• Provides operational oversight across multiple projects and programs to ensure assigned Project Managers and Project Teams are meeting ARGs requirements for Quality and consistency, and work is being completed in accordance with the project’s timelines and budget as set forth in the agreed upon scope of work (Work Order) on each project; • Develops positive relationships with clients to ensure expectations are met and ensures clear communications within the project team; • Acts as a point of escalation contact for project team members and clients in resolving project related challenges; • Plays an active role in the execution of project deliverables, may have direct project accountabilities/assignments; • Provide direct supervision, support, training and mentoring to project managers;• Ensures ICH/GCP, CFR (and other applicable local or national laws/regulations) and applicable SOPs, processes, policies and procedures are adhered to, ensures process improvement feedback is provided to appropriate Senior Management;• May have direct reports in which the PD will prepare and conduct performance appraisals;• Works with Senior Management in support of ARG’s corporate initiatives;• Supports business development activities as required;• Other duties related to corporate goals or initiatives as directed by Senior Management.

o Communicate effectively with clients to identify needs and evaluate alternative business solutions.o Continually seeking opportunities to increase customer satisfaction and deepen client relationships.o Creating and executing project work plans and revising as appropriate.o Creates and/or reviews prepared deliverables before passing to client.o Effectively applies SOPs, ICH, GCP, and FDA guidance’s as well as enforces project standards.o Prepares for project reviews and quality assurance procedures.o Ensures project documents are complete, current, and stored/filed appropriately.o Facilitates team and client meetings effectively.o Holds regular status meetings with project team.o Keeps project team well informed of changes within the organization and general corporate news.o Effectively communicates relevant project information to superiors.o Resolves and/or escalates issues in a timely fashion.o Works to train other team members and clients through both formal and informal training programs.

· Development and implementation of Standard Operating Procedures (SOPs) for Atlantic Research Group (Clinical Research Organization); · Responsible for incorporating FDA, ICH and GCP principles and guidances in all new and existing SOPs; · Final approval and continuous review of existing SOPs on a twelve month periodic basis.

Help manage study and site start up by reviewing site and sponsor budgets, distributing and tracking essential documents and FDA and IRB submissions. Responsible for distributing and tracking Clinical Trial Agreements; participate in CRF development and source document worksheet development.Clinical Monitor for Biotech Sponsored Clinical Trials; verify eligibility, source and CRF data, review drug accountability and regulatory documents for compliance with the study’s protocol, ICH, GCP and FDA regulations and guidelines. Help manage study feasibility questions, organize and initiate study startup; correspond with both prospective and active sites. Responsible for assisting in training of research personnel in study procedures and regulatory guidelines; prepare and present study of interest to site research personnel and at sponsor/investigator meetings. Assist in training personnel in data capture with source document worksheets and CRFs including both paper and electronic data capturing methods. Correspond with site research personnel to track site progress with regards to patient screening and enrollment on a weekly basis. Troubleshoot enrollment issues with sponsor, team and site personnel. Responsible for organizing site qualification, initiation, interim monitoring and closeout visits with the site’s research staff. Research and prepare study newsletters distributed to all participating sites, sponsor and team members.Assist in the development and implementation of Standard Operating Procedures (SOPs) for Atlantic Research Group (Clinical Research Organization).

Monitor for seven HITC Investigator initiated clinical trials• Review each subject to confirm eligibility by meeting the study’s inclusion/exclusion criteria.• Make sure protocol specifications were adhered to while each subject was actively participating in the study.• Verify correct recording and reporting of data according to the protocol’s data safety monitoring planManage Multi-Institutional (MI) Clinical Trials for three ongoing studies involving Melanoma Cancer Research:• Liaison for MI sites regarding protocol and operational procedures.• Monitor and manage all study related data on each patient enrolled in two separate melanoma MI trials. o Monitor/QA patient data and regulatory documentationo Manage all data querieso Manage drug accountability associated with each studyo Manage regulatory files• Screen, randomize, and enroll patients in melanoma MI study.• Correlate with MI sites in shipping and receiving study related drug and syringe supplies.• Responsible for updating study case report forms and standard operating procedures for each trial.• Participate in weekly and monthly meetings to help facilitate and solve group issues.• Co-Study Chair Liaison for a cooperative group study.o Providing protocol and clinical monitoring support for participating sites.o Manage eligibility blood shipments and results.o Manage syringe requests from multiple participating sites.Clinical Research Coordinating• Review and provide feasibility assessments for trial logistics.• Study coordinator for HITC and Pharmaceutical Sponsored Clinical Trials:o Coordinate study procedures and operations between participating support staff to successfully enroll patients onto study.o Review and assist with case report form development and completion.o Consent, screen, enroll and follow participants for study.

Analysis:• Data analysis by DeNovo Sequencing• Responsible for preparing and running all MALDI-TOF samples and prepare data to be sent to investigators• Prepare samples and operate LCQ-Ion Trap ESI/MS/MS and ICRFT instruments.• Update database, perform database searches, and keep current data entries

Management and Projects: · Lab Manager for seven months · Maintain lab efficiency from ordering supplies to scheduling and carrying out experiments related to identifying and characterizing new emerging proteins from the Human Sperm Proteome to further contraceptive research. · Keep records of group projects; update proteome database and perform database searches. · Initiate the design and construction of an online database to store and accommodate future implications of all the data generated by the lab as a whole. · Perform experiments using molecular biology and biochemistry techniques; train lab personnel in two-dimensional gel electrophoresis procedures.Presentations: · Organize and present data at monthly group meetings, semi-annual and annual meetings both domestic and international. o 3/02 ­ Center for Research in Contraceptive and Reproductive Health meeting,