Clinical Research Associate

Tim Banjoh

ad8q24@r.postjobfree.com 281*-***-****

Houston,TX

1O B J E C T I V E

Experienced Senior Clinical Research Associate (CRA) in study phases I, II, and III that encompasses working as a CRA for 7 years. Experienced and detail-oriented professional in the performance of clinical trial operations.

SKILLS & ABILITIES

• 6-plus years’ experience in the research industry with onsite monitoring activities, in Oncology, CNS, Pulmonary Diseases, Rare Diseases, Infectious diseases and Medical Device.

• Thorough knowledge of clinical development processes and conduct of clinical studies.

• Awareness of global regulatory and pharmacovigilance environments.

• Experience in site management from phase I -III

• Excellent working knowledge of GCP/ICH guidelines and FDA regulations.

• Excellent communication and written skills.

• Strong working knowledge of medical/scientific terminologies.

• Experience working with EDC (AGMednet, iMednet Rave and inform) and CTMS (SimpleTrials, IMPACT and Medidata Rave) systems.

• Excellent ability to effectively communicate with physicians, study coordinators and other site staffs.

• Excellent collaboration with team members and constantly striving for teamwork

• Innate passion to drive for results and keeping customer focus as the forefront

• Proficient in Microsoft office.

• Excellent interpersonal skills.

THERAPEUTIC EXPERTISE

§ CNS: ADHD

§ ONCOLOGY: Lung Cancer (NSCLC), Breast Cancer, Solid Tumor, Leukemia, Glioblastoma Multiforme (GBM), Myelodysplastic Syndromes (MDS), Ovarian Cancer, Lymphoma.

§ INFECTIOUS DISEASES: Flu, Meningitis, HIV

§ RARE DISEASE: Multiple sclerosis, CIDP

§ PULMONARY DISEASE: COPD

§ MEDICAL DEVICE: Heart Failure, Cardiac Rhythm Management, Structural Heart, Peripheral Intervention.

Tim Banjoh

ad8q24@r.postjobfree.com 281*-***-****

Houston,TX

E X P E R I E N C E S

ICON/DOCS Global – Detroit, MI

Sr. Clinical Research Associate Aug 2020 – April 2024

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines

• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements

• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations

• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan

• Monitors with knowledge of quality/scope/timeline and budget parameters

• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates

• Maintains project tracking system of subjects and site information, as applicable

• Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts

• Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager

• Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients

• Reviews IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan

• Completes all required internal training (general and study-specific) on-time

• Acts as a resource for other CRAs and shares knowledge base and best practices Abbott (St. Jude Medical) – Detroit, MI

Sr. Clinical Research Associate Nov 2018 – Aug 2020

• Routinely assured compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.

• Critically evaluated adequacy of investigator sites (qualifications, facilities, equipment and performance). Successfully plans and conducts study initiation visits for investigator sites.

• 100 percent completion and submission of monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work. Also, routinely maintains awareness of key study performance indicators for delegated sits. Supports subject recruitment and retention strategies.

• Ensured all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools.

• Verified that the process of obtaining informed consent has been adequately performed and documented for each subject.

Tim.banjoh@Tim gmail.Banjoh com 281-***-****

Houston, TX

• Maintained site performance metrics and implements action plans for sites not meeting expectations with minimal guidance.

• Maintained current regulatory documentation for assigned sites according to Essential Regulatory Document Guidelines and/or regulatory project plan.

• Maintained all areas of cover as assigned (site & study level) to audit readiness standards and supports preparation for audit and required follow up actions.

• Routinely demonstrated sufficient time management to achieve assigned required deliverables: consistent on time expense reports, timecard submissions, trip report submissions/finalization, monitoring visits frequency as per Statement of Work (SoW), Clinical Monitoring Plan (CMP). Follows standard process for documentation of site contacts (visits, phone, email etc.).

• Performed IP inventory, reconciliation, storage and security. Experience in verifying that the IP has been dispensed and administered to subjects according to the protocol.

• Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with that of the trial master file (TMF).

• Maintained effective, accurate, and timely communication with the site staff and project team. Top notch participation in global conference calls and meetings to review progress of ongoing clinical trials.

• Provided training or mentorship to more junior-level CRAs while also performing training and sign off visits for junior CRA staff, as assigned. PRA Health Sciences – Southfield, MI

Clinical Research Associate II Jan 2017 – Nov 2018

• Very experienced in the application of tumor response criteria such as immune-related response criteria (irRC), RECIST 1.1, iRECIST, mRANO, RANO, and RECIL.

• Completed Site Selection, Site Initiation and Routine Monitoring Visits according to SOPs

• Maintained close relationship with clinical investigators to improve protocol compliance, improved serious adverse event reporting, met timelines by closely working with clinical sites

• Improved critical clinical data flow through extra-mandated delegation between clinic and data management crew

• Responsible for performing study activities regarding the implementation and monitoring of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs.

• Monitored recruitment and data quality while onsite and remotely through EDC systems/communication with sites.

• Performed onsite drug (IP) accountability and reconciliation and verified drug storage met protocol and SOP requirements.

• Performed continuous reviews of Investigator’s Trial File to assure quality of the documentation files, completion and compliance with company SOPs, GCP and ICH Guidelines while on site.

• Responsible to ensure that the mandatory trial entries were made in all requisite study systems including clinical trial management systems, IVRS, TMF, etc.

• Collaborated with other members within Clinical Trial Management (CTM) and with various vendor team members to ensure synergy and coordinated response to study issues. Tim.banjoh@Tim gmail.Banjoh com 281-***-****

Houston, TX

PRA Health Sciences – Southfield, MI

Clinical Research Associate I Aug 2015 – Jan 2017

• Completed Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to SOPs

• Maintained close relationship with clinical investigators to improve protocol compliance, improved serious adverse event reporting, met timelines by closely working with clinical sites

• Improved critical clinical data flow through extra-mandated delegation between clinic and data management crew

• Monitored recruitment and data quality while on site and remotely through EDC systems/communication with sites.

• Performed on-site drug (IP) accountability and reconciliation and verified drug storage met protocol and SOP requirements.

• Responsible to ensure that the mandatory trial entries were made in all requisite study systems including clinical trial management systems, IVRS, TMF, etc.

• Performed source document verification, retrieved case report forms (CRFs) and performed query resolution in a timely manner

• Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviewed SAE information, resolved queries and assisted sites in completion of SAE reports.

• Prepared, collaborated and implemented Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA

E D U C A T I O N

University of Manchester, United Kingdom

BS. Chemical Engineering

ICH GCP Certification

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