new studies or amendments to existing protocols.

Participated in investigator meetings or scientific conferences, presenting trial results or providing updates on ongoing studies.

Maintained effective communication channels between internal stakeholders, including sponsors, investigators, and contract research organizations (CROs).

Identified and resolved issues or conflicts that arose during the course of clinical trials, ensuring timely resolution and minimal impact on study timelines.

Provided training and mentorship to clinical research staff, ensuring professional development and adherence to industry standards. Instituted electronic data capture (EDC) systems for efficient data collection, management, and analysis.

Ensured compliance with applicable regulatory requirements, such as International Conference on Harmonization - Good Clinical Practice (ICHGCP) and FDA regulations.

Maintained up-to-date knowledge of current industry trends, best practices, and emerging technologies in clinical research.

Served as a liaison between sponsors, investigators, and regulatory authorities throughout the entire study lifecycle.

01/2003 – 06/2014 Director of Operations, Illinois Center for Clinical Research Chicago, USA

Oversaw all aspects of operations for the organization, including budgeting, staffing, and performance management.

Implemented strategic initiatives to enhance operational efficiency and reduce costs.

Led cross-functional teams to develop and implement standard operating procedures (SOPs), ensuring consistency and quality across all study protocols.

Instituted safety protocols and training programs that resulted in a significant decrease in workplace accidents.

Conducted regular audits of operational processes, ensuring compliance with industry regulations and company policies.

Developed key performance indicators (KPIs) for each unit to track progress towards operational goals.

Managed the recruitment, onboarding, training, and development of staff members across multiple locations.

Spearheaded the implementation of new platforms, such as PET and online patient questionnaires and payments, to streamline operations. Devised contingency plans for potential disruptions, such as natural disasters or supplier issues.

Formulated and implemented employee training programs to enhance skills and knowledge within the organization.

01/2003 – 05/2005 Clinical Research Coordinator, Illinois Center for Clinical Chicago, USA

Research

Coordinated and managed clinical research studies, ensuring strict adherence to protocols, regulatory requirements, and timelines.

Recruited and screened eligible participants for clinical trials, maintaining accurate records of enrollment and eligibility criteria.

Scheduled study visits, procedures, and follow-up appointments with participants in accordance with study protocols.

Collected and recorded data accurately and promptly using electronic data capture systems or case report forms (CRFs).

Maintained comprehensive study documentation, including informed consent forms, source documents, and regulatory binders.

Assisted in the preparation of Institutional Review Board (IRB) submissions for new studies or protocol amendments.

Collaborated with investigators to develop study-specific tools such as questionnaires or surveys.

Ensured compliance with Good Clinical Practice (GCP) guidelines throughout the conduct of clinical trials.

Managed investigational product accountability, including receipt, storage, dispensing, reconciliation, and return/destruction processes.

Coordinated site initiation activities, including conducting training sessions for site staff on study procedures and protocol requirements.

Provided ongoing support to investigators by addressing queries related to study procedures or participant management issues.

Developed effective recruitment strategies in collaboration with the recruitment team, resulting in an increase in participant enrollment in studies.

Led regular meetings with cross-functional teams, including investigators, sponsors/vendors, and laboratory personnel, ensuring effective communication throughout each trial.

Tracked project milestones using project management tools/software, ensuring timely completion of deliverables.

Coordinated with clinical research associates (CRAs) to ensure timely resolution of data queries and discrepancies.

Provided training and guidance to new team members on study protocols, procedures, and documentation requirements.

Maintained up-to-date knowledge of relevant regulations, guidelines, and industry best practices related to clinical research coordination. Collaborated with cross-functional teams, including data management, biostatistics, and medical writing to ensure successful completion of studies.

Demonstrated strong attention to detail in reviewing source documents for accuracy and completeness during monitoring visits.

01/2003 – 01/2005 Clinical Preceptor, Affiliated Institute for Medical Education Chicago, USA

Developed and implemented engaging lesson plans that catered to diverse learning styles and abilities.

Utilized various instructional strategies, such as cooperative learning, hands-on activities, and technology integration, to enhance student engagement and comprehension.

Assessed student progress through regular formative assessments, quizzes, tests, projects, and presentations.

