Social & Scientific Systems, Inc. (SSS), a company dedicated to improving public health around the world, is looking for a dedicated Clinical Trials Specialist (Temporary) to facilitate and document the development, implementation, and analysis of clinical trials.
PLEASE NOTE: This position is temporary and non-benefitted and will last from July through December 2013.
DUTIES AND RESPONSIBILITIES:
I. Manage the development of protocols/amendments; collaborate with teams to develop & write protocols/amendments.
Organize and guide protocol team in protocol development and review process; educate new members to group process; plan protocol development and project management with protocol chair and key team members; apply project management techniques in the protocol development process; establish schedules and maintain and monitor timelines during protocol development; collaborate with operations center staff, investigators and committees, industry representatives, laboratory and contracts personnel, statistical and data management centers, community groups, regulatory personnel, and contract representatives; coordinate, participate in, and document protocol team meetings and conference calls with decisions and action items; identify and anticipate issues that impede protocol development for discussion and resolution; track and follow through on action items and recommended interventions; facilitate team communication and serve as point of contact for non-team members; prepare first, subsequent, and final drafts of protocols and protocol amendments, independently incorporating team decisions into documents; prepare the sample informed consent for the protocol; coordinate protocol budget development; identify and resolve funding issues; monitor development of training materials, protocol support documents, including laboratory documents, and the protocol specific web page; ensure all protocol reviews are completed; ensure all team, external, and internal quality reviews are completed; ensure all review comments are addressed or incorporated into the protocol document; conduct and summarize site surveys; coordinate completion of final study prerequisites, including contracts, data management forms, drug supply acquisition, and regulatory requirements; maintain current information in database and prepare study reports and protocol status updates.
II. Manage protocol implementation (pending & open studies), and study closure processes through study completion
Facilitate protocol opening process; disseminate information to study sites and participants; provide information and guidance regarding protocol implementation and management to protocol team, the operations center, study coordinators, laboratory personnel, and others; monitor progress of open protocols, including accrual, toxicity, study specimens, and communications with study personnel; coordinate questions/issues from sites and ensure resolution of issues; track study monitoring and ensure safety reviews are carried out, and letters are drafted and disseminated; maintain current protocol specific web page; maintain current database information for studies at all stages of development; facilitate status reports for group leadership and operations center; collaborate with protocol team and regulatory personnel to develop letters of clarification, letters of amendment, or full protocol amendments as needed; participate in study closure processes; collaborate with publications coordinator regarding manuscripts, and with team members, guiding them to ensure all procedures are followed and communicated; monitor abstract, closure, and manuscript timelines; contribute to the development of the protocol publication, as invited.
III. Quality improvement - initiate/participate in activities to improve the overall quality of work and the working environment.
Initiate and participate in activities to improve the overall quality of work and the working environment; contribute to project and staff meetings; facilitate communication, and problem identification and resolution within the operations center and with the client to facilitate work processes; provide peer review of protocol documents; mentor new staff; initiate/participate in working groups for the development and revision of training, protocol development, and project management documents and guidelines.
IV. Supports Working Groups and Scientific Committees, if assigned
Assist committee chair in setting agendas for conference calls and meetings and documenting decisions and tracking action items.
Bachelors degree in science and four years professional experience in a scientific or health-related position with two years of experience in the design, development, conduct or analysis of clinical research or clinical care; or non-science degree and five years of experience in a scientific or health-related position with two years of experience in the design, development, conduct or analysis of clinical research or clinical care. Masters degree preferred. Must be proficient and have experience in Microsoft Word, Excel, Outlook, and PowerPoint.
This position is based in our Silver Spring, MD office. SSS offers an excellent total compensation package, including medical, life, and disability insurance, annual leave, stock ownership, 401(k) plan, education assistance, casual work environment, commuter benefits, flexible hours, and more.
Review full requirements/description and apply online at www.s-3.com - see Req. #1155.