Astera
Location
East Brunswick, New Jersey
The Clinical Research Coordinator will provide overall coordination for study-related activities for patients in cancer research studies, ensuring activities adhere to local and federal regulations and sponsor policies. Responsibilities include assisting with IRB submissions, maintaining regulatory documents, coordinating patient tests and visits, and entering research data into a centralized database.
A Bachelor's degree or equivalent experience is required, along with at least one year of clinical research experience, preferably in Oncology. Preferred qualifications include Pharmacy Technician certification with infusion drug preparation training and experience with EDC, IWRS, CRF, and Microsoft applications.
As an Oncology Clinical Research Coordinator (CRC), you will be an integral part of studies at Astera Cancer Care by recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position. Responsibilities Include: Provide overall coordination of study-related activities for patients enrolled in cancer research studies through the Astera research program. Coordinate with Principal Investigators, Supervisor and study sponsors and CROs to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs. Assist in the coordination of tests and visits for patients and collaborate with the Astera study team to maximize work efficiency and productivity. Assist in IRB submissions and interact with the Supervisor to maintain regulatory documents and administrative files for each protocol. Work with research nurses, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials. Maintain patient and regulatory research records. Confer with all members of the clinical team to confirm appropriateness and timeliness of tests. Collect follow-up data on patient’s post-treatment as required by the protocol. Submit weekly reports to Supervisor, tracking patient screening/enrollment and subject status. Enter research data into a centralized database as per protocol requirements. Attend investigator meetings as required or requested by the Principal Investigator. Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. If applicable, able to prepare blinded and unblinded study drugs. If applicable, act as primary coordinators for unblinded team.
A Bachelor’s degree or equivalent working experience required. Pharmacy Technician certified with infusion drug preparation training preferred. At least one (1) year of clinical research experience, Oncology experience a plus. Experience in Oncology Patient Recruitment and retention skills. Experience with EDC, IWRS. CRF and Microsoft applications. Able to travel between offices within the offices in Northeast Jersey area. Excellent communication skills. Excellent time management skills. We are proud to offer a comprehensive benefit package and paid time off. The health benefits include immediate eligibility for medical, dental, vision, life, disability, HSA, FSA and other ancillary benefits. We also offer a 401(k) plan with company contribution, profit sharing, tuition assistance and employee referral bonus. Astera is here to help patients overcome cancer and blood diseases, and improve their quality of life. We’re on a mission to transform cancer care and the care and management of blood disorders with patient-focused, research-based treatment, guided by compassion. To fulfill our mission, we’ve built a cancer care team that is: Diverse Talented Experienced Highly trained Deeply committed We are: Medical Oncologists Radiation Oncologists Hematologists Infusion Specialists Nurse Practitioners Nurses Pharmacists Pharmacy Technicians Medical Assistants Billing Experts Support Staff Each member of our team is dedicated to providing the highest standard of care and support to all of our cancer and hematology patients. We are proud to offer a comprehensive benefit package and paid time off. The health benefits include immediate eligibility for medical, dental, vision, life, disability, HSA, FSA and other ancillary benefits. We also offer a 401(k) plan with company contribution, profit sharing, tuition assistance and employee referral bonus.
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