Innovo Research is a provider-sponsored, provider-led network of high-performing Accountable Care Organizations (ACOs) that utilize clinical research as part of their population health strategy. Our integrated approach supports both the triple aim aspirations of our partner ACOs as well as their research interests. We also add value to the pharma industry by assisting with the pragmatic design of future trials and observational study capabilities once their therapeutic is in the market. In addition, we can follow cohorts of patients throughout the various stages of development and deployment of the therapeutic. The results are better outcomes for patients, lower cost for the healthcare industry, higher patient engagement, and a diversified revenue source for our partner ACOs.
At Innovo Research, our mission is to promote clinical research as a patient care option by demonstrating its value to all stakeholders, while dramatically reducing the time it takes to develop new therapeutics. Please visit our website at www.innovoresearch.com.
The Senior CRC/Site Manager will work closely with Principal Investigators and clinical research teams to coordinate the daily operations of clinical research studies and oversee clinical research staff performing clinical functions at the designated Innovo Research partner site. Reporting will include accountability to the Sr. Director of Clinical Operations, PI, and others, as necessary. You are accountable for conduct of clinical research/trials in accordance with Good Clinical Practices (GCPs), applicable regulations and guidelines, and Standard Operating Procedures (SOPs). This individual will play a key role in facilitating the training and support of local physicians, and research staff on protocol requirements, GCP and other applicable regulatory requirements. The Senior CRC/Site Manager will be responsible for making sure that all clinical research activities are efficiently executed, conducted in a professional manner that is compliant with all human research subject regulations.
- Oversee/assist with mentoring and training clinical research staff.
- Maintain frequent communication with research assistants and research coordinators regarding enrollment and tasks, as assigned.
- Perform clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educates family and contributes to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
- Liaises with agencies, pharmaceutical companies, laboratories, vendors, equipment and supply companies as needed; oversees availability of supplies and/or equipment for studies.
- Directly coordinate regular research meetings.
- Assist the principal investigator with the management of day-to-day operations related to clinical research and subject care as necessary.
- Manage multiple concurrent trials - screening, recruiting and enrollment, perform patient/research participant scheduling, coordinate protocol related research procedures, study visits, and follow—up, collect patient/ research participant history, collect and maintain source documentation, perform data entry and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events.
- Develop strong working relationships and maintain effective communication with study team members.
- Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
- Completes all protocol related training and adhere to IRB approved protocol(s)
- Support the collection and review of required essential study documents and reports.
- Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging and laboratory handling manuals, etc.).
- Assist in the informed consent process of research subjects.
- Support and advocate for the safety of research subjects.
- Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities.
- Collect, process and ship laboratory specimens.
- Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines.
- At least 3-5 years of experience coordinating clinical trials, including the activities listed above
- BS/BA in Life Science or related discipline. CCRC certification a plus.
- Previous GCP training and certification required and working knowledge of current ICH GCP guidelines and applicable regulations. Experience in a clinical setting a plus
- Demonstrated ability in positive relationship building
- Previous experience with training and mentoring other clinical research professionals a plus
- Strong interpersonal skills with attention to detail a must. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
- Strong organization/prioritization skills for the management of multiple concurrent projects.
- An understanding of Regulatory and Central/Local ethic submission processes
- Ability to manage multiple competing priorities within various clinical trials
- Excellent verbal and written communication skills required
- Ability to work independently, prioritize and work with a matrix team environment is essential
- Ability to travel for Clinic activities, attend investigator meetings or vendor visits/audits, as required.