Senior Clinical Research Coordinator

Ann Arbor, MI - USA

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

OVERVIEW

This role will coordinate research in an exciting new environment with the full backing of a new type of research architecture and a top-tier technology team challenging the paper-heavy old-school way that studies are run. This role will require the desire to learn and grow rapidly and include the opportunity to help spearhead on-site efforts for Topographys partner healthcare groups. This role will be evaluated on provider success patient experience protocol management and adherence and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air and where independent problem solving is a daily need. You will need to lead with empathy for patients and care deeply about creating new access to clinical research in communities across the country.

KEY RESPONSIBILITIES

Act as senior study coordinator to execute trials conducted within physician practices including but not limited to:

a. Visit preparation activities

b. Visit follow-up activities

c. Supply and inventory management

d. Third party vendor management

Conduct patient recruitment and enrollment of eligible patients.

Lead patient study visits which may also include clinical and lab procedures such as ECG phlebotomy vitals signs and body measurements laboratory processing etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity

Provide high quality source data capture and documentation

Support study start-up and planning including PSVs and SIVs

Support IRB submission and correspondence

Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process

IP management dispensation and accountability

Adverse Event management tracking and follow-up

Data entry to CRF/EDC and query resolution in a timely manner

Support study close-out including COVs

Protocol deviation tracking reporting and reconciliation

Train and mentor junior research staff

Using and helping improve Topographys proprietary tool set

Data Quality-understand and comply with all regulations policies and guidelines applicable to clinical research including our SOPs

Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation

Conduct Quality Control activities including routine QC checks during and following study visits

Any other duties assigned by manager

MINIMUM QUALIFICATIONS

Bachelors degree or equivalent combination of training and experience

Ability to be on site 5 days a week in Chevy Chase MD

5 years of experience as a Clinical Research Coordinator Research Assistant or other similar role

5 years of experience independently coordinating studies from study startup to close out

5 years demonstrated track record of delivering clean data and a high-quality patient experience

Expert knowledge of FDA regulations and ICH/GCP guidelines

Strong communication skills teamwork cooperation self-awareness and flexibility

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Senior IC

OVERVIEWThis role will coordinate research in an exciting new environment with the full backing of a new type of research architecture and a top-tier technology team challenging the paper-heavy old-school way that studies are run. This role will require the desire to learn and grow rapidly and inclu...