Shamsun Nahar

**** *** ***

Fairfax, VA 220**-***-*** 4381 adbpol@r.postjobfree.com

https://www.linkedin.com/in/shamsun-nahar-82a193145/

Research Coordinator experience over various multi-therapeutic areas, 4+ years’ experience in a Pharmaceutical Research Environment as a clinical research coordinator, M.D from Shaheed Ziaur Rahman Medical College/ Bogra, Bangladesh.

Knowledgeable about: Well-versed in TMF Maintenance, accurate documentation, data entry, electronic health records (EHR). Regularly provide clinical support, Conducting CRA visits and ensuring source matches EDC and clearing queries in a timely fashion. Inspection readiness and Good Source documentation. Experienced on CTMS system, Job duties & protocols of Clinical Research, OSHA rules & regulations, Institutional Review Board (IRB), Trial Master File (TMF), Investigator Site File (ISF), Case Report Forms (CRF), all other procedures appointed to Clinical Research Professional.

Updating Trial Master File (TMF) Electronic Document Management Updating SOP’s and Protocols

GCP/ ALCOA Reporting AE/SAE Finance Reporting

Site Initiation and Close Visits Inventory Product Maintenance TMF Reference Model

EMR - Documentation Internal Monitoring Protocol HIPAA Compliance

Certifications: IATA, NIH Stroke Scale, Columbia- Suicide Severity Rating Scale (CSSRS), NIH Protocols, ICH/GCP; Certified CPR.

Technology: MS Office (Word, Excel, PowerPoint, Access), Electronic Medical Records (EMR).

Clinical Trial Management System (CTMS): Allegro, Real Time.

Multilingual: English, Bengali, Urdu & Hindi.

Professional Healthcare Experience

Research Coordinator, George Washington Medical Faculty Associates, Washington DC.

Dec 2018 – Dec 2019

Recruit, screen and enroll eligible subjects for participation in research protocols with final authorization from principal investigator and/or research team leader

As a principal investigator designee, explain the protocol in detail and obtain informed consent from potential subjects

Verify patient eligibility for studies with principal investigator and/or research team leader

Obtain medical release of information from patient as needed per protocol

Coordinate and document all aspects of subjects’ participation (including subject interviews, telephone contact with subject or friends/family of the patient; conversations with the research team and all medical providers who participate in the patients care, etc.) to ensure a comprehensive and consistent approach to the subject management on protocol and Collaborates in the development of recruitment strategies to ensure patient accrual within protocol time frames

Ensures collection of pertinent data from internal and external sources and monitors compliance with requirements of the clinical studies

Monitor clinical course of subject’s enrolled in clinical trials, under nursing supervision, ensuring that research protocol is executed appropriately

Participates in internal audits and assures compliance with outside monitoring

Maintain and complete protocol specific patient records and Case Report Forms (CRF).

Maintain a good working knowledge of all assigned protocols

Maintain confidential records of required source documentation on each assigned research subject on protocol

Meet regularly with principal investigators, research manager and protocol team leaders to review patient participation, data accuracy and overall project progress and Provide updates on current progress of the study as requested

Maintain patient study calendars and Schedule patient study appointments

Serve as backup for research protocols (other than primary assignment) as needed.

Assist with preparation of grant applications, presentations and manuscripts. Assist budget analyst in maintaining accurate accounting of study costs, revenues, and financial projections.

Develop research instruments (protocol specific source documentation, lab forms, and template notes) necessary for study execution

Control quality of source documentation and research integrity also detect and help solve logistical, technical and patient related problems as they pertain to protocol participation

Coordinate laboratory specimen processing and handling with appropriate lab supervisors.

Act as liaison between the study and other departments as necessary for protocol implementation

All IRB related updates and submission on timely manner to Institutional Review Board, Submit all IND’s to the IRB and complete all continue review on time. Submit all protocol related deviation to the IRB and entering e–irb protocols and updates also interacting with IRB staff.

Attend study meetings to represent the research unit and grow in knowledge of data quality and the federal regulations governing clinical research

Primary Research Coordinator, Touchstone Clinical Research; Rosedale, NY

Feb 2015 – Nov 2018

Ensure protocol, GCP, & regulatory compliance and assist in the planning, implementation, managing, and reporting of Phase I-IV clinical studies

Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)

Consult with PI, Sub-I and other study supervisor as well as performs literature search and data analysis to address research questions.

Act as a liaison for various studies with drug companies, study monitors, patients and their primary care providers; assist various monitors during study monitor visits and audits.

In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)

Maintaining accurate data entry in database, cleaning, review of study results, and interpretation of results

Adhering to key performance indicators for clinical study development, conduct, and reporting

Presents concepts, facts, and reports and advises on key trends and issues

Monitor and assess clinical supplies, troubleshooting routine site inquiries.

Work in multiple therapeutic area and is completed under limited supervision

Supports the planning, execution and reporting of clinical programs/trials. Individual contributor with specialized knowledge

Handle multiple protocols simultaneously. Manage all the clinical trials project at multiple site.

