Martha Felder, CCRP
Regulatory Specialist at Accel Research Sites- Claim this Profile
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Bio
Korin C.
I have had the pleasure of being both a co-worker and a friend to Martha Felder for six years. In and out of the office, Ann conducts herself with honesty and integrity. Martha is well- organized and extremely knowledgeable in the field of clinical research. She has excellent understanding of Good Clinical Practices, and can be counted on not just to work hard, but to represent whatever company she works for in a positive light. Martha has displayed her attention to detail by seamlessly organizing numerous studies from inception to completion. She has worked directly with other ancillary departments to help figure out study logistics, as well as worked closely with the DSMB and the IRB. I know of numerous occasions where patients and other team members mentioned how much they enjoy working with Martha. For these reasons, I have no hesitation in recommending Martha to your company.
Korin C.
I have had the pleasure of being both a co-worker and a friend to Martha Felder for six years. In and out of the office, Ann conducts herself with honesty and integrity. Martha is well- organized and extremely knowledgeable in the field of clinical research. She has excellent understanding of Good Clinical Practices, and can be counted on not just to work hard, but to represent whatever company she works for in a positive light. Martha has displayed her attention to detail by seamlessly organizing numerous studies from inception to completion. She has worked directly with other ancillary departments to help figure out study logistics, as well as worked closely with the DSMB and the IRB. I know of numerous occasions where patients and other team members mentioned how much they enjoy working with Martha. For these reasons, I have no hesitation in recommending Martha to your company.
Korin C.
I have had the pleasure of being both a co-worker and a friend to Martha Felder for six years. In and out of the office, Ann conducts herself with honesty and integrity. Martha is well- organized and extremely knowledgeable in the field of clinical research. She has excellent understanding of Good Clinical Practices, and can be counted on not just to work hard, but to represent whatever company she works for in a positive light. Martha has displayed her attention to detail by seamlessly organizing numerous studies from inception to completion. She has worked directly with other ancillary departments to help figure out study logistics, as well as worked closely with the DSMB and the IRB. I know of numerous occasions where patients and other team members mentioned how much they enjoy working with Martha. For these reasons, I have no hesitation in recommending Martha to your company.
Korin C.
I have had the pleasure of being both a co-worker and a friend to Martha Felder for six years. In and out of the office, Ann conducts herself with honesty and integrity. Martha is well- organized and extremely knowledgeable in the field of clinical research. She has excellent understanding of Good Clinical Practices, and can be counted on not just to work hard, but to represent whatever company she works for in a positive light. Martha has displayed her attention to detail by seamlessly organizing numerous studies from inception to completion. She has worked directly with other ancillary departments to help figure out study logistics, as well as worked closely with the DSMB and the IRB. I know of numerous occasions where patients and other team members mentioned how much they enjoy working with Martha. For these reasons, I have no hesitation in recommending Martha to your company.
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Experience
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Accel Research Sites
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Specialist
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Aug 2021 - Present
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Care Access Research
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Wellness and Fitness Services
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Clinical Trial Specialist
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Dec 2020 - Apr 2022
Covid Trials Covid Trials
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PANDA Neurology & Atlanta Headache Specialist
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United States
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Medical Practices
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1 - 100 Employee
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CRA
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Nov 2015 - Dec 2020
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ThreeWire, Inc.
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Accounting
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Data Manager
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Nov 2019 - 2020
Contract (PRN) Contract (PRN)
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Clinical Research Atlanta
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United States
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Research Services
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1 - 100 Employee
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Clinical Research Associate I
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Sep 2014 - Nov 2015
Assist with writing protocols, case report forms, consent forms and ensures good clinical practices are followed. Collection of regulatory documents, creation of the Trial Master File (TMF). Setting up study contracts and budgets. Reviews Regulatory Documents at Investigator sites. Overall drug accountability for study drug and supplies.Review of patient charts and clinical data Review discrepancies within entered data, and make appropriate corrections or request clarification as needed. Review of IND safety reports submitted to IRB and filed into Regulatory binder.Track AE’s /SAE’s at Investigator site. Verify CRF’s with source documentation.Responsible for Adherence to protocol at sites Monitor and QA all subject charts for query resolutions.Documentation for audits trails, Follow all ICH and FDA Guidelines Site selection, Initiation ,close-out, and Interim Monitoring. Ensure that informed consents were signed properly by subjects with proper version Show less
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Children's Healthcare of Atlanta
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United States
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Hospitals and Health Care
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200 - 300 Employee
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Clinical Research Coordinator
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Oct 2008 - Sep 2014
Managed all regulatory documents related to clinical research activities and study site management. Completed, IRB preparation, submission, reporting and termination documents. Lead all monitoring and site study meetings. Served as liaison between site and Sponsor. Lead weekly telecoms to ensure communication of key issues and followed up on action plans Coordinated and performed in-services for clinical department on new and upcoming clinical trials. Trained CRC's, nurses, and med techs on clinical trials processes and protocol guidelines. Independently manages significant and key aspects of multiple studies simultaneously and coordinated studies from inception to completion. TMF(Trial Master Files), Internal Audits Show less
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Research Manager
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Jan 2004 - Oct 2008
Office Manager, General Administrative duties making sure front and back office was properly ran. Interview and train all new Medical Assistants as needed. Worked closely with Providers in all areas of the office.Lead Clinical Research, started all Clinical Trials that were implemented. Study start up documentation, Contract agreements, Regulatory documents, 1572 forms, GCP’S, AE, SAE Drug Accountability, remote data capture, investigators meetings, work directly with patients, and all other duties. Also planned and arranged community health fair for the physician’s office. Show less
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Education
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University of Arizona
3.84 -
Westwood College-Northlake
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General -
Lincoln College of Technology-Marietta
Associate of Arts and Sciences (A.A.S.), Medical/Health Management and Clinical Assistant/Specialist