Job Description:
Full-time (40 hrs/wk), Clinical Research Associate position available at a regional medical oncology practice. We are looking for a highly motivated individual to complete data collection and provide administrative support to the NHOH Clinical Trials Research Program in our Manchester location. Responsibilities include but are not limited to:
* In collaboration with the Research Nurse; Maintains trial database, including collecting, and entering data;
* Completes all forms pertaining to protocols, and reporting of questions, discrepancies and violations to protocol investigator and collaborating institutions and companies;
* Organizes monitoring visits;
* Works with clinic management team on additional projects and data analysis.
One to 2 years of experience working in a medical or scientific research setting or comparable technology-oriented business environment is preferred, but we are willing to train the right candidate.
Will require training and occasional coverage in our Concord office. This is an in-person role, not a remote role.
Covid vaccine is required for employment.
SUMMARY: The Clinical Research Assistant / Clinical CRA is responsible for providing administrative/clinical support and data collection for the Clinical Research Dept.
ESSENTIAL DUTIES & RESPONSIBILITIES:
* Refer to required data list from Access weekly to compile needed patient information to complete CRFs for timely submission as required per protocol.
* Call/fax outside offices or use hospital medical records computer system for any patient records needed. Work with NHOH HIS dept as well to obtain same if CRA doesn’t have access to system needed.
* Prepare shadow file and mark in EMR for all new enrollments.
* Ensure all data forms and necessary medical records are complete and submitted timely per protocol guidelines.
* Create a “Protocol Pink Sheet” (study calendar) to inform all departments of needed information. Also update as needed as patient completes phases of treatment and follow-up.
* Add new patients and update visit/test dates to Access database.
* Add new patients to Excel spreadsheet.
* Phone follow-up with patients as needed for long-term follow-up data collection.
* Handle human specimens, by obtaining from lab or pathology department, packing and shipping of specimens in accordance with all safety regulations as needed. Enter data into lab track databases for all cooperative groups and preparing shipping paperwork per protocol.
* Assist Regulatory Coordinator (RC) as needed (filing, IRB submissions, CAPA responses, etc.).
* Participate in on-site and remote internal/external audits (including assisting RC in setting up visits, acquiring auditor user log-ins for EMRs, uploading documents to Veeva or sponsor’s software, assist in navigating EMR, provide documentation, create NTFs, answer CRF queries real-time, finish action items prior to deadline, etc.).
* Participate in on-site and remote monitoring visits (including setting up visits, acquiring monitor user log-ins for EMRs, uploading documents to Veeva or sponsor’s software, assist in navigating EMR, provide documentation, create NTFs, answer CRF queries real-time, finish action items prior to deadline, etc.).
* Assist the Research Nurse with any and all other necessary tasks. This includes phone calls, mailings, filing and miscellaneous data management tasks.
* Encouraged to attend at least one Alliance Group meeting every other year.
* Request CDs of radiological exams to be uploaded electronically to sponsor software.
* Attend study conference calls/webinars/site initiation visits as needed.
* Respond to queries as needed within a timely manner.
* Solicit study questionnaires to patients as needed; including follow-up phone calls to patients to obtain missed items or reminders to complete online surveys when due.
* Teach, consent, and register patients to non-treatment clinical trials.
* Assist in study drug dispensation and accountability under the guidance of a licensed medical professional who’s been trained on the study.
* Assist in collecting/reporting AE/SAE grading and attribution.
* Update Research Dept’s databases and EMR with patient status changes as needed.
* Communicate with protocol coordinators and data managers as needed.
* Follow research patients throughout study lifetime - making sure patients are scheduled appropriately and correct labs and imaging are ordered to follow timelines specified in each protocol. Inform Research Nurse when patients are not scheduled appropriately or if additional orders are needed.
* Inform internal and external financial contacts when patients enroll to studies or study status changes.
* Order study blood/tissue kits, questionnaires, additional administrative supplies, etc. as needed to maintain adequate supplies for the duration of the study. Proactively monitor expiration dates of specimen collection kits monthly.
* Document deviations per study requirements and inform research staff when they occur.
* Print pink sheets & put out for clinical staff as guidance during a patient's office visit.
* Maintain protocol specific training/amendments, GCP, human subject protection, IATA, DARF training, etc.
* Enroll/randomize patients to studies within Rave with supervision/authorization of Research Nurse.
* Maintain log-in credentials as needed for protocol-specific and sponsor websites.
* Work with Radiology departments to ensure proper documentation of target and non-target measurements.
* Coordinate with RadOnc departments to ensure proper documentation & appropriate start/stop dates based on protocol, and digital uploads of all RT Tx.
* Follow proper safety guidelines when interacting with patients and hazardous drugs.
* Be available to assist Research RN in exam room (in tandem with or independently) to obtain toxicity info while patient is seeing provider.
* Assist in re-consent process.
* Maintain studies in EMR – initial onboard of trial, update trial status as needed, add specific arms/branches, add/inactivate staff, etc.
* Assist in clinical study interactions/activities to free up the RNs - geriatric assessments, arm mobilities, collect additional vitals, hip/waist measurements, TUG tests, survival phone calls, administer in-office PROs, etc.
* Review medications and medical history with patient and update EMRs as needed.
* Obtain vitals before, during and post Tx as needed if CRA possesses that skill set.
* May assist in BMBX or other procedures as needed per protocol if CRA possesses that skill set.
* Input financial data into OPEN after completion of study blood/tissue/QOL collection when funding is available/required.
* Maintain study-supplied equipment (tablets/smart phones) for PROs as needed (download software/firmware/operating system/security updates, send data, etc.).
* If certified by SOCRA (or similar group), maintain certification by participating in continuing education.
* Assist Research RN in obtaining study specific requirements/testing (arm/hip/waist measurements, etc.).
* Review and suggest edits to pink sheets created by fellow CRAs.
PHYSICAL, MENTAL AND VISUAL REQUIREMENTS:
Administrative tasks require sitting, walking, bending, reaching, occasional lifting and driving. Most tasks are performed while sitting. This position requires strong keyboarding skills (word processing, spreadsheet, and database management), accuracy and continuous mental and visual attention. Good vision is necessary for accuracy in creating and proofreading documents as well as general composition and design. Telephone communications listening and speaking skills are required for the time spent in this mode of communication. The ability to balance multiple tasks and normal stress associated with the duties and responsibilities of this position are essential requirements in the performance of this job. Works in an office setting and occasionally may work in clinical areas with possible exposure to infectious diseases through airborne transmission or contact with blood or body fluids and hazardous medications.
KNOWLEDGE & SKILLS:
The incumbent must have proficient knowledge in the following areas:
* Demonstrated ability to work as an effective member of an interdisciplinary team.
* Demonstrated skills in critical thinking, problem solving, and ability to make independent decisions.
* Superior attention to detail and organizational skills.
* Excellent customer service and communication skills, both written and verbal.
EQUIPMENT USED:
PC, printer, copy machine, fax machine, calculator, telephone, scanner, study-specific provided equipment (Apple IOS/Android), additional specialized equipment utilized during study (360-degree goniometer, stadiometer, seamstress tape measure, scale, pill counter, etc).
Requirements:
EXPERIENCE/EDUCATION:
College coursework, high school diploma or GED required.
1-2 years experience working in a medical or scientific research setting or comparable technology-oriented business environment is preferred.
Clinical Research Associate Certification eligible after two years of employment and encouraged.
Strong understanding of Microsoft Office product suite.
Clinical skillset from MA/LNA courses is an asset.
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