Lead Clinical Research Coordinator - Hospital Internal Medicine Research

Job Description

• Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
• Collaborates with research team to assess feasibility and management of research protocols.
• Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports.
• Screens, enrolls, and recruits research participants.
• Coordinates schedules and monitors research activities and subject participation.
• Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
• Manages, monitors, and reports research data to maintain quality and compliance.
• Provides education/training for others within the department and serves as a first line resource for team members.
• Performs administrative and regulatory duties related to the study as appropriate.
• Performs administrative functions to support work unit.
• Some travel may be required.
• Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements.
• Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
• Participates in other protocol development activities and executes other assignments as warranted and assigned.

***After the initial training period, the selected candidate may be able to work remotely at times, if they wish. The rest of their time will be on-site.***

***The hired individual must live within a reasonable driving distance of the Rochester, Minnesota campus.***

***Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.***

Qualifications

• HS Diploma with at least 6 years of clinical research coordination/related experience OR
• Associate's degree/college Diploma/Certificate Program with at least 4 years of clinical research coordinator/related experience, Associate's in Clinical Research from an accredited academic institution without experience OR
• Bachelor's with at least 2 years of experience in clinical research/related experience.

Additional Qualifications

• Experience coordinating FDA regulated clinical trials is preferred.
• Experience working with patients who have a rare disease is preferred.
• Graduate or diploma from a study coordinator training program is preferred.
• One year of clinical research experience is preferred.
• Medical terminology course is preferred.

License or Certification

• SoCRA or ACRP certification preferred.

About Us

Why Mayo Clinic

Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You'll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.

Benefits Highlights

• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.

About the Team

Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.

Affirmative Action and Equal Opportunity Employer

As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.