Position Title: Clinical Research Associate I
Reports To: Clinical Trial Manager
Status: Full time / Non-exempt

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

POSITION SUMMARY
The Clinical Research Associate I (CRAI) will work closely under the supervision and direction of the Clinical Trail Manager (CTM) 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 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.

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.