Clinical Research Coordinator Lead

Description

GENERAL SUMMARY

The Lead Clinical Research Coordinator independently manages high-acuity clinical trials, ensures strict regulatory compliance, and provides operational leadership and mentorship to research support staff under the direction of the Principal Investigator. 

Requirements

ESSENTIAL JOB FUNCTION/COMPETENCIES

The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to:

• Provide training, workflow guidance, and peer review for Clinical Research Coordinators and Research Assistants.
• Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals.
• Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
• Coordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability.
• Data collection and management, collection and development of source documents, use of CRFs, managing patient registration, AEs, filing and archiving, managing monitoring visits, dealing with queries.
• Maintain accurate records of the receipt, inventory, and dispensation of study drug and obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
• Patient visits, data collection and transcription/EDC, prepare for monitor visits, protocol adherence to include height, weight, blood pressure, respirations, pulse temperature, O2 saturation.
• Schedule appointments and organize materials to be used during study visits and ensure that all required tests are completed for each study visit per protocol.
• Includes initial study start-up information/ requirements, dissemination of updated Investigator’s Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study.
• Completes Source Documentation-which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly.
• Medical Assessment-includes obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication.
• Biological Sampling Collection/Packaging/Shipping – includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements.
• Case Report Form (CRF) Entries and Management – includes data entry, query resolution in paper and/or electronic CRFs.
• Investigational Product (IP) Management – includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP.
• Develop and/or Maintain Essential Documents – includes study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms.
• Supply Chain Maintenance-Supplies Inventoried, stocking, organizing, and resupply order placed as required. Completed in Envi system.
• Study Coordination- rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits.
• Obtain/Maintain all required training- GCP, IATA,CPR Occasionally help the study coordinators at other offices such as the surgery center.
• Performs other position related duties as assigned.
• Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.

CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS

• BLS certification required, ACLS preferred.
• License and certification as required by state.

KNOWLEDGE | SKILLS | ABILITIES

• Knowledge of medical terminology, healthcare coding systems, and clinics functions.
• Must be able to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work.
• Knowledge of database management.
• Maintain a working knowledge of all assigned study protocols and amendments.
• Excellent verbal and written communication skills.
• Skill in using computer programs and applications including Microsoft Office.
• Delivers exceptional patient service throughout all interactions.
• Ability to work independently and manage deadlines.
• Ability to establish and maintain effective working relationships with patients, colleagues, physicians and the public; successfully manages interactions with challenging or difficult people.
• Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff.

EDUCATION REQUIREMENTS

• Bachelor’s degree in a related field required (eg, biology, psychology, nursing or healthcare).

EXPERIENCE REQUIREMENTS

• Experience with EPIC software preferred but not essential.
• 1-3 years of related experience preferred.

REQUIRED TRAVEL

• Minimal travel required.

PHYSICAL DEMANDS

Carrying Weight Frequency

1-25 lbs. Frequent from 34% to 66%

26-50 lbs. Occasionally from 2% to 33%

Pushing/Pulling Frequency

1-25 lbs. Seldom, up to 2%

100 + lbs. Seldom, up to 2%

Lifting - Height, Weight Frequency

Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%

Floor to Chest, 26-50 lbs. Seldom: up to 2%

Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%

Floor to Waist, 26-50 lbs. Seldom: up to 2%