Lolita Kelley
Damascus
Summary
Dynamic Clinical Operations Manager with extensive experience at Fortrea, driving project excellence and compliance. Proven track record in staff development and performance management, leveraging strong leadership and problem-solving skills. Expert in clinical trial management systems, optimizing processes to enhance efficiency and ensure data integrity across global operations.
Overview
24
24
years of professional experience
3
3
Certification
Work History
Manager, Clinical Operations
Fortrea (Formerly Labcorp)
Durham
06.2016 - Current
- Ensure staff accountability for project quality, compliance, and adherence to contractual obligations.
- Promote standardized processes and tools aligned with organizational policies to drive efficiency and productivity.
- Contribute to the development and refinement of SOPs, standard plans, and templates.
- Oversee the onboarding of new direct reports, ensuring completion of GCP training prior to study involvement.
- Enforce timely issue escalation to management, sponsors, and QA, and assess regional impact for corrective actions.
- Coach staff on effective investigator engagement and oversight practices.
- Monitor weekly billable hours and utilization; identify and escalate variances, supporting mitigation strategies.
- Support recruitment efforts through candidate screening and interviewing.
- Manage direct report expenses, approve reports, and ensure compliance with travel policies.
- Oversee time management, PTO/FTO tracking, and conduct performance and salary reviews.
- Lead performance management initiatives, including implementation of Focused Coaching and Performance Improvement Plans to support staff development and accountability.
- Clinical Operations Leadership at Fortrea
- Driving excellence across global clinical operations through strategic initiatives and cross-functional collaboration. Key contributions include:
- Mentorship in Oncology Monitoring Excellence (OMEA) and leadership in Virtual Assessment Visit (VAV) and Clinical Quality Control (CQC) compliance.
- Active role in Trial Master File (TMF) optimization and Trip Report Compliance KQI workgroups.
- Oversight of multi-sponsor portfolio management and advancement of Xcellerate product initiatives (RAPID Anywhere, RIM 2.0, Start My Day, Risk Evaluation, AI/ML RDS, CRA Dashboards).
- Led pilot and enhancement of Monitoring Dashboards and contributed to global onboarding and ongoing training programs.
- Designed and delivered onboarding curriculum, Focused Coaching tools, RECIST 1.1 training, and Brain Booster CRA competency modules.
- Developed centralized analyst roles and supported IHCRA/CA task alignment.
- Facilitated weekly North America Line Manager meetings and provided continuous mentoring, dashboard navigation, and problem-solving support.
- Managed ~20 direct reports, overseeing performance, coaching, and development.
- Collaborated on global CAPA workstreams to enhance monitoring surveillance, onboarding, and training governance.
- Chair of Fortrea Clinical Network Monitoring Excellence Ongoing Training Governance.
Senior Clinical Research Associate II
Fortrea (Formerly Labcorp)
05.2018 - 10.2020
- Previously responsible for all aspects of study site monitoring including routine monitoring and close- out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaised with vendors and other duties, as assigned
- Previously responsible for all aspects of site management as prescribed in the project plans
- Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements
- Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Monitored data for missing or implausible data and Ensured audit readiness at the site level
- Travel, including air travel, may have been required and was an essential function of the job
- Prepared accurate and timely trip reports
- Served as lead monitor for a protocol or project and may have assisted in establishing monitoring plans and trip report review as assigned
Senior Clinical Research Associate I
Fortrea (Formerly Labcorp)
06.2016 - 04.2018
- Previously responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaised with vendors and other duties, as assigned
- Previously responsible for all aspects of site management as prescribed in the project plans
- Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements
- Ensured the integrity of the data submitted on CRFs or other data collection tools by careful source document review
- Assisted with training, mentoring and development of new employees, e.g. co-monitoring
- Ensured the resources of the sponsor and Fortrea were spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
- Ensured audit readiness at the site level
- Prepared accurate and timely trip reports
- Travel, including air travel, may have been required and was an essential function of the job
Clinical Research Associate
Westat
Rockville
05.2012 - 06.2016
- Conducted international and domestic site qualification, initiation, interim, close-out, and training visits.
