Department: Medical Affairs
Reports To: Clinical Research Manager
FLSA Status: Exempt
The Clinical Research Associate monitors activities at clinical research study sites and assures adherence to study protocols and SOPs.
Essential Duties and Responsibilities:
- Coordination and management of clinical trial sites
- Monitor via on site visits and via remote review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP, checks if IRB approvals are still valid and in place.
- Review in time the eCRF data collection system on completeness and timely query resolution and closure.
- Site management: build and maintain good relations with investigators and site staff.
- Ensure that patient enrolment on site follows agreed recruitment plan
- Close down study centers on completion of the trial.
- Ensure that study staff conducting the protocol has received the proper materials and instructions to enter patients into the study.
- Ensure that the rights, well-being, and safety of human subjects are protected by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements.
- Ensure data is submitted on Case Report Forms (CRFs) or other data collection tools.
- Monitor data for missing or implausible data.
- Maintain proper documentation of all site correspondence.
- Assist in the training and mentoring of personnel.
- Contact and troubleshoots non enrolling sites.
- Perform monitoring and performs clinical closeouts in one or more programs.
- Performs other related duties as required or assigned
This position may interface with all departments within the company as well as outside vendors and regulatory agencies.
Education and Experience Requirements:
- Bachelor’s degree in Life Sciences (e.g., Biology, Nursing, Pharmacology)
- 1 + years site monitoring experience
- 2 + years experience working in Oncology (as a monitor, coordinator, or nurse)
- In-depth experience with each stage of a clinical trial (i.e. study start-up through archive) and study site management
- In-depth experience with each type of site monitoring visit (pre-study, initiation, interim, close-out)
Certificates and License Requirements:
- Completion of ICH/GCP course
Skills and Qualifications Requirements:
- Thorough knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
- Customer service orientation
- Sound knowledge of medical terminology and clinical monitoring process
- In depth therapeutic and protocol knowledge as provided in company training
- Excellent verbal and written communications skills
- Excellent interpersonal and organizational skills and attention to detail
- Computer literacy, proficiency in MS Office
- Strong Leadership Skills
- CCRA Certification – Association of Clinical Research Professionals
- This position requires no supervisory responsibilities.
- General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintains a clean, neat, and orderly work area.
- Adheres to Department Specific Safety Guidelines.
- Experience working remotely/home office
- Up to 50%
- Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 15 pounds.