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 candidate will support study sites in a Clinical Research Associate role under the supervision of a Clinical Project Manager. Additional duties include: site oversight and communication with sites and investigators, data entry, data management, maintaining up to date study documentation and exercising independent judgment in the resolution of problems. Preferably, the candidate has had some experience with site monitoring and has worked in the clinical research field.
Why work here?
Factory CRO is a global company with offices in The Netherlands and USA with expertise in a variety of fields. This broad knowledge pool, that all team members are willing to share, makes sure you learn something new every single day. Everyone at the company is offered the opportunity to develop her/his talents in the most efficient and intriguing manner.
Short communication lines make it possible to get involved with the required team members – whether this is someone from Data Management, Quality Assurance, the Management Team, or someone else – at any moment. And all this is offered in combination with a fantastic team of colleagues and at a desirable location!
Skills and Abilities Desired
- Ability to communicate, problem solve and work effectively in an international team
- Innovative and self-motivated
- Good organization skills and ability to prioritize goals and responsibilities
- Maintain confidentiality and comply with Health Insurance Portability and Accountability Act (HIPAA)
- Knowledge of GCP/CFR/ICH Guidelines
- Proficient in Microsoft Office
- Ability to learn new technology
Essential Duties and Responsibilities
- Coordinates and conducts site qualification, initiation, interim monitoring and close-out visits at study sites.
- Completes study reports in a timely manner.
- Maintains regulatory documents and ensures that they are up to date.
- Assists with IRB Submissions.
- Ensures all adverse events are documented accurately and in a timely manner.
- Monitors Data (on site or remotely). Reviews Case Report Forms for patient eligibility, protocol compliance, omissions, errors, etc. and performs source data verification.
- Ensure training/reference binders are maintained at each site.
- Assists with creation of training materials and trains study staff.
- Coordinates shipping of supplies to and from study sites.
- Enters clinical study data into study database.
- Travels to sponsor site for meetings as needed.
- Contributes to the team effort by accomplishing related duties as needed.
- Education: Bachelor’s degree in STEM field, or nursing degree
- Fluency in the English language
- Travel required
Job Type: Full-time; San Diego office based
For information and to submit your application please contact Sandy Gill (firstname.lastname@example.org; +1 619 505 2020).
Direct applicants only.