Clinical Research Coordinator Assistant

divh2Clinical Research Coordinator Assistant/h2pEnvisioning and implementing a holistic approach to neurological treatment is our goal, and our unique research and powerful solutions illuminate the path toward greater innovations for the future of healthcare. Patients and families seeking effective surgical procedures, rehabilitation, and neurological treatment can trust in our highly skilled and renowned surgical team. As we provide comprehensive services at our state-of-the-art inpatient and outpatient facilities, we remain driven by our basic oath to help patients heal while providing a genuine, human touch./ppThe Clinical Research Coordinator (CRC) Assistant will work collaboratively with a multi-institutional team. The CRC assistant will support the CRC, administrative staff and principal investigators, assist the communications between sponsor and institute, oversee details of clinical studies and ensure compliance with study review board and clinical research regulations. The CRC assistant can be part of multiple research projects and should have the ability to multi-tasks./ppDuties:/pulliDevelops and maintains knowledge and proper skills to comply with the protocol, federal regulatory requirements and internal SOPs/liliPrepare and attend study meetings/liliPerforms study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site/liliProactively develops and executes recruitment plans that meet and exceed enrollment goals/liliMaintains proper skills to update databases, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment/liliCreates and updates source documents/progress notes, and collects study data via source documents/progress notes as required by the protocol/liliPerforms technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol/liliPerforms continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials/liliDocuments laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events/liliBuilds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants/liliDispenses study medication at the direction of the Investigator/liliMaintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits/liliEnters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor/liliAddresses all queries or data clarifications within the time period specified by the sponsor/liliMeets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in a timely manner during these visits/liliReports protocol violations and significant deviations to the CRCs and the investigators/liliEstablishes relationships with participants, and participates through ongoing patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process/liliAssists other staff members at the site as determined by the needs and priorities of the organization and as time and abilities permit/liliAnticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement/li/ulpRequirements:/pulliEducation Degree in health-related field/life science with minimum one year experience in clinical research/liliClinical research certification GCP and IATA certification are required (or willing to obtain them within the first month of assignment)/liliBasic Skills: Medical terminology and knowledge of disease processes/liliWorking knowledge of clinical research design and regulatory requirements/liliExcellent interpersonal, verbal, and written communication skills./liliOrganized and detail-oriented individual./liliComfortable working in a team environment/liliProficient in spreadsheets and clinical research software./liliUnderstand clinical procedures, regulations and be an excellent team player working with physicians, nurses, non-clinical, laboratory and ancillary staff/liliCapability to meet data deadlines and maintain confidentiality/liliAbility to travel to INSIGHT local offices when needed/liliBehavioral Competencies Ability to relate and work effectively with others. Demonstrated skills in verbal and written English communications for safe and effective patient care and to meet documentation standards. Proven excellence in patient safety and care. Friendly, empathetic respectful. Reliable in work results, timeliness attendance. Ability to relate to and work effectively with a wonderfully diverse populace. Able to work in a fast-paced, and stressful environment while maintaining positive energy. Able to work under pressure and in situations that benefit from patience, tact, stamina and endurance. Detailed oriented, conscientious and committed to precision in work results. Committed to contributing to a positive environment, even in rapidly changing circumstances. Is aware of standards and performs in accordance with them. Able to provide eligibility for employment for any U.S. employer./li/ulpBenefits : Paid Sick Time - effective 90 days after employment. Paid Vacation Time - effective 90 days after employment. Health, vision dental benefits - eligible at 30 days, following the 1st of the following month. Short and long-term disability and basic life insurance - after 30 days of employment. Insight Employees are required to be vaccinated for COVID-19 as a condition of employment, subject to accommodation for medical or sincerely held religious beliefs. Insight is an Equal Opportunity Employer Values Workplace Diversity!/p/div