Clinical Research Coordinator II

Exer Medical Corporation•Los Angeles, CA

23h•$30 - $38•Hybrid

About The Position

The Clinical Research Coordinator II is a critical, high-autonomy role that makes clinical research accessible to our patient population while providing administrative support to the clinic. Working on behalf of the Principal Investigator (PI), this individual independently manages the full study lifecycle—from feasibility and start-up, through patient recruitment, eligibility assessment, and follow-up, to the preparation and gathering of all data and documents for this highly regulated process. This role is best suited to a coordinator who has run trials with significant independence at a smaller or independent site, is comfortable owning multiple functions at once, and can train and mentor less experienced coordinators as our research program grows.

Requirements

Effective use of computerized patient care system
Knowledge of medical terminology
Knowledge of all safety requirements when handling biohazardous specimens or contaminated instruments
Strong interpersonal skills to interact with patients, families, ancillary departments, physicians and co-workers in a courteous and compassionate manner
Strong, courteous and professional verbal skills to effectively convey sensitive information in a courteous manner in person or on the telephone; effective written communication and computer skills for proper charting
Ability to work well under pressure and be quick on your feet
Has a contagious and positive work ethic; models our core values
An effective team player who contributes valuable ideas and feedback and can be counted on to meet commitments
Proficient use of EMR and CTMS systems and ability to effectively use our systems within 2 weeks
Demonstrated ability to train, mentor, and provide constructive feedback to less experienced coordinators
Ability to independently manage multiple studies and competing priorities with sound judgment and minimal supervision, consistent with experience at a smaller or independent site
Proficient use of Microsoft (e.g. Office, Excel, Word)
High school diploma required
Minimum of 2-3 years of clinical research coordinator experience at an investigational site required, with solid knowledge of clinical trials terminology, processes, forms and reporting
Current Medi-Waste Training for: Bloodborne Pathogens for Healthcare, GHS Hazcom, HIPAA, HITECH & Omnibus
Computer skills

Nice To Haves

Bachelor's degree in a health science or related field preferred
Experience at a smaller or independent site network, with broad ownership across regulatory, recruitment, data, and monitoring-visit functions, strongly preferred
Prior experience training, onboarding, or mentoring other coordinators preferred
Certification (e.g. CCRC via ACRP or CCRP via SOCRA) a plus
Phlebotomy certificate preferred
bi-lingual in Spanish a plus

Responsibilities

Works with PI to meet or exceed study enrollment as per Sponsor’s inclusion/exclusion criteria
Complete feasibility questionnaires based on site information and all regulatory start up packages
Recruits and enrolls patents in a friendly and professional manner, screening for eligibility criteria
Conducts patient visit, collects all required data in appropriate formats, and follows up with all subjects as appropriate
Reports, tracks and follows up on an all adverse events, protocol waivers, deviations and violations
Complies with all study protocol, SOP and reporting requirements in a timely manner
Responsible for completion of all required documentation with keen focus on the integrity of the data submitted by careful source document review, monitoring for missing data and/or inconsistencies.
Maintains thorough and accurate records per regulatory/compliance standards at all times including but not limited to data for potential inspection; signed informed consents, source documentation, drug dispensing logs, subject logs, and all study related communication
Creates study specific tools for source documentation when not provided by sponsor
Collects, completes and enters data into study specific forms and/or electronic data capture system
Appropriately handles and records all specimens; prepares specimens for shipment; tracks all shipments; tracks all inventory and calibrations.
Attends relevant meetings (e.g. SIVs, PSSVs, IMVs, COVs, audits); assists Sponsor and FDA with any audits and responds to any monitoring/audit findings
Actively communicate with stakeholders as appropriate (Sponsor, IRB, vendors) and maintain active communication on status of each study with PI and management as directed
Trains, mentors, and provides day-to-day guidance to less experienced coordinators and clinic staff on research processes, GCP, and site systems; serves as a point of escalation for research-related questions
Independently owns day-to-day research operations for the site with minimal oversight, exercising sound judgment to prioritize competing study demands
Works in clinic to operate clinic cleanly, safely and efficiently
Prepares exam and treatment rooms per cleaning protocols; assists with all processes (within scope of certification) to maintain inventory of supplies, medication, and equipment necessary for the operation of the clinic.
Keys data into EMR/forms to maintain accurate office and patient records
Organizes tasks to facilitate smooth work/patient flow
Schedules and registers patients; referrals to specialists as appropriate
Handles routine administrative tasks (filing, correspondence, mail) as needed to support clinic operations
Adheres to all company policies and procedures, business conduct and work compliance standards
Will be required to travel and work at multiple clinics within a reasonable driving distance from home clinic
Any other task reasonably requested by company to meet its goals