Social
& Scientific Systems, Inc. is looking for a Clinical Research Associate with
the following requirements and job description :
FUNCTION:
Responsible for performing and coordinating all
monitoring strategies for clinical research studies for the Indonesia Research
Partnership on Infectious Diseases (INA-RESPOND) Secretariat in Jakarta,
Indonesia (managed by Social & Scientific Systems, Inc. (SSS). Conducts site qualification (SQV), site
initiation (SIV), site monitoring (SMV) and site close-out visits (SCV) to
determine protocol and regulatory compliance.
Assures compliance with GCP, ICH, and SOPs set forth by SSS and its
clients. Exercises delegated training
and supervisory responsibility for CRAs assigned to a specific project.
DUTIES AND
RESPONSIBILITIES:
- Monitors activities at clinical study sites by conducting SQVs, SIVs, SMVs, and SCVs.
- Oversees and participates in identifying and recruiting physicians and study sites, verifying qualifications and capabilities to successfully manage and conduct clinical research.
- Maintains a professional working relationship with all clients, investigators and clinical study sites. Professionally represents SSS to all parties.
- Reviews and approves all essential documents required for implementing, monitoring and evaluating clinical research at assigned sites, per established guidelines.
- Monitors compliance with the established protocol, applicable Federal regulations and Institutional Review Board (IRB) requirements.
- Monitors the progress of clinical trials by verifying the accurate and complete collection/ recording of data on case report forms or database, without supervision.
- Reviews AE/SAE reporting for compliance with the protocol, national and local regulations and established guidelines.
- Completion of comprehensive monitoring reports and related correspondence in a timely manner following each monitoring visit, with no errors/edits needed.
- Reviews SSS and investigator study files to ensure compliance with all applicable regulatory and client requirements.
- Provides mentoring for CRA trainees in the field. Able to demonstrate the CRA’s role in preparing, monitoring, and reporting results of clinical trials.
- Keeps abreast of ICH/GCP guidelines, SOPs related to clinical monitoring and current clinical developments in assigned therapeutic areas, independently.
- Provides project management assistance as delegated, including monitoring report review, assisting in the design of protocol specific manuals and documents and team training
- Assists with development and review of clinical research site SOPs.
- Assists in the development of clinical research site staff trainings.
- Perform other duties as assigned.
- Ability to travel an annual average of 50% - 75%.
QUALIFICATIONS:
Education
and/or Experience:
- BS/BA in a life sciences program or field; nursing degree preferred, but not required
- Minimum two years as a clinical monitor, with documented experience in performing SQV/SIV/SMV/SCVs independently without supervision
Knowledge / Skills
/ Other Requirements
- Written and verbal fluency in English and Bahasa Indonesia
- Strong initiative and ability to work without supervision
- Strong organizational skills with keen attention to detail
- Excellent communication skills (written and verbal) with the ability to communicate effectively with clinical site staff
- Team player with a strong customer focus and excellent interpersonal skills
- Able to effectively manage multiple priorities within assigned tasks
- Comprehensive understanding of ICH/GCP guidelines, United States and Indonesian clinical research regulations, medical terminology and clinical research processes
- Demonstrated ability to mentor and train other monitors in a positive and effective manner
- Understands the relevance, importance, and inter-relationship of other departments to the success of the clinical research including data management, biostatistics, and regulatory-quality assurance
- Excellent computer skills and ability to learn and become proficient with appropriate software; working knowledge of Word, Excel, and PowerPoint.
- Ability to utilize problem-solving techniques applicable to constantly changing environment
- Prior experience in a Contract Research Organization (CRO) is preferred
- Prior experience working for a United States gov
To apply, please email your Resume/CV to Meity Siahaan at MSiahaan@s-3.com
Please write down the position that you'd like to apply in the subject line of your email.
Interested parties should respond immediately.
Application closing date: 15 June 2014.
