Senior Clinical Research Coordinator

Work closely with Principal Investigators and clinical research teams to coordinate daily operations of clinical research studies and oversee clinical research staff performing clinical functions at the designated Innovo Research partner site. Ensure all clinical research activities are efficiently executed and conducted in a professional manner compliant with human research subject regulations. Cardiology experience is preferred.

Responsibilities

• Assist with mentoring and training clinical research staff.
• Perform clinical functions (e.g., phlebotomy, monitoring vital signs on study participants) when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/exclusion criteria.
• Liaise with agencies, pharmaceutical companies, laboratories, vendors, equipment, and supply companies as needed; oversee availability of supplies and/or equipment for studies.
• 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; maintain source documentation; perform data entry and query resolution; prepare IRB submissions, updates, modifications, continuing reviews, and reportable events.
• Develop strong working relationships and maintain effective communication with study team members.
• Complete 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).
• 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.
• Perform all additional duties as assigned.

Requirements

• At least 3-5 years of experience coordinating clinical trials, including the activities listed above.
• Cardiology experience preferred.
• BS/BA in Life Science or related discipline.
• Certified Clinical Research Coordinator (CCRC) certification preferred.
• Previous GCP training and certification required; working knowledge of current ICH GCP guidelines and applicable regulations.
• Experience in a clinical setting.
• Demonstrated ability in positive relationship building; previous experience with training and mentoring other clinical research professionals is a plus.
• Strong interpersonal skills with attention to detail.
• 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.
• Understanding of Regulatory and Central/Local ethics submission processes.
• Ability to manage multiple competing priorities within various clinical trials.
• Excellent verbal and written communication skills.
• Ability to work independently, prioritize, and work in a matrix team environment.
• Ability to travel for Clinic activities, attend investigator meetings, or vendor visits/audits as required.

Benefits

• Competitive salary
• Health Insurance
• Dental Insurance
• Disability Insurance
• Life Insurance
• Paid Time Off
• Vision Insurance

Schedule

• Full-time, exempt position (not eligible for overtime pay).
• Expected to work 40 hours a week.
• Occasional evening and weekend work may be required as job duties demand.
• In-person work expected due to the nature of the position.

Working Conditions

This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. Routinely uses standard office equipment such as computers, phones, and scanners. Frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment.

• Varied activities include standing, walking, reaching, bending, and lifting.
• Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination.
• Requires standing and walking for extensive periods of time.
• Occasionally lifts and carries items weighing up to 50 pounds.
• Requires corrected vision and hearing to normal range.