Position Details
- Schedule: Full-time (40 hours/week)
- Location: Hybrid
- Salary Range: Starting range $60,153.60 - $69,180.80/year (Where an applicant may fall on the salary range will vary based on a variety of factors, including but not limited to experience & education)
Benefits
- Health Coverage: Medical, Dental & Vision Insurance
- Retirement: 401(K) with Company Match, Profit Sharing
- Time Off: Generous PTO, Holiday Pay, Floating Holiday
- Disability Coverage: Short & Long-Term Disability
- Family Support: Paid Leave and Disability
- Performance Incentive: Discretionary Bonus Based on Company, Department, and Individual Goals
Key Responsibilities
General Administration:
- Coordinate with PI and Department Manager to ensure that clinical research and related activities are performed in accordance with Federal regulations, GCP, MNGI policies and procedures, and sponsoring agency policies and procedures.
- Assist 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, and execution of research plan. Maintain documentation of training.
- Assist PI to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations and sponsoring agency policies and procedures.
- Coordinate and facilitate monitoring and auditing visits. Notify appropriate organizational and sponsor agency officials of external audits by FDA and sponsors.
- Collaborate with PI and institution to respond to any audit findings and implement approved recommendations.
Protocol Preparation & Review:
- Review and comprehend the protocol.
- Attend investigator meetings as required or requested by the sponsoring agency.
- Prepare other study materials as requested by the sponsor. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Prepare applicable submission forms and submits updated documents.
- Create training materials for research PIs, Sub-Is and staff and facilitate documentation of training completion.
- Establish and organize study files, including but not limited to the study specific source documentation, the regulatory binders and other materials.
Conduct of Research:
- Review and develop a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Assist PI in communication of study requirements to all individuals involved in the study. Provide appropriate training and tools for study team members. Document date of training and signatures of study personnel trained on study specific training log.
- Work with the PI and Research Recruitment Specialist to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
- Conduct and participate in the informed consent process including interactions with research participants, answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places. Assure that amended consent forms are appropriately implemented and signed.
- Collect and review medical records for participants prior to randomization, as needed for safety reporting, and as requested by investigators.
- Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion in the study.
- Complete and document intake and protocol-specific procedures.
- Manage, dispense, and collect investigational product. Assess compliance and provide counseling.
- Complete and document investigator orders.
- Oversee recruitment activities and coordinate recruitment plan with Research Recruitment Specialist to ensure enrollment goals are met.
- Coordinate and schedule participants’ tests and procedures.
- Collect data as required by the protocol. Assure timely completion of Case Report Forms and resolution of data queries.
- Maintain comprehensive knowledge of protocol and study timelines.
- Maintain study supplies.
- Facilitate and work directly with the PI to manage the administration of investigational products to research patients as stated in the protocol and/or the MNGI policy regarding Investigational Product.
- Complete study documentation and maintains study files in accordance with sponsor requirements and MNGI policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Retain all study records in accordance with sponsor requirements and MNGI policies and procedures.
- Maintain effective and ongoing communication with sponsor, CRO, research participants and PI during the study.
- As requested: Prepare, submit, and maintain timely and accurate initial, continuing and final regulatory documents to the IRB, sponsors and state or federal regulatory offices as necessary, including but not limited to: Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s and informed consent documents.
- Ensure all required documentation and training is completed and filed prior to initial patient recruitment.
- As requested by Department Manager: Prepare, maintain, and provide oversight on all research-related regulatory documents. Prepare, submit, and maintain IRB applications for protocol revisions or amendments, changes in subject population, funding, recruitment procedures, site changes, or changes in the informed consent for IRB approved protocols as required by the federal regulations and internal policy. Ensure that all documents are complete and that submission packets meet the IRB's requirements prior to submission.
- Responsible for appropriate and timely reporting of protocol deviations and safety events to the sponsor and IRB.
- Maintain comprehensive knowledge of reporting requirements of multiple IRBs.
- Ensure documents requested by sponsors and IRBs are signed and returned in a timely manner.
- Assist Research Regulatory Assistant in preparing regulatory binders and documents for monitoring visits and audits. Meet with sponsor monitors to ensure accuracy of site files.
Project Closeout:
- Submit closeout documents to the IRB accurately, timely and in accordance with sponsoring agency policies and procedures.
- Arrange secure storage of study documents that will be maintained according to MNGI policy or for the contracted length of time, whichever is longer.
- Protected Health Information
- Adhere to and support all Federal regulations and MNGI policies and procedures instituted to safeguard protected health information (PHI).
- Any and all other duties as assigned
Essential Functions: In order to perform this job successfully, an individual must be able to perform each essential function satisfactorily and regular attendance is required. The responsibilities listed below are representative of the primary essential functions required; additional duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- Bachelors degree in science-related field preferred
- Two years of experience as a Clinical Research Coordinator with experience managing device or pharmacology trials
- One to two years’ experience with an electronic health record is preferred
Certifications/Licenses:
- CCRC (Certified Clinical Research Coordinator) is preferred
Qualification Requirements: The qualifications listed below are representative of the knowledge, skills, and/or abilities required to perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities
Required Knowledge
- Microsoft Office applications
- Medical terminology
Required Skills
- Compassionate patient care
- Active listening
- Problem solve, prioritization, and critical thinking
- Attention to detail and organization
Key Abilities
- Multitask
- Communicate effectively verbally and in writing
- Work independently as well as in a team environment
- Type proficiently and accurately
Physical Requirements: The physical requirements described here are representative of the physical demands required by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to walk, sit, stand, reach overhead, and bend to the floor. The employee is regularly required to talk and hear. The employee is required to use dexterity of hands and fingers to operate a computer keyboard, mouse, and other office equipment. Specific vision abilities required by this job include close vision and ability to adjust focus. The employee may be required to lift and transport items up to 15 pounds occasionally. Employees may be required to travel to other company locations due to staffing and training needs.
Working Environment: The working environment described here is representative of the setting which an employee may encounter on the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee works in a clinical environment and may be exposed to hazardous chemicals or conditions including exposure to blood or other body fluids. Appropriate Personal Protective Equipment (PPE) and training will be provided. The employee is exposed to a computer monitor daily. The employee may be required to travel by automobile and exposed to changing weather conditions while performing the duties of this position. While performing the duties of this position, the employee must be alert to conditions that may impact the safety of patients, employees and visitors.
This job description reflects management’s assignment of key responsibilities; it does not prescribe or restrict the tasks that may be assigned.
MNGI Digestive Health provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
It is the policy of MNGI Digestive Health to comply with all federal and state laws concerning the employment of persons with disabilities and to act in accordance with regulations and guidance issued by the Equal Employment Opportunity Commission (EEOC). Furthermore, it is the company policy not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment
MNGI’s Culture of Caring
We are caring people, caring for people - working with Compassion, Teamwork, and Integrity
- Compassion: being empathetic and considerate of the needs of our patients and caregivers
- Teamwork: Being accountable for actions, supporting each other in meeting the needs of our patients, and respecting the voice/opinions of others assuming good intent.
- Integrity: Demonstrating honesty, trustworthiness, and transparency whenever you interact with patients or each other.
Preferred
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2 year(s): Clinical Research experience
Preferred
Preferred
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Cert Clinical Research Co
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
