Study Start Up Manager

Care Access; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

A leading company in clinical research is seeking a Study Start Up Manager to facilitate site activation and manage the start-up process for clinical trials. This role involves collaborating with various teams to ensure smooth operations and adherence to industry regulations. Candidates should have significant clinical research experience and strong project management skills, along with a commitment to fostering a diverse and inclusive environment.

Benefits

Comprehensive benefits including PTO

Paid medical/dental/vision

401k

Disability and life insurance

Culture of growth and inclusion

Qualifications

• 3+ years of clinical research experience, including 1+ year of study start-up activities.
• Proficiency with project management skills and ability to work independently.
• Strong communication and interpersonal skills.

Responsibilities

• Lead site activation and manage communications with clients.
• Collect and interpret information for site evaluation visits.
• Support sites through the Site Evaluation and Initiation Visits.

Skills

Communication

Interpersonal skills

Project management

Clinical research processes

GCP knowledge

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office Suite

Job description

Join to apply for the Study Start Up Manager role at Care Access

What We Do
Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.

Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview
Care Access Study Start Up Managers play a critical role in facilitating the start-up activities needed to select and activate studies at sites within Care Access. This role supports the selection and start-up process for our sites by leading cross-functional groups across the global organization to complete successful pre-site visits and accelerate site activation. This role will follow the Care Access study start-up processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements.

Key Responsibilities

1. Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits.
2. Oversee the execution of Site Activation, site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.
3. Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent.
4. Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent.
5. Manage communications and expectations with clients (Sponsor and/or CRO).
6. Provide guidance and oversight during the initial start-up phase as part of the study start-up team.
7. Collaborate with onsite staff to address questions and ensure smooth start-up activities.
8. Transition all information gained during start-up to relevant teams and sites.
9. Partner with other Care Access teams for related processes at the appropriate SSU milestone.
10. Establish timelines and communicate needs with internal and global stakeholders.
11. Support sites throughout activation, including risk assessment and mitigation.
12. Manage vendor requirements and escalation processes.
13. Track and report on SSU submission and approval timelines.

Scope Of Role

• Work is performed under general supervision.
• No direct reports.

Physical & Travel Requirements

• Remote work environment, with less than 10% travel, occasional planned travel may be required.

Qualifications & Skills

• At least 3+ years of clinical research experience, including 1+ year of study start-up activities at a site.
• Bachelor’s degree in life sciences or equivalent preferred (6-10 years of experience in lieu of degree).
• Knowledge of clinical research processes and GCP.
• Excellent communication, interpersonal, and project management skills.
• Proficiency with Microsoft Office Suite.
• Ability to work independently, manage multiple priorities, and build relationships remotely.

Benefits & Diversity

We offer comprehensive benefits including PTO, paid medical/dental/vision, HSA, disability and life insurance, 401k, and a culture of growth and inclusion. We are committed to diversity and equal opportunity employment.