Clinical Research Coordinator
3 days ago
Rochester
Job DescriptionJob Title: Clinical Research Coordinator Job Description The Clinical Research Coordinator supports and coordinates clinical research studies under the direction of a principal investigator and supervisory staff. This role works closely with multiple departments and research personnel, as well as with research participants, external research centers, and sponsoring organizations, to ensure that studies are conducted efficiently, accurately, and in full compliance with regulatory and institutional guidelines. The position begins with foundational tasks such as kit building, responding to participant communications, and scheduling visits, and progressively expands to include broader responsibilities in protocol coordination, data management, and regulatory support. Responsibilities • Coordinate non-therapeutic clinical research protocols, including minimal-risk studies such as surveys and chart reviews, under the direction of the principal investigator and/or supervisor, ensuring compliance with regulatory requirements and institutional policies., • Assist with complex clinical research studies, including interventional or therapeutic protocols with greater than minimal risk, under guidance, while not holding overall responsibility for these studies., • Screen, recruit, and enroll research participants according to protocol-specific inclusion and exclusion criteria, and maintain accurate documentation of recruitment efforts., • Coordinate and monitor research activities and participant schedules, including arranging study visits, procedures, and follow-up appointments., • Recognize and promptly report adverse events, protocol deviations, and other unanticipated problems to the appropriate parties in accordance with regulatory and institutional requirements., • Collect, abstract, and accurately enter research data into appropriate databases, case report forms, or electronic data capture systems, maintaining data integrity and confidentiality., • Perform administrative and regulatory tasks related to assigned studies, such as maintaining study files, tracking study documentation, and supporting regulatory submissions., • Support protocol development and maintenance by editing and proofing protocol documents, coordinating amendments, and verifying that content meets institutional and federal standards., • Coordinate study logistics, including preparation and management of data collection materials and booklets, and arranging use of clinical research units or other research facilities as needed., • Prepare and submit Institutional Review Board (IRB) applications, amendments, and continuing reviews, and maintain ongoing communication with IRB offices regarding study status changes., • Communicate with study sites, sponsors, and federal or other regulatory agencies regarding study status updates, protocol changes, and reporting requirements., • Participate in additional protocol development activities and complete other assignments related to study conduct as requested., • Initially build study kits, ensuring all required materials and supplies are included and properly labeled for research visits., • Respond to patient and participant emails and phone calls in a timely, professional manner, providing study-related information within the scope of the role and escalating issues when appropriate., • Schedule blood draws and other study-related appointments, coordinating with clinical and laboratory services to ensure accurate and timely specimen collection., • Support specimen processing and handling activities as appropriate to the role and study requirements, following established procedures and safety standards., • Collaborate with investigators, research staff, and other departments to resolve operational issues and promote efficient completion of research studies., • Travel occasionally, as required, to support study activities, meetings, or training.Essential Skills, • Experience in clinical research coordination, including familiarity with research workflows, participant interactions, and study documentation., • Ability to recruit, screen, and enroll research participants in accordance with protocol-defined criteria., • Strong skills in data collection, data abstraction, and accurate data entry for clinical research studies., • Understanding of protocol management, including maintaining protocol documents and implementing amendments under supervision., • Knowledge of regulatory compliance requirements related to clinical research, including adherence to institutional and federal guidelines., • Ability to recognize and appropriately report adverse events, protocol deviations, and unanticipated problems., • Capacity to perform administrative and regulatory duties associated with clinical research, such as maintaining study records and supporting IRB submissions., • Proficiency with medical terminology or completion of a medical terminology course (preferred)., • One (1) year of clinical research experience (preferred)., • High school diploma with at least three (3) years of experience; or an associate’s degree/college diploma/certificate program with at least one (1) year of experience; or an associate’s degree in Clinical Research from an accredited academic institution without experience; or a bachelor’s degree with experience in a clinical or related setting., • Ability to work cooperatively with investigators, supervisors, and research personnel at all levels., • Strong organizational skills to coordinate multiple schedules, visits, and study activities., • Effective written and verbal communication skills for interactions with participants, staff, sponsors, and regulatory bodies.Additional Skills & Qualifications, • Background or exposure to clinical research, clinical trials, or related healthcare settings., • Experience or coursework in biology, chemistry, or related life sciences., • Familiarity with specimen processing, laboratory workflows, or medical laboratory technology., • Experience with medical laboratory instrumentation or medical technologist responsibilities., • Knowledge of Institutional Review Board (IRB) processes, including submissions and status updates., • Experience with protocol deviation reporting and documentation., • Ability to manage multiple tasks simultaneously and adapt as responsibilities expand over time., • Motivation to build a long-term career in clinical research with interest in professional growth and development.Work Environment This role is based in a leading hospital and research environment recognized for excellence in patient care and clinical research. The position offers a Monday through Friday, first-shift schedule, providing a structured workweek. The work involves collaboration with multidisciplinary teams across various departments, as well as interaction with research participants, sponsors, and external research centers. You will work in both office and clinical settings, using standard office technology and research-related systems for data entry, scheduling, and communication. Depending on study needs, you may support activities in clinical research units and laboratory areas where specimen processing and instrumentation are part of the workflow. The organization emphasizes professional growth and offers substantial opportunities to advance your career in clinical research once you have established yourself in the role. Some travel may be required to support study-related activities, meetings, or training. Job Type & Location This is a Contract to Hire position based out of Rochester, MN. Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.