Farah Shaikh
San Diego
Summary
Experienced Research Physician with excellent academic background in medicine, nutrition sciences in clinical research and epidemiology 20 plus years of clinical research experience end collaboration in 10 publications
Knowledgeable Clinical Research Associate with several years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
19
19
years of professional experience
Work History
Lead Clinical Research Associate
Fortrea
09.2023 - Current
- Company Overview: Formerly Labcorp
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned
- 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; liaise with vendors; and other duties, as assigned
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Ensure the resources of the Sponsor and organization are 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 travel policy
- Travel, including air travel, may be required and is an essential function of the job
- Undertake feasibility work when requested
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
- Ensure audit readiness at the site level
- Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Formerly Labcorp
Senior Clinical Research Associate
Fortrea
09.2022 - 09.2023
- 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; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the resources of the Sponsor and organization are 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 travel policy
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Independently perform CRF review; query generation and resolution against established data review guidelines on organization or client data management systems as assigned by management
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
- Assist with training, of new employees, eg co-monitoring
- Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
- Travel, including air travel, may be required and is an essential function of the job
- Co-monitoring with junior employees
- Mentoring of junior CRA's
- Presenting pertinent topics of the protocol at the CRA weekly calls
- Assist the Lead CRA's in compiling documents for the team calls
CRA 1
Fortrea
06.2020 - 04.2021
- Performed Site selection (if applicable) initiation, monitoring and close-out visits in accordance with the contracted scope of work and good clinical practices
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report forms (CRF) completion and submission, and data query resolution May have supported start-up phase
- If applicable, may have been accountable for supporting development of project subject recruitment plan on a per site basis
- Worked with sites to adapt, drive and track subject recruitment in line with project needs to enhance predictability
- Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations; escalated quality issues as appropriate
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Built awareness of features and opportunities of study to site and collaborated and liaised with study team members for project execution support as appropriate
Clinical Project Manager
UCSD
San Diego
09.2015 - 06.2020
- Managed the clinical trial of Losartan PTSD, coordinating with six enrolling study sties and collaborated and liaised with study team members for project execution support as appropriate
- Coordinated weekly site meetings and monthly teleconferences for the team
- Trained and assisted research coordinators at the UCSD and non-UCSD enrolling centers, and acted as liaison between patients, physicians and staff members
- Was responsible for updating all regulatory documents as needed for the UCSD IRB system, and working with the Human Research Protection Office
- Initiated submission of quarterly and annual technical reports to the Department of Defense
- Created study brochures and worked with vendors Managed and tracked study supply kits to clinical sites to ensure adequate supply and coordination
- Pre-screened subjects, obtained lists of current medications, registered patients in the UCSD system, sent orders to CTRI, screened and determined if subjects are appropriate for participation, extracted lab data from EPIC, entered all study related data into the REDCap, and sent patient reminders, making sure they had access to a study physician whenever in need
- Created a contact database in Excel and organized data in Dropbox to track/follow and maintain subjects
Clinical Operations Manager
UCSD
San Diego
05.2014 - 09.2015
- Served as the leader and coordinator for implementation of 10 Department of Defense clinical trial activities on Post-Traumatic Disorders and managed the clinical consortium coordinating center (CCCC)
- Was responsible for monitoring and co-monitoring clinical studies and managed the CCCC and service-specific vendors in the initiation, management and completion of clinical studies according to ICH, GCP and CCCCs’ Standard Operating Procedures
- Managed the overall quality of the study data and provided clinical input and managed the study team’s development of the key study documents related to site qualification, initiation, monitoring, closeout visits
- Managed and tracked investigational product supply to clinical sites to ensure adequate supply and coordination; including processing of supply orders from sites
- Coordinated external meetings (eg, Investigator Meetings), conferences and events, as necessary
- Interfaced with representatives from other key functional groups including research and development, and Regulatory affairs
- Trained investigators, site staff, and internal clinical staff on select study processes
In House CRA
UCSD
San Diego
07.2012 - 05.2014
- Was responsible for implementing, managing, and monitoring a complex multicenter clinical trial with ten enrolling clinical trial sites; including responsibility for training, assisting, and monitoring research coordinators at the UCSD and non-UCSD enrolling centers
- Followed-up with sites as needed regarding data anomalies to ensure appropriate resolution
- Performed investigative site electronic data capture review, clinical status tracking, and in-house site management and performance tracking activities to ensure sites’ study activities are conducted in adherence with the Master Study Protocol, CC Standard Operating Procedures (SOPs), ICH-GCP, and all applicable regulatory requirements