Perform basic clinical evaluation and Contributes to risk resolution by escalating and monitoring project risks

Updating Regulatory documents and Regulatory submissions. (submission of 1572 and FDA form, protocol Signature Pages) and update it to the Trial Master Files as needed.

Carefully collect, compile and document clinical research data according to the study protocol and sponsor guidelines. Maintain documentation according to protocols, standard operating procedures, and FDA requirements.

Perform administrative tasks for the clinical research department including filing, appointment scheduling, phone follow ups, mailings, supply inventory, investigational product inventory. etc.

Work with Local or Central IRB as needed for approval for changes in ad Campaigns and Informed Consents etc.

During Monitoring Visit verify the rights & well-being of subjects are protected and data is accurate, complete & verifiable.

Screen patients to identify eligible study candidates through chart review, patient interviews, discussions with practice doctors, and other methods. Facilitate enrollment of eligible patients by working closely with physicians and staff. Explain studies to eligible candidates, answer questions, and obtaining written consent as delegated by the study PI.

Contact IVR or IXRS system to screen, screen fail and randomize the subject. Complete and upload visit to dispense subjects Medications. Upload subject’s status/visit tracking. Update and notify new drug shipment and supply management.

Monitors and assesses clinical supply.

Very realistic as well as economical to maintain the supply received from sponsor. Avoided unnecessary west of clinical supply. Very inclusive on paperwork. Always review the data and make adjustment as appropriate. Order Supply’s as timely fashion when it needed.

Train and mentor new staff on protocols, educate and train new research interns and medical assistants on clinical trials and procedures involved.

Arrange weekly meetings for PI and Site manager to conduct overall assessment of study procedures and update and educate staff on new protocols.

Perform basic clinical evaluations: including blood pressure, pulse, performing EKGs, phlebotomy, review current and changes to medications, document adverse events.

Working with different Investigator initiated protocols.

Working as a Regulatory submission personal. Complete and submit Contracts, proposal new budget and negotiate budget.

Work in multiple therapeutic areas as a CRC and make subject comfortable with medical explanation, terminology and research trials.

Perform all clinical research activities in accordance with Human Subject Protection rules and Good Clinical Practice guidelines. Perform other related duties as assigned by the PIs, Sub-I’s.

Research Intern, Laurelton Heart Specialist PC. (Cardiology)

May 2014-Dec 2014.

(Internship)

Responsibility:

Ensure protocol, GCP, & regulatory compliance

Submission all Institutional Review Board document (IRB)

Review and submit inform consent form through central IRB for initial approval.

Maintain and update data at Trial Master File (TMF), Site Master File (SMF), Investigator Site File (ISF).

Budget (Create and negotiation).

Regulatory submission. (submission of 1572 and FDA form, protocol Signature Pages)

Carefully collect, compile and document clinical research data according to the study protocol and sponsor guidelines. Maintain documentation according to protocols, standard operating procedures, and FDA requirements.

Perform administrative tasks for the clinical research department including filing, appointment scheduling, phone follow ups, mailings, supply inventory, investigational product inventory. etc.

Work with Local or Central IRB as needed for approval for changes in ad Campaigns and Informed Consents etc.

During Monitoring Visit verify the rights & well-being of subjects are protected and data is accurate, complete & verifiable.

Screen patients to identify eligible study candidates through chart review, patient interviews, discussions with practice doctors, and other methods. Facilitate enrollment of eligible patients by working closely with physicians and staff. Explain studies to eligible candidates, answer questions, and obtaining written consent as delegated by the study PI.

Contact IVR or IXRS system to screen, screen fail and randomize the subject. Complete and upload visit to dispense subjects Medications. Upload subject’s status/visit tracking. Update and notify new drug shipment and supply management.

Always follow the rules with respect to regulatory document. Very realistic as well as economical to maintain the supply received from sponsor. Avoided unnecessary west of clinical supply. Very inclusive on paperwork. Always review the data and make adjustment as appropriate. Order Supply’s as timely fashion when it needed.

Train and mentor new staff on protocols, educate and train new research interns and medical assistants on clinical trials and procedures involved.

Arrange weekly meetings for PI and Site manager to conduct overall assessment of study procedures and update and educate staff on new protocols.

Perform basic clinical evaluations: including blood pressure, pulse, performing EKGs, phlebotomy, review current and changes to medications, document adverse events.

Assist the Clinical Research Manager and Assistant Managers in developing and improving processes to optimize efficiency and effectiveness of clinical research department.

Perform all clinical research activities in accordance with Human Subject Protection rules and Good Clinical Practice guidelines. Perform other related duties as assigned by the PIs, Clinical Research Manager, and Assistant Manager.

Pharmacy Technician, McDonald Pharmacy, NY

Mar 2010 - May 2014

In accordance with state and federal regulations, assists the pharmacist, under direct supervision, in the practice of pharmacy.

Assists the pharmacist in the performance of other Pharmacy Department duties in accordance with Company policies and procedures.

