Clinical Research Coordinator I

JOB SUMMARY

Coordinates with the Principal Investigator to ensure that the Clinical Research and related activities are performed in accordance with federal regulations.

RESPONSIBILITES

• Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations
• Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Attends investigator meetings as required or requested by the PI.
• Collaborates with the PI to prepare IRB/HRPO 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, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials
• Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• 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.
• 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.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Coordinates participant tests and procedures
• Collects data as required by the protocol. 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 and/or Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and site policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Retains all study records in accordance with sponsor requirements and site policies and procedures.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and sponsoring agency policies and procedures.
• Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management
• Arranges secure storage of study documents that will be maintained according to the site’s policy or for the contracted length of time, whichever is longer
• Assists the Principal Investigator in submission of accurate and timely closeout documents to sponsor and IRB
• Coordinates appropriate and timely payments to participants
• Assists Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training
• 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.
• Adheres to and supports all Federal regulations and site policies and procedures instituted to safeguard protected health information (PHI).
• Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the sponsor and IRB.
• Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety training in accordance with Federal, State, and local regulations
• Complete drug accountability logs per patient (receivable and returnable)
• Maintains IATA certificate for blood drawing and shipping of specimens

WORKING CONDITIONS

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.

KNOWLEDGE SKILLS AND ABILITIES REQUIRED

• Qualifications include:
• Ability to read, write, and interpret the English & Spanish language.
• Coordinating Skills - Minimum of 2-5 years of research experience
• Technical Assessment skills
• Computer skills: EDC experience with RAVE, Oracle, Trial master, IRT, Bracket
• Demonstrates strong analytical, problem solving skills
• Strong written and verbal communication skills.
• Detail oriented, good organizational traits.
• Self-motivated
• Medical assistant certificate preferred
• Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
• Pool Position - Ability to work various shifts, including nights & weekends as required.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far.
• Ability to identify and distinguish colors.
• Hazards:
• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens