Responsible for overseeing the implementation of daily clinical study activities. Serving as a liaison between the investigative site and the Sponsor. Responsible for accurately and ethically documenting all information obtained throughout the clinical research process.
Essential Responsibilities and Duties:- Provides general nursing care to study participants as necessary; including, but not limited to monitoring of vitals, blood sugar, vital signs, lab tests, etc.
- Reviews and executes clinical research protocols.
- Completes and maintains study documents in accordance with sponsor and site requirements.
- Possible recruitment of potential study subjects.
- Screens subjects for eligibility, and schedules subjects for study specific assessments, as designated on the Delegation of Authority Log.
- Completes and maintains Case Report Forms in agreement with the source documentation and in accordance with study protocol.
- Accompanies sponsor representatives during their visits and maintains effective and ongoing communication with the sponsor.
- Maintains adequate inventory of all data and supplies.
- Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
- Observes, documents, reports, and follows up on adverse events and serious adverse events.
- Conducts the informed consent process, per CenExel Standard Operating Procedures.
- Follows up appropriately on all laboratory results.
- Maintains safety standards when performing job responsibilities.
- Maintains study logs and site relations
- Ensures proper collection, processing, and shipment (if applicable) of laboratory specimens.
- Is on call to answer questions for other members of support staff, study patients or other medical staff, as necessary.
- Assists with quality assurance activities and completes queries, as applicable.
- Obtains Principal Investigator signatures on necessary documents.
- Oversees or coordinates the administration of investigational medication and follows
- subjects throughout the study stay, per protocol.
- Ensures accountability and adequate supply for study and clinical drugs.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:- Must be a Registered Nurse with a current license in CA
- Must be capable of performing all clinical tasks relevant to licensure and/or training.
- Must be able to clearly communicate verbally with patients.
- Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.
- Must be self-motivated and able to perform tasks independently.
- Ability to react calmly and effectively in emergency situations.
- Must reflect the professional image of the company, upholding the company vision in actions and demeanor.
Working Conditions:1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