Responsible for using pharmacy systems to obtain patient and drug information and process prescriptions.

Perform pharmacy inventory control. Follow all applicable government regulations including HIPAA

Engages customers and patients by greeting them and offering assistance with products and services. Resolves customer issues and answers questions to ensure a positive customer experience.

Under the supervision by the pharmacist, assist in the practice of pharmacy, in accordance with state, federal, and company policy. Reviews and complies with the Pharmacy Code of Conduct.

Performs duties as assigned by Pharmacy Manager, Staff Pharmacist and Store Manager including utilizing pharmacy systems to enter patient and drug information.

Ensuring information is entered correctly, filling prescriptions by retrieving, counting and pouring pharmaceutical drugs, verifying medicine is correct, and checking for possible interactions.

Assists pharmacists in scheduling and maintaining workflow.

Reports, immediately, prescription errors to pharmacist on duty and adheres to Company policies and procedures in relation to pharmacy errors and the Quality Improvement Program.

Responsible and accountable for registering all related sales on assigned cash register, collects and handles cash as required.

Takes customer to OTC aisle when possible to assist in locating products.

Handles telephone calls that do not require personal attention of the pharmacist, including those to physicians.

Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the Pharmacy Manager.

Assists and supports Pharmacy Department on inventory management activities, such as, ordering, unpacking, checking and storing shipment of pharmaceuticals.

Assists Pharmacy Manager and Staff Pharmacist in developing and maintaining good relationships with the local medical community, including physicians, nurses, and other health care providers, by medical provider detailing and outreach to health groups, retirement homes, nursing homes, and other forums for enhancing growth opportunities.

Assists with exterior and interior maintenance by ensuring the Pharmacy Department is stocked with adequate supplies, clean, neat and orderly in condition and appearance.

Complies with all company policies and procedures; maintains respectful relationships with coworkers.

Completes special assignments and other tasks as assigned. Training & Personal Development

Maintains knowledge and skill in healthcare and pharmacy, including latest news and developments

Other Professional Experience

Amena Medical Center April 2008- August 2008

Laksam, Comillah, Bangladesh

Residential Medical Officer (RMO).

Prescribed medication for patients attending at morning in outpatient department. Regular

follow up of admitted patient in inpatient department in this hospital. Advise necessary investigation required for assessment of general condition of admitted patient, Transported patients to the surgery room,Prepared examination room and restocked examination room, Performed Pre-Surgical testing, Assist general and obstetric surgeons in major surgical procedures, manage post-surgical patient care and follow-up. Perform minor surgery like circumcision, small lipoma, conducting normal vaginal delivery (NVD), dilatation and curettage (D&C). Responsible for direct patient care, medication administration, care of patients at all levels of acuity, cardiac arrest. Insertion and care of Foley catheters, straight caths, NG tubes. Insertion and care of IV sites, blood draws, ABG’s, blood & urine cultures, EKG’s, administration of blood infusions. Cared for many types of wounds ranging from traumatic wounds such as GSW’s and stab wounds, to lacerations, as well as MVA’s and punctures wounds. Cleansed and bandaged using sterile techniques and multiple different types of dressings and treatments.

LAMB Hospital, Parbotipur, Dinajpur. Apr 2005-Apr 2008

Residential medical officer (RMO)

Gave prescriptions to patients attending at morning in outpatient department. Regular follow

Up of admitted patient in inpatient department in this hospital. Advice necessary investigation

required for assessment of general condition for admitted patient. Transported patients to the

surgery room,Prepared examination room and restocked examination room, Performed Pre-

Surgical testing, assist general and obstetric surgeons in major surgical procedures, manage

post-surgical patient care and follow-up. Perform minor surgery like circumcision, small lipoma,

and taking care of all outpatient emergencies. Performed ultrasonography for all pregnancy and

required surgical field.

Education

Bachelor of medicine, Bachelor of surgery. SZMC Medical college Bogra Bangladesh; Jan 2005

Research Support:

Pharmaceutical Companies:

Pfizer, Eli Lilly, Merck, Sharpe and Dohme, Takeda, Derma Sciences, Salix, Ardelyx, Amgen, Medimmune, ZsPharma, Akebia, Otsuka, Abbvie, Synergy, Sera Trials.

Central Laboratories:

PPD Central Laboratories, Covance Laboratories, ACM Global, Lab Corp, Quintals.

IRB:

Biomedical Research Alliance of New York (BRANY)

GWU IRB, WIRB, Schulman (SAIRB), Chesapeake (CIRBI), Coprenicus (CGIRB), Quorum Review IRB

Electronic Data Capture Systems & IWRS:

AlScript, Oracle OC-RDC, Inform, IMedidata Rave, Omnicomm, ICON Clinical, Single Interface, Data Labs, SureSource, VieDoc, Pfizer IMPALA. Clinphone, Almac IXRS, My Trial IVRS.

(REFERENCES ARE AVAILABLE UPON REQUEST)

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