DescriptionSHIFT: Work From Home
Clinical Research Associate - Work From Home
This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role.
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Development Innovations offers 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.
Sarah Cannon Development Innovations works 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 Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Sarah Cannon,the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
Summary of Key Responsibilities:
Perform routine site monitoring visits, participate in site selection, site initiation, and study closure activities to ensure that the clinical trial is being conducted according to the approved protocol, amendments and in compliance with Good Clinical Practice (GCP), Sarah Cannon and/or Sponsor SOPs, and all applicable regulatory requirements.Duties and Responsibilities:
Duties include but are not limited to:
- Assist in the Investigator selection and qualification process.
- Assist in the development of patient recruitment strategy.
- Attendance at Investigator Meetings.
- 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 colleagues 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 Sarah Cannon 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.
QualificationsEducation: Minimum Required: Bachelor's College Degree (4 year program) Preferred: Bachelor's College Degree (4 year program)
Experience: Minimum Required:
- At least one year of relevant experience as a clinical research professional (e.g., Clinical Project Associate, Research Monitor Associate, Clinical Data Analyst/Manager, Safety Lead, etc.), prior clinical/scientific background, and oncology experience
- One or more years of relevant experience as an SCRI clinical research professional (e.g., Clinical Project Associate, Research Monitor Associate, Clinical Data Analyst/Manager, Safety Lead, etc.), prior clinical/scientific research background, oncology experience, and successful completion of the SCRI CRA Academy
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.
Our Company's recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, let us know by clicking here.
For questions about your job application or this site please contact HCAhrAnswers at 1-844-422-5627 option 1.
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