Clinical Research Associate II

HCA Edison , NJ 08817

Posted 2 months ago

Clinical Research Associate II - Work From Home

Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is committed to oncology. We offer a strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.

Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.

We work with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows us to offer sponsors access to a diverse and dynamic patient population, spanning multiple tumor types and disease stages. These relationships further improve the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support.

Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to state of the art therapies for those facing cancer in communities across the United States and United Kingdom.

This is a Work from Home position and you can be located anywhere in the United States to be eligible for this role.

Duties and Responsibilities:

Duties include but are not limited to:

  • Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company standard operating procedures, applicable regulatory requirements and defined quality and performance standards

  • Ensure site IRB approval is current and all IRB documentation is in order

  • Maintain site monitoring schedule and serve as the principal point of contact for investigational sites

  • Document and report on clinical study progress (i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members)

  • Ensure patient safety is maintained and informed consent procedures are carried out

  • Provide training and update investigative site team of any changes in study conduct and documentation requirements

  • Ensure continued acceptability of the investigator, clinical site team and facility

  • Review clinical data, source documentation, CRF, and investigative site regulatory files

  • Work closely with data management and site to resolve discrepancies

  • Ensure investigational product accountability accuracy and oversee investigational product inventory

  • Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies

  • Meet with clinical study sponsor representatives as requested

  • Submission of routine monitoring visit reports and follow-up letters as per required timelines.

  • Ensure resolution of issues with investigative sites

  • Attend meetings as assigned and report on actions

  • Participate in educational activities and programs

  • Maintain strictest confidentiality

  • Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct

  • Assist other staff as requested and perform other related work as needed

  • Function as a mentor for team members

  • Maintain awareness of current developments in therapeutic area relative to assigned projects

  • Throughout the conduct of the clinical trial assesses adherence to SCRI

SOPS, GCP and all applicable regulatory requirements

  • Travel is required. May also involve travel to meetings or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs

Qualifications

Education:

Minimum Required: Bachelor's College Degree (4 yr program)

Preferred: Bachelor's College Degree (4 yr program)

Experience:

Minimum Required:

  • Three years direct monitoring experience or equivalent; combination of monitoring experience with previous work in the clinical research industry may also be considered

Preferred:

  • Three years direct oncology monitoring experience

  • Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and closeout)

Do you find this opportunity compelling, if so we encourage you to apply? We promptly review all applications. If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.

We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.


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Clinical Research Associate II

HCA