Analyzed assessment data to identify areas of improvement and tailored instruction accordingly.

Integrated technology tools (e.g., educational apps) into daily instruction for enhanced student engagement.

Designed and implemented project-based learning experiences that fostered critical thinking, problem-solving, and collaboration skills.

07/2002 – 12/2002 Laboratory Scientist, Pathology Diagnostics Maywood, USA

Performed a wide range of laboratory tests and procedures, ensuring accuracy and precision in the analysis of samples.

Operated and maintained laboratory equipment and instruments, troubleshooting any issues to ensure proper functioning.

Conducted quality control checks on equipment, reagents, and test results to maintain high standards of accuracy and reliability.

Collected, processed, and analyzed several types of biological samples, such as blood, urine, and tissue specimens.

Interpreted test results accurately using knowledge of scientific principles and medical terminology.

Maintained detailed records of all tests performed, including patient information, test methods used, and results obtained.

Ensured compliance with regulatory requirements by always adhering to standard operating procedures (SOPS).

Managed inventory levels by monitoring supplies usage patterns and placing orders when necessary to avoid shortages.

Investigated abnormal test results through troubleshooting techniques, contributing to accurate diagnosis for patients.

Maintained a clean and organized work environment, strictly adhering to safety guidelines and biohazard waste disposal procedures.

Ensured proper handling, storage, and disposal of hazardous materials in compliance with regulatory standards.

05/1990 – 05/2002 Medical Director/ General Surgeon, Shoreman Medical Center Ikeja, Nigeria

Provided comprehensive medical care to patients, including diagnosis, treatment, and management of various illnesses and conditions.

Performed physical examinations, ordered diagnostic tests, and interpreted results to formulate accurate diagnoses.

Prescribed medications and treatments based on patient needs and medical guidelines.

Collaborated with interdisciplinary healthcare teams to develop individualized treatment plans for patients.

Conducted regular follow-up visits to monitor patient progress and adjust treatment plans, as necessary.

Educated patients about their medical conditions, treatment options, and preventive measures for optimal health outcomes.

Executed minor surgical procedures, such as suturing wounds or removing skin lesions, lumps, and bumps.

Managed chronic diseases by developing long-term care plans in collaboration with patients and specialists.

Responded promptly to urgent/emergency situations by providing immediate medical intervention.

Participated in continuing education programs to remain updated on the latest advancements in medical practices and technologies.

Adhered strictly to ethical principles while maintaining the confidentiality of patient information.

Coordinated referrals for specialized consultations or additional diagnostic tests when necessary.

Developed strong relationships with patients through effective communication skills.

Demonstrated empathy towards patients' concerns while providing emotional support.

Organized departmental meetings to discuss new research findings or best practices in patient care.

Served as a resource for nursing staff and junior doctors regarding complex cases or medication-related inquiries.

Counseled patients on lifestyle modifications, including diet changes or exercise routines, to improve overall health.

Organized quality improvement initiatives aimed at enhancing patient safety and healthcare outcomes.

Managed a diverse caseload of patients, including pediatric, adult, and geriatric populations.

Spearheaded the expansion of laboratory and radiology departments by building an extension wing.

EDUCATION

Center for Professional Innovation and Education

Certificate, Biostatistics

Remote, USA

01/2005 – 12/2007

Association of Clinical Research Professionals

Certified Clinical Research Coordinator, Clinical Research

Remote, USA

08/1972 – 06/1978

University of Ibadan

Doctor of Medicine, Medicine

Oyo, Nigeria

Skills:

Microsoft Excel

Clinical trials

Medical terminology

Good Clinical Practice

HIPAA

Research

Microsoft Word

Databases

Laboratory experience

Microsoft PowerPoint

FDA regulations

Documentation review

Data collection

Research & development

Epic

EMR systems

Word processing

Clinical development

EKG

Patient monitoring

Vital signs

Clinical research

Data entry

Microsoft Office

SharePoint

Microsoft Access

Phlebotomy

Public health

Recruiting

Microsoft Project

Microsoft Outlook

Project management

Computer skills

Communication skills

Public speaking

Leadership

Mentorship

Team collaboration

Analytical thinking

Scientific Expertise

Oncology

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