Clinical Research Assistant (Spanish speakers encouraged to apply!)

Our growing company is currently searching for a Clinical Research Assistant to join our friendly and patient-centric team. Spanish speakers are encouraged to apply! The perfect candidate will be experienced in clinical trials, a team player and have an interest in working in a multicultural environment.

Responsibilities

The Clinical Research Assistant is responsible to assist in multiple research studies and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP)

Job Duties Include:

• Develop and maintain a professional and educational relationship with sponsors, CROs, monitors, investigators, and staff.
• Maintain in-date regulatory documents via and training records of study staff and investigators in accordance with applicable regulations.
• Prepare documents for submission to relevant authorities as needed.
• Track progress of submissions throughout their life cycle
• Assist the PI and other designated research staff in the preparation, submission, and
• maintenance of all the study-related regulatory documents
• Complete all the data entry with accuracy and in a timely manner
• Prepare and participate in sponsor monitoring visits
• Coordinate all aspects of the assigned clinical research trials
• Assist to process and ship lab specimens per protocol requirements
• Review assigned trials for adherence to the compliance guidelines set forth by
• IRBs/Regulatory agencies
• Maintain regulatory binders in accordance with sponsor specification and general industry standards
• Coordinate with the PI regarding the maintenance of regulatory IRB and other
• documentation and procedures

Additional Requirements

· Responsible for daily maintenance of ISFs

· IRB communication, filing, submissions (initial reports, closure reports, deviations, site changes submissions), reporting in a daily basis

· Email correspondence with the site (SCs, PIs, sub-Is, other staff), filing various documentation

· Prepare ISFs for IMVs, COVs, - resolving action items and assisting with questions from the monitors

· SIVs – initial submissions, collecting initial packet documents

· Using variety portals

· Following company SOPs, using working practices and reference documentation

· Assist with procedures for initiation, execution and termination (close out visits)

· Assist with supporting study startup process, collecting and providing Sponsors with regulatory documents (1572, FDFs, signature pages, other forms), interaction with PIs, research, clinical and administrative staff, provide back up and updates to the study team, attending SIVs, creating and filing training for staff, DOA logs

· Post initial IRB submissions - CRRFs, modifications, translation requests, IRB queries, termination reports

· Maintain ISF binders including complete forms, logs, filing CV, MLs, 1572 forms,
FDFs, signature pages, IRB approvals, Protocols, IBs, ICFs, ICFs tracking log,
safety portals correspondence, and lab documentation

· Attending daily department meetings, following deadlines, conference calls, adherence to the company SOPs

· Ensure the protection of study patients and compliance with the Good Clinical Practice ICH/GCP

· Assist to screen subject for eligibility, documenting eligibility of each potential participant, assist PI to enroll patients using specific inclusion / exclusion criteria

· Conduct daily trial visits according to the protocol, schedule patient`s visits, phone calls

· Collect and maintain accurate study data, complete CRFs as instructed, ensuring that CRFs are completed prior to monitoring visits, IWRS randomization

· Report serious adverse events and answer raised queries

· Maintains source and essential documentation

· Review ICFs, perform investigational product accountability, complete IP, temperature logs etc.

· Compliance with good clinical practices ICH/GCP regulations, specific requirements of the Sponsor/CRO and regulatory authorities

Education and Qualifications

• High School Diploma or equivalent required.
• Associates degree in a clinical or scientific related discipline required.
• Bachelor's degree preferred.
• One (1) year previous experience as a clinical research assistant for pharmaceutical phase II or III trials required.
• Previous GI trials experience preferred.
• Clinical experience in an office or hospital setting.
• Research experience or equivalent.
• Must maintain current licensure and/or certification.
• Understanding of clinical research documentation standards.
• Knowledge of equipment, supplies, and materials needed for medical treatment.
• Understanding of basic laboratory procedures including phlebotomy, preparation, and screening.
• Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails.
• Understanding of Code of Federal Regulations for Human Subjects.
• Certified or able to certify in GCPs and HSP.
• Periodic local travel to other practice locations on an as-needed basis.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to speak and hear.

This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35 or more.

Work Environment: This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids.

Occasional exposure to communicable diseases and biohazards. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required.

Job Type: Full-time

Pay: $17.00 - $20.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Medical specialties:

• Gastroenterology

Physical setting:

• Clinic

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Associate (Required)

Experience:

• Clinical research: 1 year (Preferred)

Language:

• Spanish (Preferred)

Ability to Commute:

• Nashville, TN 37211 (Required)

Work Location: In person