The document is a resume detailing an individual's professional experience, education, and skills, primarily in positions related to clinical research and human services management. It outlines responsibilities such as staff management, compliance with regulations, and clinical trial monitoring activities across various organizations. The individual is seeking a position to leverage their background and skills for career advancement.

1. A B O S E D E S A L A M I
1 4 4 - 1 1 1 8 1 S T P L A C E ~ S P R I N G F I E L D G A R D E N S , N Y 1 1 4 1 3
( 6 4 6 ) 2 8 3 - 7 1 1 6 ~ B O S K Y S A L @ Y A H O O . C O M
OBJECTIVE: To obtain a position to utilize my skills, educational background and experience, which will provide me an
opportunity for advancement and growth.
EXPERIENCE:
03/2010 – 07/2014 EIHAB Human Services – Queens, NewYork
Residence Manager
Ensure that the residence assigned is operating effectively and in compliance with the policies and procedures set by OPWDD.
Responsible for the handling of reporting of both incidents and behavioral problems; to ensure the appropriate follow-up of
such situations in compliance with the Agency Policies and Governmental regulations. To maintain administrative staff by
recruiting, selecting, orienting, and training employees. To monitor, as well as participating in client appointments, and
keeping the Director informed of each consumer medical situation. Bring knowledgeable of all required emergency procedures
providing leadership during the practice or actual drills. Providing staff coverage in the event of a shortage. Directly Manage
the assigned staff and review Performance on a regular basis. (annually, semi-annually etc.) Schedule clients for recreational
trips. Contributes to team effort by accomplishing related results as needed. Completes projects by assigning work to clerical
staff; following up on results. Accomplishes staff results by communicating job expectations; planning, monitoring, and
appraising job results; coaching, counseling, and disciplining employees; developing, coordinating, and enforcing systems,
policies, procedures, and productivity standards.
10/2011 - 04/2013 Satori Pharmaceutical Inc – Cambridge, MA
Clinical Research Associate I
Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely
manner. Knowledge of applicable SOPs, guidelines and study procedures; Assist with protocol and CRF review; Develop
informed consent forms; Conduct study feasibility and site selection activities. Assist with the development of study manuals,
annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials; Develop and implement
innovative approaches for and participates in site recruitment, selection and initiation activities. Assist with investigator
meeting activities including organization, preparation and attendance. Conduct site management activities, including but not
limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out v isits. Ensure
the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. Establish and maintain
good rapport with study sites. Write study visit reports and follow up letters within the timeline established by applicable SOPs
and guidelines. Coordinate timely shipment of clinical supplies and study drug to sites. Ensure proper storage, dispensation
and account ability of clinical supplies and study drug. Maintain adequate site tracking records. Follow up of drug safety issues
and safety reports in timely manner, if applicable. Communicate site study issues, concerns, and progress to Project Manager,
Clinical Team Lead, Regional Monitoring Manager and Clinical Operations Manager accordingly. Assist with data query form
(incl. query process).Perform telephone monitoring activities in order to obtain study status information. Development and
implementation of corrective actions when appropriate. Prepare /review all patients tracking records. Input and maintain study
information concerning subject status of financial reimbursement to sites. Conduct and assist with administrative activities as a
member of the project team. Mentor for Site Manager, when assigned. Conduct on the job training and formal training to other
CRAs and Clinical Trials Assistants. Collaborate with Regional Monitoring Manager or Clinical Operations Manager /study
teams to resolve site issues. Review study visit reports, follow-up letters and site communication generated by other CRAs for
timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead,
Regional Monitoring Manager or Clinical Operations Manager as needed. Participate in routine study progress meetings, face
to face or via teleconference.
04/2010 - 09/2011 Vioquest Pharmaceutical Company – Bridgewater NJ
Clinical Research Associate I
Assured compliance with CFR, State regulations, ICH and GCP guidelines as well as sponsor’s SOP’s. Maintained timely and
effective communication among team members and site staff. Regularly reviewed the status of contents of the site Regulatory
Binder. Assured Principal Investigator (PI) integrity. Assured timely reporting of AEs/ SAEs and Protocol Violations.
Performed source document verification (SDV) according to contractual requirements. Maintained current regulatory
documentation according to Essential Regulatory Document. Assured compliance with all protocol requirements. Assured
effective patient identification and recruitment plan is in place. Regularly performed Investigational Product (IP) accountability.
Completed and submitted visit trip reports according to SOP requirements. Updated study and patient status information and
served as (CTMS) resource for PM/LCRA. Documented and tracked the resolution of all outstanding site-specific protocol-
related issues from visit to visit. Assured timely completion and submission of CRFs according to Clinical Monitoring Plan
(CMP) and/or Data Management Plan (DMP).Attended clinical monitoring staff meetings, project team meetings, clinical

2. committees and clinical training sessions according to the project communication, monitoring and/or training plans. Conduct
the remote clinical monitoring aspect of designated projects. Build relationships with investigators and site staff remotely.
Perform remote clinical monitoring activities (issue resolution, patient enrollment management, handling protocol- and/or ICF-
and/or contract amendments, drug / supply management and ensuring timely data entry at a site level).Collaborate with CRA
on site issues/actions. Responsible for the completeness and quality of the electronic trial master file (in cooperation with
ROA/RMA).Update all relevant tracking system on an ongoing basis, including the maintenance of site staff details. Perform
regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS, ISIS).Serve as primary in-house
site support by conducting outbound and receiving inbound calls from study sites to: Review recruitment plan and enrollment
updates, Address/resolve issues pending from the previous visit, Address protocol questions, Check on site staff assignment,
Assess drug/study supply status, Request outstanding documents, Review site payment status, Follow-up on data entry, query
status and SAEs, Follow-up on appropriate site related questions, Maintain a working knowledge and ensure compliance with
applicable ICH-GCP Guidelines, local regulatory requirements and Omnicare Clinical Research and stud specific procedure
(e.g. Monitoring Plan).
EDUCATION:
08/2007 – 08/2009 Adelphi University – Garden City, New York
Bachelors in Science, (MSW)-Ongoing
11/2005 – 08/2006 State University of New York (Queens Educational Opportunity
Center) – Jamaica, New York
Major- Computerize Medical Billing (Certificate)
THERAPEUTIC AREAS:
Urology- Idiopathic Overactive Bladder, Benign Prostatic Hyperplasia
Dermatology- Male and Female Androgenic Alopecia
Central Nervous System – Alzheimer Disease, Depression
Neurology- Post Herpetic Neuralgia
COMPUTER SKILLS: Microsoft Office 2010, Excel, Word, Power Point, Outlook Inform, Medidata, Datalab,
CTMS, IMPACT Oracle Database Administration.
References available upon request