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Clinical Ressearch Associate II

Medicines360

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Location: San Francisco, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: 2013-04 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research
Gynecology
Nursing

Description

MISSION
Medicines360 is a non-profit pharmaceutical company that addresses unmet needs of women by developing innovative, affordable and sustainable medical solutions.

POSITION SUMMARY
The Clinical Research Associate II (CRA II) will work closely under the supervision and direction of the Senior Director, Clinical Operations to ensure study compliance and adherence to regulatory requirements.

•Dependent on experience and abilities will have increased self-directed responsibility for study management activities.
•Assist in site management and site monitoring at designated clinical research sites.  
•Support designated Clinical Operations staff in management of all clinical aspects of study.
•Support designated Clinical Operations staff in follow up resolving protocol questions and issues related to the study.  
•Support study team in review of protocols, informed consent forms, case report forms, monitoring plans, or clinical study reports, and resolution of data discrepancies.
•Participate in abstract presentations, oral presentations, study newsletter and manuscript development.

ROLE QUALIFICATIONS:
•Degree of independence, self driven, rapidly drives solutions & multi-tasking
•Has appropriate experience and judgment to recognize when to escalate issues or consult with appropriate colleagues
•Ability to identify problems and creatively solve them
•Innovative, technical, resourceful and well organized
•Make informed decisions quickly, keeping performance on track
•Capable of prioritizing, handling multiple projects simultaneously
•Performs follow up without being reminded to do so
•Communication and ability to effectively work with others; good interpersonal and collaborative skills a must
•High level of enthusiasm, personal sense of urgency and capacity to overcome obstacles

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (Other duties may be assigned):

•Assist in the development and tracking of study timelines and budgets.
•Coordinate other study-wide activities such as sample handling, drug re-supply, and investigator payments.
•Assist in maintaining a complete and updated regulatory file for each assigned site.
•Partner with Data Management to ensure that data at site(s) and study levels are reviewed and discrepancies are communicated and resolved timely.
•Assist in the development of key study documents, including Protocols and amendments, Final Study Reports, Monitoring Plans, and site educational and reference materials.
•Assist with formatting/production and distribution of key study documents such as investigator brochures, protocols, interim safety reports and site communications
•Participate in teleconferences with CROs and Clinical group.
•Assist in follow-up activities for action items related to CROs.
•Site monitoring; including collecting, processing, and reviewing case report forms.
•Assists with the overall planning, development, and data management of one or more clinical investigations, including the preparation, writing, and completion of required documents.
•Support the development of company SOPs and guidelines.
•Assists in the preparation and completion of IND, BLA, and NDA documents, as well as annual reports and final safety reports.
•Collaborates in development and maintenance of status reports, SOP revisions and document quality control.
•Track clinical trial supplies, patient recruitment activities, (diaries) for accuracy and completeness and conduct query resolution.
•Assist in preparation of meeting materials.
•Support developing Newsletters.
•Contribute to protocol amendments and informed consent form templates.
•Support forecasting and monitoring of overall drug supply and expiration to ensure adequate availability throughout trial.
•Assist in study-wide activities such as central lab activity, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality.
•Exercise sound judgment, as appropriate to seek expert input on protocol and drug questions, safety, regulatory, and legal issues.

Requirements

EDUCATION and/or EXPERIENCE
•Bachelors in biological sciences, nursing or other related discipline
•Clinical research experience within the biotech/pharmaceutical industry, in women’s health highly desirable, with a minimum of 1 year of clinical research and co-monitoring experience required.
•Knowledge of medical practice, techniques and terminology.
•Knowledge of US and GCP/ICH regulations governing clinical trials.
•Organized and detail-oriented individual with excellent writing, analytical, technical and interpersonal skills.
•Outstanding written and verbal communication skills including proven ability to effectively collaborate with clinical study team, cross-functional team, Quality control and manufacturing and external parties in a rapidly growing environment
•Mature, energetic with a ‘let’s roll up our sleeves’ attitude which is especially important in a small but growing organization.
•Proficiency in Microsoft Word,  Excel, Outlook, Power Point and Adobe Acrobat
•Travel up to 80% or as necessary
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