Clinical Research Coordinator - National Harbor, MD

SUMMARY

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the supervision of the clinical Principal Investigator (PI). The CRC reports directly to the Director of Clinical Research. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.

Assists the PI in study feasibility assessments as requested.

Reviews and comprehends the protocol.

Attends investigator meetings as required or requested by the PI.

Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.

Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs and temperature logs.

Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.

Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).

Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.

Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.

Develop advertising and other informational materials to be used in subject recruitment.

Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.

Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol. Prepares the specimens for shipping to laboratory.

Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos. Assures timely completion of Case Report Forms.

Maintains study timelines.

Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. Dispenses study drug to study patients.

Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, and note to file, case report forms, and investigational material accountability forms.

Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

Retains all study records in accordance with sponsor requirements in Regulatory binder

Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.

Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and policies and procedures.

Arranges secure storage of study documents that will be maintained according to the contracted length of time, whichever is longer.

KNOWLEDGE, SKILLS, AND ABILITIES

Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties

Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned

Ability to practice confidentiality and follow HIPAA regulations with patient information

Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization

Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary

Knowledge of medical terminology and ability to use appropriately

Ability to manage time efficiently, prioritize, multi-task, and adapt to change

Ability to maintain high level of accuracy in all documentation and in the performance of all job duties

Ability to perform the essential job duties within the scope of education and training

Skilled in typing/keyboarding; skilled in using computers

PROFESSIONALISM

Project a professional manner and image, including proper workplace attire and grooming standards; exhibit professional conduct at all times.

Adhere to ethical principles and core ADCS values; follow all ADCS policies

Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity

Demonstrate initiative and responsibility for actions

Work as an effective team member

Maintain a strong record for attendance and punctuality in arriving at work

Enhance skills through continuing education

EDUCATION

Bachelor's degree in a related field preferred but not required

LICENSURE/CERTIFICATION REQUIREMENTS

Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP preferred

Phlebotomy Certification preferred

Good Clinical Practice (GCP) preferred

International Air Transport Association (IATA) Training preferred

LANGUAGE/COMMUNICATION REQUIREMENTS

Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals

Ability to write routine reports and correspondence

Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding

Ability to practice professional telephone etiquette and techniques on all calls

MATHEMATICAL SKILLS

The ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

REASONING ABILITY

Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.

WORK ENVIRONMENT AND CONDITIONS

Work is performed in offices and occasionally research sites. Involves frequent telephone and in-person contact with staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work required. Occasional travel required.

COMPENSATION

-401K/PTO/Vacation/Benefit Packages

NOTE: This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.