GreensboroRecruiter Since 2001
the smart solution for Greensboro jobs

Senior Clinical Research Associate

Company: Sarah Cannon
Location: Greensboro
Posted on: March 25, 2020

Job Description:

SHIFT: Work From Home SCHEDULE: Full-time Senior 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 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 The Senior CRA is a high-profile role within the department; using their experience as a knowledge resource to help other CRAs develop their skills. The SCRA will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with Sarah Cannon or client s standard operating procedures (SOPs), clinical monitoring plan, IC GCP, regulatory requirements, ensuring study completion on time and within budget. They may be called upon to interact independently with clients not directly involved in their projects, and to assist in some relevant departmental tasks. The SCRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project. The degree of responsibility given to a SCRA shall reflect his/her experience and the level of contribution, which he/she can make to that project. Duties_Include_But_Are_Not_Limited_To * Reports directly to Manager, CRAs on general issues * Reports to the Project Manager or Project Lead for study specific issues * Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements * Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project for agreement with the Development Innovations Monitoring Management Team, and conducting agreed co-monitoring visits with members of the Development Innovations Monitoring project team * Ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood * To be accompanied by Project Manager, Project Lead, or CRA Manager on selected visits (qualification, initiation, monitoring, and close out visits.) * To support the development and delivery of department training days * Actively participate in training sessions and workshops, including presenting reports from any conferences attended * 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 SOPs, 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 Education Qualifications Minimum Required: Bachelor's College Degree (4 year program) Preferred: Bachelor's College Degree (4 year program) Minimum_Required Experience: * Three years direct oncology monitoring experience in Phases l - lll * Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out) * Demonstrated leadership skills Preferred * At least five years direct oncology monitoring experience in Phase l lll in solid and liquid tumor types * Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out) * Demonstrated leadership skills * Previous experience in a Sr. CRA role, preferred 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. Notice Our Company s recruiters are here to help unlock the next possibility withi 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- option 1.

Keywords: Sarah Cannon, Greensboro , Senior Clinical Research Associate, Healthcare , Greensboro, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


CVOR Nurse
Description: CVOR Nurse Job in Chapel Hill, NC br br Soliant is partnering with a prestigious hospital in Chapel Hill, NC to fill a traveling need they have for a CVOR RN. br br Your present circumstances (more...)
Company: Soliant Health
Location: Chapel Hill
Posted on: 04/10/2020

Electrophysiology Lab RN 4x10 hour shifts, Circulate Only
Description: Cary, NC - I am looking for an EP Lab circulator a 15 week travel job opportunity in the Cary, NC area. This job opportunity if fifteen 15 weeks. While previous Cath Lab experience is a plus, any nurse (more...)
Company: Soliant Health
Location: Cary
Posted on: 04/10/2020

Plasma Center Nurse - Licensed Practical Nurse / LPN
Description: Job Description For more than 75 years, Grifols has worked to improve the health
Company: Grifols
Location: Danville
Posted on: 04/10/2020


RN- Nephrology Oncology PRN
Description: Job Details Company Overview Frye Regional Medical Center Performs plan of care intervention, including medication administration, specimen collection, clinical
Company: Frye Regional Medical Center
Location: Hickory
Posted on: 04/10/2020

Travel Nurse (RN) Postpartum (Mother-Baby)
Description: This is a travel Nurse - Postpartum assignment in Fayetteville, NC, working nights. Don't miss this exciting Mother-Baby travel RN
Company: Emerald Health Services
Location: Fayetteville
Posted on: 04/10/2020

Respiratory Therapist
Description: Hickory, NC needs a travel Respiratory Therapist Local candidates are encouraged to apply br br Position-
Company: Sunbelt Staffing
Location: Hickory
Posted on: 04/10/2020

General Surgery - Nurse Practitioner Opportunity
Description: Centra Medical Group, located in Lynchburg, VA, is seeking------a Nurse Practitioner to work with our General Surgery patients.------ br br Position------includes general duties to include working (more...)
Company: Centra Medical Group
Location: Lynchburg
Posted on: 04/10/2020

Hickory, NC- Hospital Seeking Travel Cath Lab RN
Description: Whatever you are, be a good one. -Abraham Lincoln br br Hickory, NC - Hospital Seeking Travel Cath Lab RN br br Our client in
Company: Soliant Health
Location: Hickory
Posted on: 04/10/2020

Psychologist (Psych)
Description: Psychologist Psych br br There is an opening for a Psychologist in a school district near Danville, VA. The Psychologist is to be placed
Company: Soliant Health
Location: Danville
Posted on: 04/10/2020

Vascular Ultrasound Technician
Description: Travel Vascular Ultrasound Technician Numerous Nationwide Travel Assignments / Jobs br br Tired of completing an application just to get informationClick the View or Apply button for HCEN's Free, (more...)
Company: HealthCare Traveler Jobs
Location: High Point
Posted on: 04/10/2020

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Greensboro RSS job feeds