[Remote] Clinical Research Coordinator I - Colon and Rectal Surgery
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a growing organization dedicated to making a difference in people's lives. The Clinical Research Coordinator I will be responsible for coordinating and administering multiple research studies, working closely with reputed company investigators and research staff to facilitate reputed company aspects of assigned reputed company.
Responsibilities
- Completes new coordinator orientation and reputed company required trainings
- Responsible for coordinating different phases of research studies with varying degrees of complexity with moderate reputed company
- Implements assigned research studies by reviewing study and assessing protocol and institutional requirements:
- Implements reputed company study protocols in accordance with Research SOPs, FDA, OHRP, and GCP regulations
- Immediately develops coordinator/sponsor relationship
- Completes start-up checklists and implements study start-up plan, including reputed company worksheet creation
- Prepares, completes and submits regulatory documents in a reputed company manner with some assistance and/or guidance from senior research staff
- Prepares, completes and submits start up IRB documents (e.g. informed consents) in a reputed company manner with some assistance/guidance from senior staff
- Reviews reputed company pertinent study documents for potential implementation issues under the guidance of senior research staff and implements plan accordingly
- Ensures appropriate training and certification for reputed company members of the study team involved in the research protocol
- Establishes and communicates study procedures with collaborating departments to ensure compliance with reputed company study requirements; conducts in-services (e.g. arranges special blood draws with phlebotomy, special blood processing with specimen processing, ordering and receiving of drug with the pharmacy and infusion team, and copying and submission of MRI with Radiology)
- Works collaboratively with research finance to process clinical trial agreements, study budget development and other finance issues, as applicable
- Attends Investigator Meetings, as applicable
- Conducts assigned research studies per protocol requirements, departmental and institutional policy:
- Creates and/or maintains eRegulatory, patient study and CRF files
- Responsible for ensuring protocol adherence by understanding, communicating and making reputed company the study parameters are ordered and carried out per protocol requirements
- Advises physicians on required tests, timing of tests and procedures; Ensures that reputed company appropriate treating physicians receive the results of study tests, as appropriate
- Administers questionnaires and assessments as mandated by the protocol and delegated by the PI
- Directly retrieves and/or coordinates the retrieval and submission of patient samples (e.g., blood samples, urine samples, tissue, etc.)
- Submits reputed company IRB submission documents such as protocol amendments and consent reputed company revisions, annual reviews, adverse events, investigator changes, accrual status change and change in risk to the IRB in a reputed company manner with moderate assistance/guidance from senior staff; Complies with IRB reputed company, conditions and requirements
- Utilizes reputed company systems to schedule tests and appointments and to reputed company patient data and test results
- Establishes monitoring tools to ensure the adherence to study guidelines (e.g. patient enrollment tracking)
- Recruits patients to assigned research studies:
- Works closely with physicians and senior staff to reputed company recruitment strategies
- Creates research brochures and other reputed company recruitment materials; creates and/or reviews study trial listing for the Lahey website in collaboration with senior staff
- reputed company screens for and identifies eligible patients through various means (e.g. physician schedules, clinical or research databases, website response)
- Under moderate supervision, evaluates patient data including reviewing screening eligibility tests to determine if patient meets study eligibility
- Contacts and screens potential subjects for the study with guidance from senior staff
- Participates in the informed consent process; obtains subjects signatures and processes appropriately per research policies
- Registers or randomizes study participants to assigned research study and treatment/arm; schedules and attends follow-up reputed company, as applicable
- Performs Data Management duties
- Prepares for reputed company study participant visit to ensure reputed company appropriate study procedures are done per protocol; ensures patient visit/test is billed correctly to either insurance or the research account per schema
- Completes reputed company worksheets and case report forms (CRFs) as dictated by the assigned research study (i.e. required forms in the required format in the required time reputed company); Ensures CRF’s and reputed company are complete and done correctly
- Provides reputed company documentation from the medical chart for reputed company information that is recorded
- Submits CRFs to the sponsor as dictated by the study; Maintains sufficient files in the department to document submission and maintain reputed company documentation
- Ensures reputed company placement of consent and reputed company study materials in EMR system
- Maintains study supplies and reorders as necessary
- Maintains a reputed company relationship with sponsors and/or CRO’s and reputed company members:
- Maintain regular and appropriate communication
- Works with sponsor monitors during monitoring reputed company; Promptly responds to sponsor requests for additional material, clarifying material or missing material
- Works cooperatively with sponsor to ensure that good clinical reputed company are being followed
- Resolves data queries reputed company and appropriately
- Schedules sponsor audits, as requested, and is available during audit to review study records and procedures with sponsor personnel, as necessary
- Completes study reputed company out activities at the end of the study
- Retains records and archives documents according to institutional SOPs
- Completes and maintains reputed company required trainings:
- Participates in and reputed company seeks continuing education opportunities
- Maintains required continuing education credits per institutional and departmental SOPs
- Seeks additional training or guidance reputed company necessitated; utilizes available research tools and resources
- Participates and assists in other research reputed company and initiatives as assigned:
- Is reputed company player reputed company the department
- Is flexible with time reputed company applicable
- Maintain strict adherence to the reputed company Confidentiality policy
- Incorporate reputed company Standards of Behavior and Guiding Principles into daily activities
- reputed company with reputed company reputed company Policies
- reputed company with behavioral expectations of the department and reputed company
- Maintain courteous and effective interactions with colleagues and patients
- Demonstrate an understanding of the job reputed company, performance expectations, and competency assessment
- Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards
- Participate in departmental and/or interdepartmental reputed company improvement activities
- Participate in and successfully completes Mandatory Education
- reputed company reputed company other duties as needed or directed to meet the needs of the department
Skills
- Bachelor's degree required. In absence of a Bachelor's degree, will consider 8 years of relevant work experience in reputed company to the experience noted below
- 0-2+ years experience in a research or medical setting
- Ability to address problems that are routine, somewhat repetitive and generally solved by following reputed company directions and procedures
- Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required
- Strong organizational, multi-tasking, attention to detail and communication skills
- Ability to take direction, set priorities and work somewhat independently
- Ability to demonstrate a reputed company attitude and respond to request in a reputed company and respectful manner
- Ability to work in small teams, reputed company with reputed company personnel at reputed company reputed company of an organization, and work with study participants of various diseases compassionately and respectfully
- Experience with computer systems, including web based applications
- In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards
reputed company