Senior Clinical Research Associate

Company: Altasciences
Location: Cypress
Posted on: May 12, 2022

Job Description:

Job Summary

PLEASE NOTE: This position requires monitoring onsite, at our Cypress, Ca. headquarters location; other than monitoring onsite, this is a remote position. Local candidates are preferred however, you may choose to relocate at your own expense.

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

The Senior Clinical Research Associate (CRA) reports to the Director, Monitoring Services. The SCRA performs monitoring activities for clinical research projects according to the Clinical Monitoring Plans (CMPs) to assess the studies progress at assigned investigator sites (either on-site or remotely) and to ensure projects are conducted, recorded, and reported in accordance with the Protocol, Altasciences and Sponsor (when applicable) standard operating procedures (SOPs), ICH-GCP and applicable local and federal regulatory requirements.

The Senior CRA coordinates the monitoring activities at the site level and is the main contact person for any questions (internal/external) related to the monitoring activities.

Essential Job Functions

Create Clinical Monitoring Plans (CMPs) and prepare required Site Initiation Visits documents -(e.g., Power Point presentations).
Perform site qualification, initiation, interim, and close-out visits (either on-site or remotely) -accordingly to the CMPs.
Document activities via confirmation letters, visit reports, follow-up letters, and any other study specific documents as per the CMP.
Perform Source Documentation Verification (SDV) of source documents.
Perform dosing observations and/or observe Investigational Products (IPs) dispensation.
Verify clinical data entered in the Case Report Forms (CRFs) and/or electronic CRFs
(eCRFs).
Apply query resolution techniques and provide guidance to site staff as necessary, driving -queries resolution within agreed timelines.
Review the Investigator Site Files (ISFs).
Review Investigational Products (IP) inventory, reconciliation, and storage conditions.
Review and track Serious Adverse Events (SAEs).
Review study Protocols, Informed Consent Forms (ICFs) and any other study-specific documents.
Responsible for leading complex projects and involving multiple resources.
Interprets data to recommend plans and tactics.
Provides advice, guidance, and answers to management on sensitive strategic matters. -pertaining to the entire organization.
Advise study site personnel on the Protocol, study-specific documents, and applicable regulatory -requirements in collaboration with assigned project team members.
Ensure monitoring SOPs and templates are up-to-date and update them as required.
At the site level: Assist with planning/scheduling, assigning, tracking, and overseeing the -monitoring activities, including the internal reports revision.
Assists in managing and helping create clinical trial tracking metrics and reporting.
Mentoring, training for Clinical Research Associates
Review and approve monitoring documents.

Qualifications

Education
Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.

Experience/Training
Minimum of 5 years of clinically related experience, of which a period of 2 years is preferable in -clinical research monitoring or equivalent experience.
Knowledge of clinical research industry, terminology, and practices.
Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable -regulations.
Strong verbal and written communication skills.
Familiarity with EDC systems; ability to learn required systems quickly and to train others, -especially site staff.
Ability to establish and maintain a good working relationship with site personnel/ -colleagues.
Ability to work both in a team and independently.
Ability to facilitate team meetings and teleconferences.
Ability to present at internal study team meeting(s).
Proficient with Microsoft Office Word, Excel, and Power Point.
Strong planning and organizational skills and the ability to work effectively and efficiently in a -dynamic environment with competing projects and deadlines.
Ability to travel.

PLEASE NOTE: This position requires monitoring onsite, at our Cypress, Ca. headquarters location; other than monitoring onsite, this is a remote position. Local candidates are preferred however, you may choose to relocate at your own expense.

Keywords: Altasciences, Cypress , Senior Clinical Research Associate, Healthcare , Cypress, California