Health Science Specialist

Job Description

Job Description

Supports the enrollment of patients into clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.

• Collaborates with the principal investigator to meet or exceed study enrollment.

• Reviews the study design and inclusion/exclusion criteria with physician and patient.

• Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance and provides close monitoring of subjects while on study.

• Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review. Monitors data for missing or inaccurate data and respond to queries.

• Creates study specific tools for source documentation when not provided by sponsor.

• Collects, completes, and enters data into study specific case report forms or electronic data capture systems.

• Generates and tracks drug shipments, device shipments and supplies as needed.

• Assists with sample collection to include environmental sample collection, packing and shipping of samples.

• Assists with study relevant forms required for various regulatory and oversight committees.

• Reports and follows up on serious adverse events as necessary.

• Implements study-specific communications.

• Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications.

• Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations.

• Attends study specific on site meetings, Investigator meetings, conference calls and monthly CRC meetings as required or asked to do so.

• Apprises principal investigator of all study specific medical issues for guidance.

• Assists Sponsor, VA, FDA, IRB and other audit teams as needed.

• Reviews and responds to any monitoring and auditing findings

• Maintains patient confidentiality according to ethical and legal requirements.

• Assists in providing coverage for other projects and investigators as necessary or when asked to do so.

• Practice and adhere to the "VA Rules of Behavior."

• Performs other related duties as assigned by management.

SUPERVISORY RESPONSIBILITIES:

• This job has no supervisory responsibilities.

QUALIFICATIONS:

• Bachelor's Degree (BA) from four-year college or university, or four years of related experience and/or training, or equivalent combination of education and experience.

• Certificates, licenses and registrations preferred but not required:

o Specialty research certification such as ACRP’s CCRA, CCRC, ACRP-CP or SOCRA’s CCRP.

• Computer skills required: Microsoft Office Suite

• Other skills required:

o Working knowledge of medical and research terminology.

o Working knowledge of federal regulations for human subject protections and Good Clinical Practices (GCP).

o Ability to communicate and work effectively with a diverse team of professionals.

o Excellent organizational and prioritizing capabilities.

o Strong computer skills with demonstrated abilities using clinical trial database, electronic data capture.

o Excellent interpersonal skills, detailed oriented and meticulous.

o Excellent professional writing and communication skills.

o Ability to demonstrate proficient achievement of ‘Intermediate CRC’ based on ACRP Core.

o Specimen and/or tissue collection, handling & processing.

o Phlebotomy experience