The Senior Clinical Research Associate (Sr. CRA) is responsible for interfacing with investigative sites to monitor the conduct and assess the progress of clinical research studies to ensure compliance with protocol(s) and applicable MedSource or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines, and any additional applicable regulations as required. With limited supervision, the Sr. CRA is responsible for the management of multiple investigative sites across multiple clinical trial studies, ensuring the safety of the subjects and integrity and validity of the study data are maintained.
DUTIES AND RESPONSIBILITIES:
- Performs onsite Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff are adequately qualified and the site’s activities are in compliance with the clinical trial protocol and all applicable governmental and regulatory/ethics regulations.
- Reviews study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discusses discrepancies with investigative site staff.
- Communicates with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.
- Reviews regulatory documentation/file at the site for completeness, collects updated forms as applicable.
- Trains investigative site staff as necessary.
- Provides regular updates to project manager regarding the status of assigned sites (i.e., screening, enrollment, etc.)
- Notifies project manager immediately of any suspected fraudulent and/or misconduct activities.
- Attends team/sponsor teleconferences and/or training meetings as required.
- Attends investigator and/or study coordinator meetings, assists with event planning, develops documents/handouts, and/or participates as needed.
- Assist with review and revision of MedSource SOPs/WPGs.
- Attends and completes CRA field evaluations and assists with creation of CRA training tools.
- Assists with review of trip reports for the project team.
MINIMUM JOB REQUIREMENTS/ QUALIFICATIONS:
- BA/BS degree, or equivalent education and experience.
- At least 4 years of clinical research experience (including monitoring).
- Must possess a valid driver’s license and maintain a personal credit card with acceptable credit rating or have an available line of credit for charging travel expenses prior to reimbursement.
- Ability to travel extensively (driving and/or flying) including overnight stays. Travel may range from 50% to 80%.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent communication skills and ability to interact competently and professionally (both verbal and written) at all levels within a complex clinical research environment.
- Strong problem solving and decision-making skills, flexibility and adaptability
- Ability to assist with identifying potential investigators and perform feasibility to assess compatibility for trials.
- Knowledge of and ability to perform the following monitoring tasks: regulatory document review, source data verification, (e)CRF review, drug accountability and study supply inventory, and documenting the above activities including any identified issues and action items for resolution.
- Ability to develop and deliver presentations and effectively convey information.
- Ability to review past and current patient medical records and history for assessing protocol compliance and data verification.
- Ability to establish and follow data review guidelines.
- Ability to provide technical advice, guidance, and support to professional staff in area of specialty.
- Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.
- Possess MS Office Suite computer skills.
- Ability to maintain professional composure when found in stressful work situations.
- Manage time well and follow through on all pending issues and action items to completion.
CONDITIONS OF EMPLOYMENT:
- Verification of educational requirements, background check, employment history, professional references, and certifications/training.
- Proof of valid driver’s license and credit card.
WORKING CONDITIONS AND PHYSICAL EFFORT:
Work involves approximately 50%-80% travel.