Site Manager

DM CLINICAL RESEARCH GROUP•Houston, TX

84d

About The Position

The Site Manager ensures that quality research is conducted at assigned investigative sites in accordance with sponsor protocols, FDA regulations, and ICH/GCP guidelines, while providing high-quality data to sponsors. The role also supports study enrollment targets and company goals. The Site Manager supervises assigned site staff under the supervision of the Site Director or Director of Site Operations and manages clinical trials from first patient first visit through study closeout.

Requirements

At least 4 years of clinical research coordinator experience.
At least 2 years of management experience at a clinical research organization.
Strong teamwork, organizational, interpersonal, and problem-solving skills, with attention to detail.
Critical-thinking, active-listening, reading-comprehension, speaking, and writing skills appropriate to the audience and work.
Ability to multitask, meet deadlines, and work independently and cooperatively with interdisciplinary teams.
Strong computer skills in relevant software and clinical systems.
Comprehensive knowledge of FDA regulations, ICH-GCP, and ISOs.
Proficient verbal and written English communication and comprehension skills.

Nice To Haves

Bachelor's degree preferred.
Advanced degree preferred.
Certified Clinical Research Coordinator (CCRC) certification or equivalent certification preferred.
Proficient bilingual English/Spanish verbal and written communication and comprehension skills preferred.

Responsibilities

Complete required training, including ICH-GCP and IATA certifications, in a timely manner.
Maintain working knowledge of FDA regulations, ICH-GCP guidelines, organizational SOPs, guidance documents, and assigned study protocols.
Supervise and support the performance of assigned site staff under the supervision of the Site Director or Director of Site Operations.
Complete relevant study training before study start and on an ongoing basis, including protocol, amendments, study manuals, EDC, IVRS, and other applicable electronic systems training.
Ensure applicable training is completed before staff perform study tasks.
Prepare for sponsor and CRO visits and follow up on resulting action items in a timely manner.
Ensure the latest versions of protocols, informed consents, study manuals, and other study documents are used and implemented at assigned sites.
Manage clinical trials from first patient first visit through closeout in accordance with protocols, study documents and manuals, ICH-GCP, FDA regulations, ALCOA-C standards, organizational SOPs, and guidance documents.
Ensure data quality, subject retention, compliance, and timely, adequate study data reporting.
Manage staff, facilitate training, communicate job expectations, and coach, counsel, or discipline employees as applicable.
Develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
Communicate and implement senior management's strategic goals with the site team.
Work toward sponsor enrollment goals and weekly, monthly, and quarterly site objectives.
Attend required company meetings and submit administrative paperwork within company timelines.
Occasionally attend out-of-town Investigator Meetings.
Conduct patient consent discussions, explain study procedures, risks, benefits, and alternatives, and ensure patient comprehension before obtaining consent.
Facilitate communication among patients, healthcare providers, and research staff.
Perform other duties as assigned by management.