Clinical Research Manager, Onsite
5 months ago
**ICLS Dermatology & Plastic Surgery** is looking for a **Clinical Research Manager** to join their growing team.
This position is a highly dynamic and evolving role involving clinical, administrative, communicative, and organizational skills. The **Clinical Research Manager** will work with the site staff under the leadership of the Principal Investigator and senior leaders with a wonderful team of coordinators, nurses and Investigators.
**We encourage pre-med students and individuals aspiring to enter med school to apply. It's worth noting that some of our most accomplished coordinators have used their experience here as a springboard to medical school**
**Responsibilities**:
- Design and implement study tools to monitor and track administrative and clinical activities including but not limited to the following: spreadsheets, databases, source documentation, educational materials and other duties as determined by the Team Lead.
- Travel to Investigator Meetings as required.
- Liaise with physicians, nursing, and laboratory staff, as well as industry representatives.
- Ensures that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
- Strong Standard Operating Procedures (SOPs) execution
- Keeps Team Lead and PI apprised and informed of all situations and daily operations.
- Escalates problems swiftly to appropriate parties; Team Lead, PI, Sub-I, and Monitor when applicable.
- Communicate with sponsors and their representatives as well as monitoring agencies or third parties in a respectful manner to schedule and complete tasks.
- Assist in planning and organizing of clinical trial start-ups including feasibility review, submissions when required.
- Strong background in clinical research regulatory requirements
- Collaborates and implements methodologies, policies, procedures, and standards in clinical research protocol management to ensure quality data including CAPA & ALCOA
- Advises key members on internal Quality Control (QC) findings and ways to continually improve.
- Regularly meets deadlines related to individual as well as team performance on projects/assignments.
- Support audit preparation for any site inspections
- Abide by and advise site on Good Clinical Practice (GCP), standard Operating Procedures (SOPs), company guidelines, and local healthcare and privacy regulations.
- Manage protocol-specific recruitment targets and support efforts to achieve site/company KPIs.
- Interact with investigators, and delegated team members and third-party vendors for successful study execution.
**Qualifications**:
- A Bachelor of Science, and/or Masters degree, and/or a level of education, training, and experience equivalent to a Bachelor’s degree in a science discipline or related field such as Health Administration, Nursing, Microbiology, or Business Administration.
- Minimum of five years' experience in **on-site** clinical research.
- Minimum of two years of successfully leading people.
- You demonstrate exceptional emotional intelligence, approach situations with empathy, and exhibit a strong willingness to constantly be learning
Our selection process is open to all applicants who meet the specified criteria, regardless of their academic or professional backgrounds. We believe in fostering a diverse and inclusive environment that welcomes motivated individuals from various educational paths.
**Job Types**: Full-time, Permanent
Pay: $28.00-$35.00 per hour
**Benefits**:
- Dental care
- Flexible schedule
- Life insurance
- Paid time off
- Store discount
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Application question(s):
- What is your highest level of education and what did you study?
**Experience**:
- Patient facing: 1 year (required)
- Onsite Clinical Research Coordinator: 5 years (required)
- People Management: 2 years (required)
Work Location: In person
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