Clinical Trials Specialist
Company Name:
Social & Scientific Systems (S-3)
Social & Scientific Systems (SSS) was founded by Herbert J. Miller, Denis Ables, and Mary Frances
leMat in 1978 as a small, minority-owned business. No longer a small business, SSS is now 100
percent employee-owned with approximately 500 employees working in the United States,
Africa, and Asia. SSS has supported public and private sector programs since its inception.
Our mission is to improve public health worldwide by providing technical, research, and program
management services to government and other clients. We achieve our mission through
significant contributions to public health research, international health programs, and health information dissemination. And, we do this in the context of our four core values: Exceptional Employee-Owners; Outstanding Client Service; Integrity and Viability; and Giving Back to the Community.
SSS is seeking a dedicated Clinical Trials Specialist to facilitate and document the development, implementation, and analysis of clinical trials.
DUTIES AND
Responsibilities:
Manage the development of 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; 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; prepare the sample informed consent for the protocol; coordinate protocol budget development; identify and resolve funding issues; monitor development of training materials; ensure all protocol 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; maintain current information in database and prepare study reports and protocol status updates.
Manage protocol implementation 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; monitor progress of open protocols; coordinate questions/issues from sites and ensure resolution of issues; track study monitoring and ensure safety reviews are carried out; maintain current protocol specific web page; maintain current database information for studies at all stages of development; 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.
Quality improvement: 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.
Supports Working Groups and Scientific Committees: Assist committee chair in setting agendas for conference calls and meetings and documenting decisions and tracking action items.
Bachelor's degree in science and at least four years professional experience in a scientific or health-related position with one year of experience in the design, development, conduct or analysis of clinical research. Clinical or laboratory experience preferred. Proficient in Microsoft applications.
SSS provides Equal Employment Opportunities (EEO) to all employees and applicants for employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Date: 2014-07-28
Country: US
State: MD
City: Silver Spring
Postal Code: 20910
Category: ResearchEstimated Salary: $20 to $28 per hour based on qualifications.
Social & Scientific Systems (S-3)
Social & Scientific Systems (SSS) was founded by Herbert J. Miller, Denis Ables, and Mary Frances
leMat in 1978 as a small, minority-owned business. No longer a small business, SSS is now 100
percent employee-owned with approximately 500 employees working in the United States,
Africa, and Asia. SSS has supported public and private sector programs since its inception.
Our mission is to improve public health worldwide by providing technical, research, and program
management services to government and other clients. We achieve our mission through
significant contributions to public health research, international health programs, and health information dissemination. And, we do this in the context of our four core values: Exceptional Employee-Owners; Outstanding Client Service; Integrity and Viability; and Giving Back to the Community.
SSS is seeking a dedicated Clinical Trials Specialist to facilitate and document the development, implementation, and analysis of clinical trials.
DUTIES AND
Responsibilities:
Manage the development of 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; 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; prepare the sample informed consent for the protocol; coordinate protocol budget development; identify and resolve funding issues; monitor development of training materials; ensure all protocol 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; maintain current information in database and prepare study reports and protocol status updates.
Manage protocol implementation 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; monitor progress of open protocols; coordinate questions/issues from sites and ensure resolution of issues; track study monitoring and ensure safety reviews are carried out; maintain current protocol specific web page; maintain current database information for studies at all stages of development; 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.
Quality improvement: 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.
Supports Working Groups and Scientific Committees: Assist committee chair in setting agendas for conference calls and meetings and documenting decisions and tracking action items.
Bachelor's degree in science and at least four years professional experience in a scientific or health-related position with one year of experience in the design, development, conduct or analysis of clinical research. Clinical or laboratory experience preferred. Proficient in Microsoft applications.
SSS provides Equal Employment Opportunities (EEO) to all employees and applicants for employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Date: 2014-07-28
Country: US
State: MD
City: Silver Spring
Postal Code: 20910
Category: ResearchEstimated Salary: $20 to $28 per hour based on qualifications.
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