- Participated in the protocol development process, protocol management, orientation and training of new and international CRAs and acting as a resource for other project staff regarding protocol-related questions
- Assessed the accuracy of protocol implementation, AE/SAE event reporting, adherence to Good Clinical Practice (GCP) guidelines and the validation of reported data
- Assessed site compliance with regulatory requirements and ensured the collection, review and updating of all essential documents of the trial master files as defined by FDA regulations, sponsor, company SOPs and general industry standards
- Tracked protocol enrollment at the site level, identified and investigated enrollment issues and provided training and feedback on site performance including recommendations for improvement
- Served as a liaison with clinical centers, project operations, sponsors and other stakeholders in the protocol development and clinical monitoring process
- Ensured compliance with company, sponsor and Federal regulations
Senior Research Program Coordinator II, Division of Rheumatology
John Hopkins University School of Medicine
Baltimore
10.2010 - 05.2012
- Previously responsible for monitoring the clinical course and collection of research data
- Managed patient information database and source documentation
- Previously responsible for patient recruitment, consent, screening, verification of eligibility, administration and distribution of study drug and placebo, monitoring of vitals, phlebotomy, EKG and coordination of study visits
- Reported and updated all AEs and SAEs to sponsors
- Monitored compliance with the quality assurance and quality control goals of studies
- Maintained the integrity of all clinical trials by adhering to HIPAA regulations, FDA, ICH, JHU and GCP guidelines
Senior Clinical Research Coordinator
Center for Rheumatology & Bone Research
Wheaton
03.2007 - 10.2010
- Previously responsible for all data management including completion of CRFs, data clarification via queries, source document design and document preparation for monitoring, supervision of research study staff and taking research meeting minutes
- Interacted with internal and external review agencies including the preparation and submission of regulatory documents for the IRB and sponsor
- Managed patient information database and source documentation; reported and updated all AEs and SAEs to sponsors
- Previously responsible for study advertisement, patient recruitment, consenting of patients, patient education and the completion of CRFs, SAEs and queries
- Previously responsible for patient recruitment, consent and coordination of visits, administration and distribution of study drug and placebo, monitoring of vitals, phlebotomy, EKG, drug mixing for infusions and SQ injections and all other protocol procedures
- Coordinated and conducted patient visits including phlebotomy, EKG, OBPM/ABPM, study drug administration and administered questionnaires
- Participated and coordinated site initiation monitoring and study close out visits
- Managed patient information, source docs and IND Safety Reports and performed all other necessary duties related to clinical trial management
- Completed protocol review, created and updated SOPs and regulatory compliance
- Maintained the integrity of all clinical trials by adhering to HIPAA regulations and FDA, ICH and GCP guidelines
Contractor, Clinical Research Coordinator (part-time)
Sislen & Associates – Gilbert Eisner, MD
Washington
03.2007 - 07.2007
- Previously responsible for all data management including completion of CRFs, data clarification via queries, source document design and document preparation for monitoring, supervision of research study staff and taking research meeting minutes
- Interacted with internal and external review agencies including the preparation and submission of regulatory documents for the IRB and sponsor
- Managed patient information database and source documentation; reported and updated all AEs and SAEs to sponsors, study advertisement, patient recruitment, consenting of patients, patient education and the completion of CRFs, SAEs and queries
- Previously responsible for patient recruitment, consent and coordination of visits, administration and distribution of study drug and placebo, monitoring of vitals, phlebotomy, EKG, drug mixing for infusions and SQ injections and all other protocol procedures
- Coordinated and conducted patient visits including phlebotomy, EKG, OBPM/ABPM, study drug administration and administered questionnaires
- Participated and coordinated site initiation monitoring and study close out visits
- Managed patient information, source docs and IND Safety Reports and performed all other necessary duties related to clinical trial management
- Completed protocol review, created and updated SOPs and regulatory compliance
- Maintained the integrity of all clinical trials by adhering to HIPAA regulations and FDA, ICH and GCP guidelines
Education
Bachelor of Science (BS) - Biology
Virginia Union University
Richmond, VA, USAGraduate Certificate - Epidemiology
George Washington University School of Public, Health And Health Services
Washington, DCGraduate Certificate - Science of Clinical Investigation
Johns Hopkins Bloomberg, School of Public Health