- Was responsible for reviewing data collection instruments for accuracy and completeness and Identified problems in protocol implementation at sites and resolved them
- Coordinated external meetings (e.g, Investigator Meetings), conferences and events, as necessary
- Traveled 35%-40% of the time to conduct onsite clinical monitoring of investigative sites nationwide
Clinical Research Project Manager
UCSD
San Diego
07.2008 - 07.2012
- Was responsible for coordination, project management and data collection on NIH funded study on the role of obesity on vascular inflammation and immune cell activation in participants with elevated blood pressures
- Tasks includes: recruitment of participants, consenting participants, developing and implementing study protocols, conducting body measurements (height, weight, waist and hip) exercise testing, and getting DEXA scans done on the participants
- Served as the primary liaison with university staff and provided work direction to student interns (as needed) involved in qualifying study subjects for participation, registering study participants, scheduling, and successful completion of the subject for the study
- Was responsible for monitoring and quality assurance procedures, overseeing the quality of clinical and research data, and working on the monthly presentations for the Principal Investigator
- Worked with the IRB to ensuring subject safety, monitored adverse events, and updated annual consents, implementing the project as needed along with the PI and was responsible for updating all regulatory documents as needed for the UCSD IRB system
- Organized data in the study-trax system, tracked participants, and extracted data into Excel/SPSS for analysis
Clinical Research Coordinator
UCSD
San Diego
09.2006 - 07.2012
- Established and maintained relationships with outside agencies to recruit subjects into clinical research studies and Created promotional materials including flyers, brochures and correspondence for public distribution
- Reviewed and processed psychological questionnaires collected from subjects, and Identified potential recruitment sources
- Screened and enrolled patients
- Was responsible for data collection, interpretation, and management of the data set in the CREDIT system, and for updating of all regulatory documents as needed for the UCSD IRB system, working with the sponsor
Education
Doctorate of Philosophy - Public Health
University of Texas
Houston, Texas, United States of AmericaMasters of Public Health - Public Health
University of Texas
Houston, Texas, United States of AmericaDoctor of Medicine - Medicine
Dow Medical College
Karachi, Sindh, PakistanOther -
Educational Commission for Foreign Medical Graduates
Skills
- Clinical Operations
- Project Initiation
- Study Close-Out
- Regulatory Understanding
- GCP
- ICH guidelines
- Regulatory submission
- Scientific committee
- Ethics committee
- Cross functional teams
- Written communication
- Verbal communication
- Team building
- Work ethic
- Enthusiastic team player
Language Capabilities
- English, Full Professional Proficiency
- Urdu, Full Professional Proficiency
- Hindi, Full Professional Proficiency
Publications
- Sex-specific roles of cellular inflammation and cardiometabolism in obesity-associated depressive symptomatology, Jordan N Kohn, Yesenia Cabrera, Stoyan Dimitrov, Nicholas Guay-Ross, Christopher Pruitt, Farah D Shaikh, Suzi Hong
- Benefit of physical fitness against inflammation in obesity: role of beta adrenergic receptors., Hong S, Dimitrov S, Pruitt C, Shaikh F, Beg N, Brain Behav Immun., 07/01/14, 39, 113-20, 10.1016/j.bbi.2013.12.009, 24355098
- Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies., Dimsdale JE, Ball ED, Carrier E, Wallace M, Holman P, Mulroney C, Shaikh F, Natarajan L, Support Care Cancer., 12/01/11, 19, 12, 2015-20, 10.1007/s00520-010-1052-1, 21116652
- Differential TNF production by monocyte subsets under physical stress: blunted mobilization of proinflammatory monocytes in prehypertensive individuals., Dimitrov S, Shaikh F, Pruitt C, Green M, Wilson K, Beg N, Hong S, Brain Behav Immun., 01/01/13, 27, 1, 101-8, 10.1016/j.bbi.2012.10.003, 23046723
- Knowledge and attitudes of Pakistani medical students towards HIV-positive and/or AIDS patients., Shaikh FD, Khan SA, Ross MW, Grimes RM, Psychol Health Med., 01/01/07, 12, 1, 7-17, 10.1080/13548500500477667, 17129929
- Beta-adrenergic receptor mediated inflammation control by monocytes is associated with blood pressure and risk factors for cardiovascular disease., Hong S, Dimitrov S, Cheng T, Redwine L, Pruitt C, Mills PJ, Ziegler MG, Green JM, Shaikh F, Wilson K, Brain Behav Immun., 11/01/15, 50, 31-38, 10.1016/j.bbi.2015.08.012, 26300225
References
Available Upon Request
Therapeutic Experience
- Psychiatry, Mental & Behavioral Disorders Post-Traumatic Stress Disorder, Phase IIb
- Neurology, Dementia Alzheimer's Disease, Phase III
- Pulmonary/Respiratory, Chronic Respiratory Disorders Moderate/Severe Asthma, Phase III
- Ophthalmology, General Ophthalmology, Phase III
- Cardiovascular, Hypertensive and Hypotensive Diseases Hypertension, Phase IIa
Summary Of Experience
Experienced Research Physician with excellent academic background in medicine, nutrition sciences in clinical research and epidemiology. 20 plus years of clinical research experience and collaboration in 10 publications.
Timeline
Lead Clinical Research Associate
Fortrea
09.2023 - Current
Senior Clinical Research Associate
Fortrea
09.2022 - 09.2023
CRA 1
Fortrea
06.2020 - 04.2021
Clinical Project Manager
UCSD
09.2015 - 06.2020
Clinical Operations Manager
UCSD
05.2014 - 09.2015
In House CRA
UCSD
07.2012 - 05.2014
Clinical Research Project Manager
UCSD
07.2008 - 07.2012
Clinical Research Coordinator
UCSD
09.2006 - 07.2012
Doctorate of Philosophy - Public Health
University of Texas
Masters of Public Health - Public Health
University of Texas
Doctor of Medicine - Medicine
Dow Medical College
Other -
Educational Commission for Foreign Medical Graduates