Milestone Research, a Factory-CRO company is a Contract Research and Reimbursement Organization focused on providing custom solutions tailored to the needs of the medical device and biologics industry. We specialize in clinical/regulatory affairs and reimbursement for innovative technologies and organizations of all sizes.
For our San Diego (CA) office Factory-CRO is seeking a highly motivated and hardworking individual interested in broadening their experience in clinical research.
The main responsibility of this position is to complete the clinical trial oversight and clinical project management tasks related to the execution of the clinical study assigned by the Project Manager. At management discretion, may serve as a Project Lead provided the named personnel have the appropriate qualifications and training to perform the role.
Clinical Trial Monitoring:
- Oversee clinical trial activities at investigational sites (will require travel to investigational sites).
- Conduct and write accurate reports on site monitoring for clinical trials in accordance with BBA standard procedures, ICH guidelines and GCP, including pre-study, site initiation, routine monitoring, and close-out visits.
- Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
- Ensure data entry by investigational sites is accurate and entered in a timely manner
- Conduct or participate in data reviews, both internally at BBA and with sponsor, collaborating with data management personnel as appropriate, identifying and communicating trends or erroneous data.
- Monitor site’s completion of action items between visits; monitor site’s performance centrally utilizing BBA’s electronic tools.
Perform Lead Monitor Responsibilities:
- Oversee compliance with Monitoring plan
- Oversee monitor activities at investigational sites
- Ensure site visits are conducted according to study budget.
- Ensure timely close of all site action items
- Ensure queries are responded to and closed in a timely manner.
May Perform Project Management Activities:
- Overall clinical project manager on multi-department studies.
- Establish expectations and standards for project core team.
- Direct team meetings provide consistent reporting and updates to all applicable team members and management.
- Provide up to date information and proactive communication with project teams on all subjects and site matters.
- Provide feedback to cross-functional team on protocols.
- Manage team deliverables and communications.
- Participate in staff and team development meetings.
- Responsible for developing study specifications.
- Ensures overall study compliance.
- Monitors and evaluates clinical study budget.
- Provides proactive mitigation strategies for those budget items identified as having significant variance.
May Perform Medical Writing Activities:
- Responsible for developing and writing clinical protocols, clinical study reports, clinical evaluations/literature reviews, and associated clinical investigational plan elements.
- Prepares materials for investigator meetings, client meetings, study site training, etc.
- Collaborates with applicable departments and project teams to ensure documentation meets study needs.
- Approves some work of others.
Mentoring of Jr. Staff Members:
- Provides guidance and oversight of tasks associated with clinical trial monitoring.
- Attend monitoring visits as the co-monitor to train and assess performance
Skills & Requirements
- B.A./B.S. or equivalent experience in science or health related field.
- At least 7 years of work experience in clinical research as a consultant in the health care industry, in particular as a clinical research associate or monitor.
- Excellent organizational, interpersonal, and communications skills.
- Ability to write clearly in emails, visit reports, and other clinical trial documentation.
- Ability to work both independently and in a team while generating quality project deliverables.
- Familiarity with current Good Clinical Practices.
- Willingness to travel as project dictates.
Job Type: Full-time; San Diego office based
For information and to submit your application please contact
Courtney Taylor, firstname.lastname@example.org, phone: +1 (508) 351-8632
Direct applicants only.