Baltimore, MDSkills
- Clinical trial management systems
- Data management platforms
- Electronic data capture
- IVRS and IRT solutions
- Regulatory compliance tools
- Document management systems
- Patient engagement software
- Clinical trial management
- Good Clinical Practice
- Standard Operating Procedures
- Site monitoring
- Data integrity verification
- Regulatory compliance
- Project oversight
- Cross-functional collaboration
- Resource allocation
- Staff training
- Effective communication
- Problem solving
- Performance management
- Team leadership
- Continuous improvement
- Conflict resolution
- Policy and procedure development
- Product management
- Complex Problem-solving
- Skype
- Staff training and development
- Networking strategies
- Relationship building
- Customer service
- Expectation setting
- Trend analysis
- Expense tracking
- Verbal and written communication
- Risk management
- Staff development
- Key performance indicators
- Stakeholder management
- Policy implementation
- Operations management
- Change management
- Staff management
- Documentation and reporting
- Safety procedures
- Partnership development
- Work prioritization
- Project management
- Performance evaluations
- Vendor management
- Cross-functional teamwork
- Goal setting
- Time management
- Employee onboarding
- Data analysis
- Recruiting and interviewing
- Innovation management
- Coaching and mentoring
- Task delegation
Certification
Certified Clinical Research Coordinator (ACRP)
Awards
NIH Postbaccalaureate Intramural Research Training Award (IRTA), National Institute of Health (NIH), 2002
Affiliations
NIH Postbaccalaureate Intramural Research Training Award (IRTA) Fellowship, National Institute of Health (NIH), 2003
Training
- Training
- ICH GCP E6(R3), Fortrea, 2025
Therapeutic Experience
- Immune Mediated Inflammatory Disease (IMID): Systemic IMID – Rheumatoid Arthritis (Phase I, II, III), Gout (Phase II, III), Fibromyalgia (Phase I, II), Osteoarthritis (Phase II, III, IV), Lupus (Phase I, II, III), Ankylosing Spondylitis (Phase II, III), Psoriatic Arthritis (Phase II, III), Other – Sjogren’s Syndrome (Phase II, III); Inflammatory Bowel – Ulcerative Colitis (Phase II); Inflammatory Respiratory – Asthma (Phase II, III), COPD (Phase II, III); Allergy – Uticaria (Phase II, III), Other – Angioedema, Seasonal Allergies (Phase II, III)
- CardioMetabolic: Metabolic and Cardiovascular Risk – Pulmonary Arterial Hypertension (PAH) (Phase II, III), Cardiovascular Outcomes Studies (Phase IV)
- NeuroScience: Neurology – Alzheimer’s (Phase I, II); Psychiatry – Post-Traumatic Stress Disorder (PTSD) (Phase I, II)
- Infectious Disease: Fungus and Parasitic Disease Therapy – Other – Respiratory Syncytial Virus (RSV) (Phase I, II); Anti-Viral Therapy – Hepatitis C (Phase II), HIV/AIDS (Phase I, II, III, IV); Vaccines for bacterial or viral disease prevention – Pediatric Respiratory Syncytial Virus (RSV) (Phase I, II, III)
- Oncology: Solid Tumors – Breast Cancer (Phase II, III), Gastro-intestinal Tumors – Colorectal (Phase II), Gastro-intestinal Tumors – Gastro-Esophageal Cancer (Phase II), Gastro-intestinal Tumors – Pancreatic Cancer (Phase II), Genito-Urinary Tumors – Renal Cell Carcinoma (Phase I), Genito-Urinary Tumors – Bladder Cancer (Superficial) (Phase I), Genito-Urinary Tumors – Prostate Cancer (Phase II), Gynecological Tumors – Cervical Cancer (Phase II), Head and Neck – Squamous Cell Ca (Phase II), Head & Neck – Nasopharyngeal (Phase I), Melanoma (Loco-regional) (Phase I), Thoracic Tumors – Small Cell Lung Cancer (Phase I), Thoracic Tumors -Non-Small Cell Lung Cancer (Phase I, II, III); Hematologic Malignancies – Leukemia (ALL) (Phase I), Leukemia (CLL) (Phase I, II), Leukemia (CML) (Phase I), Hodgkins Lymphoma (Phase I), non-Hodgkins Lymphoma (Phase I, II, III), Myelodysplasia (Phase II), Multiple Myeloma (Phase I), Other hematologic malignancies – Myeloproliferative Disorders Myelodysplastic Syndrome (Phase I), Matel Cell Lymphoma (Phase III); Cancer supportive care – Anemia due to chemo (Phase II)
- Other: Non-Inflammatory Immunology – Transplantation (Phase I, II); Hematology – Other hematology; Musculoskeletal – Osteoporosis (Phase II, III)
- Special Patient Population: Pediatric, Adolescent
- Oncology (Type of Treatment): CAR-T
Timeline
Senior Clinical Research Associate II
Fortrea (Formerly Labcorp)
05.2018 - 10.2020
Manager, Clinical Operations
Fortrea (Formerly Labcorp)
06.2016 - Current
Senior Clinical Research Associate I
Fortrea (Formerly Labcorp)
06.2016 - 04.2018
Clinical Research Associate
Westat
05.2012 - 06.2016
Senior Research Program Coordinator II, Division of Rheumatology
John Hopkins University School of Medicine
10.2010 - 05.2012
Senior Clinical Research Coordinator
Center for Rheumatology & Bone Research
03.2007 - 10.2010
Contractor, Clinical Research Coordinator (part-time)
Sislen & Associates – Gilbert Eisner, MD
03.2007 - 07.2007
Bachelor of Science (BS) - Biology
Virginia Union University
Graduate Certificate - Epidemiology
George Washington University School of Public, Health And Health Services
Graduate Certificate - Science of Clinical Investigation
Johns Hopkins Bloomberg, School of Public Health
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