Clinical Research Coordinator II

Clinical Research Coordinator II

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 lifecyclefrom 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.

Major Duties & Responsibilities

Research

• 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

Other

• 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

Job Related Skills/Competencies

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)

Education/Qualifications

High school diploma required; Bachelor's degree in a health science or related field preferred

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

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

Current Medi-Waste Training for: Bloodborne Pathogens for Healthcare, GHS Hazcom, HIPAA, HITECH & Omnibus

Computer skills

Physical Requirements/Working Conditions

Must maintain a clean, healthful and professional appearance at all times and adhere to our uniform guidelines

Center Based: Requires working in a clinical setting. The noise level is moderate and there is a potential for exposure to infectious diseases and blood-borne pathogens as well as erratic/unpredictable patient behavior

The ability to stand and sit for 5 hours at a time, (with some bending and stooping); ability to use manual dexterity in relation to clinical requirements; use hands to finger, key, handle, reach; some bending, kneeling and stooping; ability to bend; and ability to lift and carry up to 50 lbs.

Ability to be punctual and maintain satisfactory attendance record

Ability to work flexible hours, including nights and weekends. Ability to work overtime should business need arise.

This job requires access to confidential and sensitive information, requiring ongoing discretion and secure information management

Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and ability to adjust and focus

Must be able to hear and speak effectively in English (bi-lingual in Spanish a plus)