Clinical Research Manager Jobs in Rochester, MI (NOW HIRING)

Area of experience- Cardiology

Scope of work

The Clinical Research Nurse is responsible for protocol coordination, including research participant recruitment, enrollment, implementation and follow-up of research procedures. The Clinical Research Nurse promotes good clinical practices in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection. The Regulatory Clinical Research Nurse provides regulatory support and guidelines based on Federal Guidelines. Assures compliance with Regulatory guidelines and Beaumont policies (FDA, NIH and HIPAA).

• Participate in subject screening, recruitment, consenting, enrollment, monitoring of treatment, and follow-up procedures.

• Distribute study article, including drug.

• Maintain study article accountability.

• Document all study-related procedures/events and documents, including case report forms or electronic data capture systems.

• Participate in monitoring audits/visits and handle data queries.

• Prepare for and participate in audits by sponsors and external regulators.

• Prepare and/or review complex regulatory documents such as IRB applications, Informed Consent and Authorization documents, complex Amendments, Progress Reports, Adverse Event/Unanticipated Problem Reports, and Protocol Deviations.

• Communicate effectively with the IRB, research participants, research team, principal investigators, sponsors, primary care providers, and ancillary staff to educate on protocol requirements, and to ensure protocol adherence, participant safety, and Regulatory compliance.

• Participate in pre-study preparation, including budget development, regulatory document preparation and problem solving.

• Monitor enrollment goals.

• Practice BH hospitality standards.

• Ensure and participate in appropriate collection, processing and shipping of research specimens.

• Implement quality controls and assurance measures and maintain professional and technical knowledge.

• Protect research participant confidentiality.

• Research participant/family interaction, utilize effective communication skills, incorporate specific age, cultural, or development needs.

Qualifications

• Required Bachelor's Degree in nursing.

• Preferred Current phlebotomy skills.

• Prior medical/surgical clinical experience. Required

• PREFERRED Cardiology experience

• Registered Nurse (RN) - State of Michigan Upon Hire required

• Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates 3 Yrs required Or

• Clinical Research Professional, Certified (CCRP) - AACVPR American Association of Cardiovascular and Pulmonary Rehabilitation 3 Yrs required

• IRB Professional, Certified (CIP) - 3 Yrs required

• At least one Certification from preferred list - Upon Hire required

• Basic Life Support (BLS) - AHA American Heart Association preferred Or

• Basic Life Support (BLS) - ARC American Red Cross preferred

How Corewell Health cares for you

• Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here (https://careers.corewellhealth.org/us/en/benefits-new) .

• On-demand pay program powered by Payactiv

• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!

• Optional identity theft protection, home and auto insurance

• Traditional and Roth retirement options with service contribution and match savings

• Eligibility for benefits is determined by employment type and status

Primary Location

SITE - Research Building - 3811 W 13 Mile Rd - Royal Oak

Department Name

Sponsored Programs Cardiovascular - Royal Oak Hosp

Employment Type

Full time

Shift

Day (United States of America)

Weekly Scheduled Hours

40

Hours of Work

8-4:30

Days Worked

M-F

Weekend Frequency

N/A

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Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.

Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.

An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.

You may request assistance in completing the application process by calling 616.486.7447.